Gilead Colorado, Inc. is located near the foothills of the Rocky Mountains between the cities of Denver and Boulder. We have multiple openings for B.S., M.S. and Ph.D. level professionals to help us fulfill our vision of discovering, developing and commercializing medications to treat life threatening cardiovascular diseases. We are curently seeking the following:
Job Posting Title: Sr. Clin. Res. Scientist Requisition Number: 623 State: Colorado
Specific Responsibilities: Requires knowledge of pharmacokinetics, in vitro and in vivo drug metabolism. Training and experience in pharmacokinetic/pharmacodynamic modeling and simulation using WinNonlin, NONMEM or other relevant software is highly desirable. Knowledge of bioanalysis using HPLC-MS/MS is a plus. This position is responsible for all aspects of clinical science including research, developing and writing study protocol, study summaries and clinical study reports working in close association witha cross functional clinical, biometrics and regulatory team. This position will be responsible for contributing to study design and implementation of study designs across phase 1 through phase 4 studies, with special emphasis on clinical pharmacology.
Essential Duties and Job Functions: -Interfaces with staff to share scientific and clinical information and consistent practices. Leads protocol review discussions concerning scientific and procedural aspects of study design. -Serves as resource for junior staff. Oversees the scientific aspects of clinical studies throughout duration of study. -Adheres to strict regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs. -Prepares study protocols, amendments, specific sections of study manuals and Investigator meeting notebooks, and other documents as needed. Supervises or assists other CRS staff with preparation of above. -Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis Plans. -Helps insure consistency across protocols. Presents scientific information if needed. Addresses questions regarding scientific and related procedural issues from Investigators. Coordinates and implements ongoing data for internal analysis and review. -Coordinates the preparation and/or review of data listings, summary tables, study results, scientific presentations, and manuscripts for publication. -Coordinates the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and NDAs. -Determines the functions most critical to company success and supports priorities within functional area. -Anticipates fairly complex obstacles and client difficulties and implements solutions that meet goals. -Creates effective teams with a clear sense of direction. -May lead two or more specific components of departmental strategic initiatives.
Knowledge, Experience & Skills: -Excellent verbal and written communication skills and interpersonal skills are required to maintain working relationship with team members to ensure scientific integrity of clinical studies. -Is sought out for advice by others within the company to help make better decisions and resolve problems. -Examines functional issues from a broader organization perspective. -Must be able to design and use all available vehicles for effective scientific communication within the company. -Good working knowledge of cardiology and/or pulmonology, treatment, and clinical management along with a good general working knowledge of infectious diseases. -Knowledge of clinical trial design to develop specific study concept sheets and protocols is required. -Typically requires a BS degree in Biological Sciences, health care or related field and minimum 11 years of relevant experience or a MS degree and minimum 9 years of relevant experience. -Typically a higher degree Pharm.D or Ph.D. in clinical research or clinical pharmacology and experience in a pharmaceutical company or contract research organization along with knowledge of clinical trial design and experience with protocol/report writing is preferred.
External website http://gilead.apply2jobs.com/index.cfm?fuseaction=mExternal.showJob&RID=623&CurrentPage=1
Contact email address: gemick@usachoice.net - 7th May 2008 [1490]
Senior Research Investigator Princeton, New Jersey
Job Description:
- Lead the design, analysis, interpretation and reporting of pharmacokinetic, drug disposition, and drug metabolism data from clinical studies for compounds in Oncology-Immunology utilizing state of the art technology in support of clinical development plans.
- Perform pharmacokinetic and pharmacodynamic modeling, contribute to PK related regulatory documents and draft PK sections in support of clinical development plans, and provide PK perspective on cross functional teams.
- Participate in regulatory interactions as needed as well as evaluate feasibility of clinical studies and provide input to the design and review of clinical protocols.
- You must be at the forefront of scientific literature in the areas of drug metabolism, pharmacokinetics pharmacodynamics and clinical pharmacology.
- Serve as a mentor to junior level PK scientists.
- Ph.D. in pharmacology or pharmacokinetics or a PharmD with a minimum of 0-3 years experience gained through direct industry experience in Clinical Pharmacology
Contact email address: gemick@usachoice.net - 7th May 2008 [1489]
Sr. Research Investigator Princeton, New Jersey Job Description:
- Lead the design, analysis, interpretation and reporting of pharmacokinetic, drug disposition, and drug metabolism data from clinical studies for compounds in Cardiovascular-Metabolic Disease utilizing state of the art technology in support of clinical development plans.
- Perform pharmacokinetic and pharmacodynamic modeling, contribute to PK related regulatory documents and draft PK sections in support of clinical development plans, and provide PK perspective on cross functional teams.
- Participate in regulatory interactions as needed as well as evaluate feasibility of clinical studies and provide input to the design and review of clinical protocols.
- You must be at the forefront of scientific literature in the areas of drug metabolism, pharmacokinetics pharmacodynamics and clinical pharmacology.
- Serve as a mentor to junior level PK scientists.
- Ph.D. in pharmacology or pharmacokinetics or a PharmD with a minimum of 0-3 years experience gained through direct industry experience in Clinical Pharmacology
6th May 2008 [1488]
ROCHE PALO ALTO OPPORTUNITY-PHARMACOKINETICS/PD/PD MODELING: The successful candidate will provide scientific and technical leadership to a group of specialized scientific professionals. A detailed knowledge and a proven track record in the following areas are required:
- Pharmacokinetics (compartmental and physiological). Specialized knowledge including WinNonLin, GastroPlus and SimCYP highly preferred.
- PK/PD modeling: Specialized knowledge including NonMem, MatLab, S-Plus highly preferred.
QUALIFICATIONS: PhD/equivalent and typically at least five years of directly applicable experience. Must have a proven track record in establishing productive relationships with key partner groups (i.e. DMPK project representatives, Clinical Pharmacology, Pharmaceutics and Safety). Must have a demonstrated ability to work across sites with other M&S groups (DMPK in Basel and Clinical M&S), to prioritize projects and ensure the delivery of global M&S needs. Must possess theoretical and technical mastery of modeling and simulation field and a proficiency in related fields (general ADME science, pharmaceutics, clinical pharmacology). Must have a strong external scientific reputation acquired through scientific interactions and research publications as well as proven theoretical, technical, and managerial leadership skills. Problem solving skills, and experience in leadership and management of a group of scientific professionals are essential. Must possess the ability to critically review the work of others and to develop creative solutions to complex problems along with the ability to effectively communicate across all levels, including effective negotiation skills.
External website http://paloalto.roche.com/careers/Careers.html
5th May 2008 [1487]
Scientist II/Sr. Scientist I Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) is focused on becoming a global leader in the research, development and commercialization of novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections. Founded in 1992, Cubist is headquartered in Lexington, MA. Cubist Pharmaceuticals, Inc. is a EOE. To apply, please visit www.cubist.com and click on the Careers tab. You will be prompted to create a candidate profile before applying.
Position Summary As a Clinical Pharmacokinetic Scientist in the Clinical Research Department he or she will have responsibility for the design, conduct, analysis and reporting of clinical PK or PK/PD studies. He/she will participate in developing the clinical pharmacokinetic of portions of Cubist\0x00s daptomycin development programs as well as those of partners. Will provide PK/PD support for two IND candidates in development. Specific responsibilities will include: clinical PK/PD study design, PK analyses and study result interpretation, in-house PK/PD analyses and report finalization, and preparation of integrated clinical PK summaries for IND and NDA submissions. Provides PK/PD support for in-licensing compounds and drug discovery programs. Interacts with contract research laboratories in reviewing bioanalytical methods, validations and study results as well as in preparing PK or PK/PD analysis plans and reviewing and approving PK reports from CROs.
Duties and Responsibilities * Design clinical pharmacokinetic program for new IND candidates * Provided PK/PD expertise in the interpretation of clinical study results * Perform PK modeling to optimize efficacy, safety and understanding of Cubist\0x00s compounds * Provide PK backup to Director, Pharmacokinetics * Serve as PK representative on selected partner or in-house project teams * Review PK characterisitics of IND candidates and in collaboration with Discovery and Nonclinical scientists determine dosing regimen to optimize for efficacy and minimize toxicity * Collaborate with Discovery Research in the PK screening of analog candidates * Evaluates PK issues for in-licensing assessments * Review bioanalytical method development and validation and review clinical plasma concentration data: approve bioanalytical reports * Prepare all relevant PK sections of clinical regulatory documents (study summaries, CTD tables, Annual Reports, Investigator Brochures, PIs, and integrated summaries for regulatory submissions) and respond to issues
Qualifications A. Education/Certification: Successful candidates will have a Ph.D in pharmacokinetics or pharmaceutical sciences or a Pharm D in pharmacy. Post-doctoral experience preferred.
B. Experience 2 - 5 years of relevant experience (with Ph. D/Pharm. D degree) in clinical pharmacokinetics within the pharmaceutical or biopharmaceutical industry. Candidates must be familiar with clinical pharmacokinetic and pharmacodynamic software and have conducted these analyses as well as performed pharmacokinetic/pharmacodynamic modeling. A background in POP PK and anti-infectives is desirable. Needs excellent verbal and written communication skills and must function well in team situations
Benefits Our outstanding benefits package includes: 100% vesting in our 401K plan, choice of HMO/PPO medical plan, employee stock purchase program, dental, life and disability insurance, tuition reimbursement, flexible spending accounts and 3 weeks vacation. In addition, we have unique extras such as: on-site massage therapy, 12 holidays, 4 of which are floating, EAP benefit focusing on work life balance issues and frequent celebratory parties!
Search Firm Representatives: Please Read Carefully. Cubist is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Cubist via email, the Internet or directly to hiring managers at Cubist in any form without a valid written search agreement in place for that position will be deemed the sole property of Cubist, and no fee will be paid in the event the candidate is hired by Cubist as a result of the referral or through other means. Note: Any search agreement entered into prior with Cubist to January 2006 is hereinafter void.
Search firms are essential to the recruitment and staffing efforts at Cubist and we value the partnerships we have built with our preferred vendors. For this reason, Cubist has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Staffing Consultant at Cubist in place in order for a fee to be paid for any candidate referrals. submitted by jodi.brusewitz@cubist.com
Jodi Brusewitz Talent Acquisition Coordinator Human Resources, Talent Acquisition Team Cubist Pharmaceuticals 65 Hayden Avenue Lexington, MA 02421 Telephone: 781-860-8652 Fax: 781-860-1452 email: jodi.brusewitz@cubist.com
External website http://www.cubist.com
Contact email address: gemick@usachoice.net - 1st May 2008 [1486]
Associate Director Clinical Pharmacology Cardiovascular-Metabolic Disease Group NEW JERSEY
JOB DESCRIPTION:
- Lead the clinical pharmacology development of cardiovascular and metabolic disease programs in full development and life cycle management.
- Contribute to the design, planning, execution and interpretation of studies conducted in early clinical development, particularly results of human clinical trials in phases I to II of development.
- Manage the clinical pharmacology profiling for cardiovascular and metabolic disease drugs, including drug interaction, age and gender, renal and hepatic impairment, food effect, and Absorption Distribution Metabolic Excretion studies in healthy volunteers.
- Responsible for the creation and design of the Clinical Pharmacology plan in full development and life cycle management.
- Contribute to the Clinical Pharmacology aspects in early clinical development.
- Manage the clinical study process from protocol development to final study report through regulatory dossier production, prepare protocols and conduct clinical studies of products that have been determined to satisfy a medical need and offer a commercial potential.
- Serve as a clinical pharmacology expert across the organization and to government regulatory agencies.
- Responsible for the preparation of the Clinical Pharmacology components of regulatory submissions and responding to regulatory authority questions.
- Represent the department at the development matrix team level to ensure integration of the Clinical Pharmacology plan with the global development plan.
- Ph.D. in pharmacology or pharmacokinetics or a PharmD with a minimum of 5 years experience gained through direct industry experience in Clinical Pharmacology.
- Experience in being a Study Director contributing to the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation, review and reporting of results for multiple studies of different types for multiple projects in the Cardiovascular or Metabolic Disease areas is required.
- Must have experience developing at least one or more clinical pharmacology plans.
- Demonstrated experience in preparing regulatory submissions, including full NDAs or significant sNDAs, as well as multiple INDs.
- Experience responding to regulatory questions related to pharmacokinetics and pharmacodynamics.
- Application and knowledge of current practices and issues in the following areas for multiple projects clinical pharmacology, bioanalytical, biopharmaceutics, regulatory, non clinical metabolism and pharmacokinetics, pharmacology, and toxicology.
- Knowledge of modeling and simulation techniques and related data interpretation on multiple projects is desirable.
- Proven leadership skills working in a highly matrixed organization with a successful track record as a direct supervisor, mentor and developer of people.
- Strong project management
Contact email address: broseberry@cartermackay.com - 30th Apr 2008 [1485]
Principal Investigator/Associate Director/Director (multiple positions)
Identify preclinical data (e.g., ADME, pharmacology, toxicology, etc.) needed for product evaluation and design of clinical studies and development plans. Design and interpret preclinical PK and Phase I and II clinical studies Perform Pk analysis, modeling and simulation using SAAMI,WinNonLin, ADAPT,and NONMEM. Interact with regulatory authorities and author regulatory documentation Participate with various internal and external disciplines in the research and development of selected drug products. PK modeling and Population PK modeling experience and clinical development experience are essential.
Qualifications: PhD in Pharmacokinetics or related discipline with a minimun of 4 years industrial pharmaceutical/biotech experience within the US.
Contact email address: broseberry@cartermackay.com - 30th Apr 2008 [1484]
Senior Scientist/Leader, Biotherapeutics PK
This position requires a Ph.D.in Pharmacokinetics or related discipline with at least 5 years of industry and/or related DMPK experience. Prior experience in the development of monoclonal antibody biotherapeutics is preferred. The candidate should have the following:
- Thorough knowledge of pharmacokinetic and pharmacodynamic principles
- Strong knowledge of preclinical and clinical pharmacology
- Project team experience and GLP knowledge
- Experience in preparation of regulatory submissions
- Understanding of small molecule and biotherapeutic method validation, bioanalytical sample analysis, and various instrumentations (HPLC, LC/MS/MS,Biacore, Elisa, etc.)
- Experience with analytical software such as WinNonlin, NONMEM, or similar programs
- Experience in or monitoring outsourced studies
Contact email address: recruitment.harrogate@covance.com - 29th Apr 2008 [1482]
Covance is one of the World's largest and most comprehensive drug development services companies with annual revenues greater than $1.4 billion, global operations in more than 20 countries, and more than 8,700 employees worldwide. We offer drug development solutions from preclinical through commercialisation stages.
At our Phase 1 Clinical Pharmacology site in Leeds, UK, we are currently recruiting for a Senior Pharmacokineticist. The exact extent of responsibilities for this role will depend upon the level of experience the chosen candidate brings to the position.
Key duties will be based around providing PK and PD data analysis and interpretation service to the Pharmacometrics Division at Covance. In addition, the role involves supporting Clinical Operations at Covance CRU in terms of advising on PK/PD-related aspects of study design, providing interim PK and PD analyses to assist in dose escalation decisions. plus overseeing toxicokinetic analysis performed by the department.
The role will involve reviewing study designs, providing analysis plans, performing/reviewing non-compartmental PK analysis and interpretation, together with compartmental PK, and PK/PD modeling.
The successful candidate will typically possess a minimum of 3 years experience in pharmacokinetic and / or pharmacodymanic analysis, with a Bioanalytical Chemistry or a Biological Life Sciences Degree.
For full details of the duties please visit www.covancecareers.com Job ref 11743BR. If you are interested in applying for this role, please do so directly on-line.
External website http://www.covancecareers.com
Contact email address: phillip@tompkinsassociates.com - 24th Apr 2008 [1480]
A 100 Best Companies to Work For from Fortune Magazine
Principle Duties: - Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential. - Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis. - Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and goals and objectives. - Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of lead candidates and post-marketed products. - Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives. - Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies. - Submits and administers employee performance standards and actively develops personnel within the team. - Provides timely and quality documents (i.e., protocols, clinical study reports (CSRs), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects. - Represents Clinical Pharmacology at various clinical meetings and project team meetings.
Principle Responsibilities: - Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and R&D objectives. - Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities. - Provide effective and timely mentoring and support for subordinates. - Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints.
Additional (enhancing) skills: - Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation. - Familiarity with relevant SOPs and document management systems - Good knowledge of GCP requirements. - Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology. - Excellent written and oral communication skills.
Phillip Tompkins Tompkins Associates, Inc. 972 233 8333 phillip@tompkinsassociates.com
Contact email address: gemick@usachoice.net - 24th Apr 2008 [1479]
CLINICAL PHARMACOLOGY ONCOLOGY IMMUNOLOGY GROUP NEW JERSEY
JOB DESCRIPTION:
- Clinical pharmacology development of Oncology-Immunology programs in full development and life cycle management.
- Contribute to the design, planning, execution and interpretation of studies conducted in early clinical development, particularly results of human clinical trials in phases I to II of development.
- Clinical pharmacology profiling for Oncology-Immunology drugs, including drug interaction, age and gender, renal and hepatic impairment, food effect, and Absorption Distribution Metabolic Excretion studies in healthy volunteers.
- Aid in the creation and design of the Clinical Pharmacology plan in full development and life cycle management.
- Contribute to the Clinical Pharmacology aspects in early clinical development.
- Aid the clinical study process from protocol development to final study report through regulatory dossier production, prepare protocols and conduct clinical studies of products that have been determined to satisfy a medical need and offer a commercial potential.
- Aid in the preparation of the Clinical Pharmacology components of regulatory submissions and responding to regulatory authority questions.
EDUCATION REQUIREMENTS:
- Ph.D. in pharmacology or pharmacokinetics or a PharmD with a minimum of one year Postdoc experience in Clinical Pharmacology Oncology.
Contact email address: jchapman@haallc.com - 18th Apr 2008 [1475]
Associate Director Pharmacokinetic and Pharmacodynamic sciences
The department of Pharmacokinetics and Pharmacodynamic Sciences at this top Biotech is seeking a senior Ph.D. level Scientist who is driven to understand the pharmacokinetics and pharmacodynamics of novel drug candidates in the area of BioOncology. This individual will be responsible for leading a group of scientists responsible for the clinical PK/PD activities on molecular entities in late stage clinical development. This person will work in close partnership with Clinicians, Biostatisticians and project teams and will serve as a liason between our department and the BioOncology counterparts in these groups. Responsibilities will include planning, reviewing, study designs, analysis plans, data analysis, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings. Additionally this individual will also be directly involved in projects and project teams.
Requirements A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences or related discipline with at least 8 years of industry and/or related post-doctoral PK/PD and/or POP PK modeling experience is required. Familiarity and experience with standard modeling software (NONMEM, ADAPT II and WinNonlin) and the ability to plan, organize, and analyze experimental/quantitative data are essential. Experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of GCP and regulatory guidelines is highly desirable. Experience in Oncology drug development is required. Leadership abilities are a plus. The candidate must have excellent communication skills and the ability to work effectively on interdepartmental project teams.
Those interested Please send your updated CV to jchapman@haallc.com or call 704-333-5211.
Contact email address: mark.mcphee@princetonone.com - 17th Apr 2008 [1474]
Senior Scientist-Bioanalytical Development
Growing, well-respected pharmaceutical innovator firm seeks an industry-experienced Bioanalytical Scientist to join their multidisciplinary drug discovery department. This position is located in North Carolina. For consideration, send your resume as a MS Word document.
Description: The primary focus of this position is development of LC-MS/MS-based analytical methods for qualitative and quantitative (including low level) determination of small molecule NCEs and their metabolites found within biological matrices. Additional duties will include application of MS and other analytical techniques and software for metabolite identification.
Requirements: -M.S. with 5+ years or Ph.D. and 2+ years of pharmaceutical industry experience conducting bioanalytical research to support the discovery of new small molecule drugs. -Hands-on fluency with chromatographic separations using LC instrumentation coupled with quantitation and structural elucidation using MS/MS instrumentation and software that aids fragment identification. -Familiarity with development of robust bioanalytical methods suitable for GLP work is desired. -Experience with several methods of sample prep is required (eg, liq-liq and SPE) as is familiarity with 96-well high throughput analysis. -Excellent organizational and communication skills and a high energy level.
Keywords: small molecule, pharmaceutical, NCE, drug discovery, bioanalytical, DMPK, LC-MS/MS, LC/MS/MS, qualitative, quantitative, metabolite identification, 96-well
Contact email address: chad.barney@regeneron.com - 16th Apr 2008 [1473]
Located in the beautiful Hudson Valley region of New York, Regeneron is a biopharmaceutical Company that discovers, develops, and commercializes therapeutic medicines for the treatment of serious medical conditions. Regeneron currently markets ARCALYST(TM) (rilonacept) Injection for subcutaneous use for the treatment of a rare, inherited, inflammatory condition. The company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases and inflammatory diseases, and has preclinical programs in other diseases and disorders.
With a strong research base and product focus, Regeneron is able to understand thoroughly the biology of specific disease states, discover potential therapeutic candidates and evaluate product candidates in clinical trials. Regeneron has developed several proprietary platform technologies, which it has incorporated into a comprehensive system that allows it to accelerate the discovery and design of fully human antibodies and move these candidates rapidly into clinical development.
Regeneron Pharmaceuticals, Inc. is seeking a scientist in Preclinical development. The individual must have a PhD in Pharmacology, Pharmaceutics, Physiology, Biochemistry or a related discipline with at least two years of relevant laboratory experience. Their main goals will be to perform pharmacokinetic / pharmacodynamic studies and to support toxicological studies required for the clinical development of drug candidates. Specific duties will include rodent pharmacokinetic studies, assay development and the analysis of pharmacokinetic and toxicological samples. The individual must possesses excellent technical skills, be able to independently conceive and execute experiments, as well as introduce new concepts or strategies. In addition, they must be able to both effectively direct others and demonstrate evidence of a creative and critical approach to scientific problem solving. Critical skills include experience with handling small animals and developing and performing ELISA-based assays. An understanding of assay development and knowledge of PK/PD are a must.
We offer an extremely competitive compensation and benefits package to all our employees, including stock incentives, 401k with company match as well as the expected health and welfare benefits. Comprehensive relocation benefits are available, as required.
An EOE M/F/H/V
External website http://knxaweb.kenexa.com/Kr34Regeneron/cc/cc-search-jobs.jsp?pId=1
Contact email address: broseberry@cartermackay.com - 14th Apr 2008 [1465]
Several positions avialable with top tier clients in the area of preclinical PK/PD research. Looking for individuals with industrial experience in drug metabolism, CYP inhibition, DDI, radio labeled compounds, LC/MS/MS, ADME, and in vivo study execution. Also beneficial is experience in the preparation of regulatory documents such as IND's and NDA's. Knowledge of WinNonlin and LIMS is a plus. Ph.D's with 2+ years experience Masters with 5+ years experience BA/BS with 5+ years experience Send resume as word document to broseberry@cartermackay.com
Contact email address: rajkumar@makrotech.com - 10th Apr 2008 [1451]
Director Oncology PD Biomarker Development in Bay Area, CA We currently have a permanent position for Director Oncology PK/PD Biomarker for a Biotech client in Bay Area, CA. The person will lead a big team of research scientists and associates. Its a strategic role and primary responsibility is to drive bringing the drugs to market by identifying relevant PD-biomarkers Excellent Salary with target bonus. If you are interested to know more about this role, contact me at your soonest convenience and I will be more than happy to assist you. Thanks Raj rajkumar@makrotech.com Tel: 973-481-0100 Ext: 3021
Contact email address: hresources@acclaimpharma.com - 10th Apr 2008 [1448]
Manager of Clinical Operations Phase 1 unit (First in Man/Bioequivalence unit) Acclaim Pharma Research Inc., London, Ontario, Canada Primary Responsibility: Responsible for assisting in the planning, management, and execution of Phase 1 clinical trials and data collection activities; Development of the overall clinical plan, drafting and approval of protocols and essential study documents. Coordinates document review and approval processes. Scheduling and conducting interactions with various inside/outside groups to facilitate successful clinical trials. Previous experience in clinical development of investigational medications within and outside the U.S. is preferred.
Specific Responsibilities:
- Liaison with sponsors to obtain new trials
- Implementation of Phase I clinical trials (including in-house development of protocols, timelines and budgets).
- Management of drug supplies.
- Ensures budgets, schedules, reports and performance requirements are met.
- Organization of all aspects of clinical data management and analysis, clinical drug supply, central clinical laboratory, drug analysis laboratory, and other operational aspects of setting up, conducting, and reporting clinical trials of investigational agents.
- Preparation of requests for proposals (RFP).
- Prepares and submits the bid review analysis and presentation.
- Development/hiring/training of operational trial team members
- Coordinates training/orientation of new employees.
- Development of SOPs for clinical operations.
- Ensures all activities of clinical operations are in compliance with all applicable SOPs and government laws and regulations regarding clinical research.
Qualifications:
- Master’s degree or PhD preferred, with a minimum of a Bachelor’s degree
- Phase I experience an asset
- Strong analytical and problem solving skills
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
- Excellent interpersonal skills; strong verbal and written communication skills
- Thorough knowledge of IRB, HIPAA, and FDA regulatory requirements for the conduct of research.
- Solid project coordination/management and project planning skills
- Solid people management and conflict resolution skills
- Strategic planning experience
- Proficient in MS Office Suite
What's on offer Excellent package + benefits + Bonus Scheme Contact Please email CV and cover letter to: hresources@acclaimpharma.com Or Call 519-657-4222 ext 277
External website http://www.acclaimpharma.com
Contact email address: hresources@acclaimpharma.com - 10th Apr 2008 [1447]
Manager of Clinical Operations Phase 1 unit (First in Man/Bioequivalence unit) Acclaim Pharma Research Inc., London, Ontario, Canada Primary Responsibility: Responsible for assisting in the planning, management, and execution of Phase 1 clinical trials and data collection activities; Development of the overall clinical plan, drafting and approval of protocols and essential study documents. Coordinates document review and approval processes. Scheduling and conducting interactions with various inside/outside groups to facilitate successful clinical trials. Previous experience in clinical development of investigational medications within and outside the U.S. is preferred.
Specific Responsibilities:
- Liaison with sponsors to obtain new trials
- Implementation of Phase I clinical trials (including in-house development of protocols, timelines and budgets).
- Management of drug supplies.
- Ensures budgets, schedules, reports and performance requirements are met.
- Organization of all aspects of clinical data management and analysis, clinical drug supply, central clinical laboratory, drug analysis laboratory, and other operational aspects of setting up, conducting, and reporting clinical trials of investigational agents.
- Preparation of requests for proposals (RFP).
- Prepares and submits the bid review analysis and presentation.
- Development/hiring/training of operational trial team members
- Coordinates training/orientation of new employees.
- Development of SOPs for clinical operations.
- Ensures all activities of clinical operations are in compliance with all applicable SOPs and government laws and regulations regarding clinical research.
Qualifications:
- Bachelor’s degree required
- Phase I experience an asset
- Strong analytical and problem solving skills
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
- Excellent interpersonal skills; strong verbal and written communication skills
- Thorough knowledge of IRB, HIPAA, and FDA regulatory requirements for the conduct of research.
- Solid project coordination/management and project planning skills
- Solid people management and conflict resolution skills
- Strategic planning experience
- Proficient in MS Office Suite
External website http://www.acclaimpharma.com
Contact email address: mark.mcphee@princetonone.com - 8th Apr 2008 [1428]
Principal Scientist-Bioanalytical Chemistry
Emerging pharmaceutical firm in the Seattle area desires to expand their R&D capabilities. They seek a Bioanalytical Scientist with significant pharmaceutical industry experience geared toward the discovery of novel therapeutics. To be considered, please send your resume (in MS Word format) and cover letter to: Mark.McPhee@PrincetonOne.com
Description: Innovator firms seeks a talented Analytical Scientist to design and oversee the conduct of bioanalytical studies to support drug discovery and development. This position will report to the Director of Analytical Chemistry. Specific job duties will include:
-Develop extraction methods and bioanalytical methods to quantify the firm’s small molecule drugs and their metabolites from biological matrices; -Oversee analysis of samples from PK/TK and ADME studies and manage analytical GLP studies conducted at CRO’s; -Document methods and summarize results in reports for inclusion into regulatory filings; -Train and supervise bioanalytical personnel; -Communicate findings and results to management.
Requirements: -Ph.D. in Analytical Chemistry or a related discipline and 4+ years of pharma or biotech industry experience. GLP experience considered a plus. -Documented experience in analytical methods development for small molecules by mass spectrometry (LC/MS/MS, Triple Quad with ESI, APCI and HESI), HPLC (UV/VIS/fluorescence, electrochemical detectors, Corona CAD), and Ion Chromatography. -Experienced in quantifying small molecules and gases by GC with PDD or RGD. -Experienced in the development of extraction methods for compounds from biological materials and use of derivatization techniques to modify small molecules. -Demonstrated leadership and supervisory experience. -Excellent verbal and written communication skills. -Excellent time management, organizational and problem-solving skills.
Keywords: pharmaceutical, small molecule, bioanalytical, method development, PK/TK, ADME, GLP, CRO oversight, HPLC, LC/MS/MS, scientist, leadership
External website http://www.mrinetwork.com/pcrbin/recruiters.exe?action=details&recruiter_id=174365778035012
Contact email address: kbertels@prdus.jnj.com - 4th Apr 2008 [1422]
Scientist PK/PD – 0801759
Description
Johnson and Johnson Pharmaceutical Research and Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist, located in Raritan, NJ.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine
The candidate will assist the PK/PD Leader in the design of PK/PD studies and in development program strategy. The candidate will also discuss and advise as necessary/appropriate on scientific and pharmacokinetic (PK) related issues with the PK/PD Leader, Program Manager, and/or PK/PD Analyst. The candidate will participate in Clinical Pharmacology Phase 1 Working Groups as an active member and interact with Clinical Team members to ensure that pharmacokinetic related activities and issues are addressed. Act as a backup for PK/PD Leader when necessary at Clinical Team and other meetings. The candidate will develop/write/review protocol synopses and full protocols and assist PK/PD Leaders in the defense of these synopses/protocols within CP and at Protocol Review Committee meetings and perform and/or review PK and/or PK/PD data analyses utilizing approved software and ensure delivery of the final results within agreed timelines. The candidate will prepare abstracts, posters, and manuscripts for internal and external meetings or publications detailing current J&JPRD development work. The candidate will prepare and/or review and quality control of PK and PK/PD sections of Clinical Study Reports, internal and external presentations of top-line PK results of clinical studies, submission documents, Investigator Brochures, abstracts/publications, etc. As needed, the candidate will interact with internal and/or external contractors with regard to data analysis and report writing as well as establish and maintain strong working relationships with other functions involved in clinical studies, including clinical operations, bioanalytical, biostatistics, medical writing, and strategic outsourcing.
Qualifications A minimum of a BS degree in a physical or biological science discipline is required and 1 or more years of experience in the pharmaceutical industry is preferred. A basic understanding of pharmacokinetics (PK) and PK/PD is preferred and basic understanding of clinical development is desirable. Previous experience in the oncology therapeutic area is preferred. A working knowledge of MS Office is required, and a working knowledge of pharmacokinetic software (e.g. WinNonlin or similar) is preferred.Good oral and written communication skills are required.
If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!
Contact email address: kbertels@prdus.jnj.com - 4th Apr 2008 [1421]
Associate Director Clinical Pharmacology – 0802889 Description
Johnson & Johnson Pharmaceutical Research & Development, a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director Clinical Pharmacology, located in La Jolla, CA.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., La Jolla, develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, metabolic disorders, inflammation disorders and pain.
As Associate Director Clinical Pharmacology you are responsible for developing and directing clinical pharmacokinetic (PK) and clinical pharmacology (PD) activities, deliverables, and programs for products in early and late stage clinical development. Responsibilities of this position may include functional organization and management of individuals supporting drug development programs. Responsible for the proactive development, alignment, integration, and implementation of the clinical PK and PD development plans in support of the overall early and/or late development project(s). This also includes responsibility for initiating functional “challenge” and “review” of such plans. Manage the consistency, quality, compliance, and timelines of clinical PK and PK/PD input into Phase I to IIa protocols, PK and PK/PD analysis, and PK and PK/PD sections of investigator brochures, study reports, regulatory documents, and other documents in accordance with general company standards, internal and external guidelines, and processes. Active participation in Clinical Teams/Compound Development Teams. Provide direction to the PK/PD Program Manager (LD) in the PK/PD Working Group or other implementation teams, and to the PK/PD Scientist. Integrate discovery, pre-clinical and clinical data into clinical plans by using appropriate modeling and simulation tools, in conjunction with AM&S Scientists and other functional experts. Contribute to the identification, characterization and validation of potential biomarkers and/or surrogate markers and measurements in non-clinical and clinical studies and to the selection of Discovery NME candidates and of compounds stated to transition into early or late-stage development. Finally, contribute to the development of new concepts, technologies, and designs of preclinical and clinical PK and PK/PD studies.
Qualifications The successful candidate will have a PhD in Pharmaceutical, Medical or Biology Sciences, with a minimum of 3 years of industry experience or an equivalent Master degree with 5 years of relevant industrial experience. Knowledge on clinical drug development and a demonstrated knowledge of pharmacokinetics and pharmacology is needed. Working knowledge of pharmacokinetic/pharmacodynamic software (WinNonlin, NONMEM, Clinical Trial Designer). Experience in the application of PK/PD concepts in a therapeutic area would be a plus. Ability to effectively communicate to individuals and groups at various levels in the organization. Strong focus on delivering on the organizational objectives, proactively taking appropriate action, and seeking opportunities to improve the value delivered to the organization. You are able to build and maintain effective working relationships inside and outside the department and to work in a cross-functional team environment. Ability to diagnose issues and problems, develop alternative solutions, take decisions, and act with a sense of urgency. Understand and effectively use knowledge of emerging scientific and technological developments to successfully work with partners and internal customers. An in-depth understanding of the pharmaceutical science landscape and an eagerness to optimize that knowledge to improve the drug research and development process. Ability to work under pressure and to control the job by planning and prioritization are important. Ability to travel domestically and internationally, dependent on the project activities, approximately 10% is required.
3rd Apr 2008 [1420]
For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using human genetic information to develop novel medicines for serious and life-threatening diseases. Today, Genentech is among the world’s leading biotech companies, with multiple therapies on the market for cancer and other serious medical conditions. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset. The following opportunity exists in our South San Francisco, CA, headquarters:
Senior Research Associate/RA – DMPK
Responsibilities: The department of Drug Metabolism and Pharmacokinetics (DMPK) at Genentech is seeking a highly motivated individual to support pharmacokinetic and drug disposition studies enabling the discovery and development of small molecule drugs. The qualified candidate will conduct in vitro permeability and transport studies in support of Discovery and Development projects, as well as develop assays to investigate expression and functions of drug transporters.
Requirements: A Bachelor’s or Master’s degree in Biology, Chemistry or other relevant fields with a minimum of two years of experience is required. Excellent organization skills, strong verbal and written communication skills and flexibility are essential. Extensive experience in cell/tissue culture and molecular biology techniques is highly desirable. An understanding of pharmacokinetic concepts is a plus.
Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: www.gene.com/careers and reference Req. #1000020035. Please use “Web – Other” when a "source" is requested. Genentech is an Equal Opportunity Employer.
External website http://www.gene.com/careers
Contact email address: kbertels@prdus.jnj.com - 2nd Apr 2008 [1419]
Analyst PK/PD - 0803824
Johnson & Johnson Pharmaceutical Research & Development, a member of Johnson and Johnson's Family of Companies, is recruiting for an Analyst PK/PD, located in La Jolla, CA.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., La Jolla, develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, metabolic disorders, inflammation disorders and pain. The position is responsible for providing quality clinical pharmacokinetic and pharmacodynamic analysis for products in early and late stage development or post marketing development. This position forms the basis in which clinical pharmacokinetic/pharmacodynamic information is collected, organized, and analyzed prior to interpretation. They will also ensure information accuracy as related to pharmacokinetic (PK) samples (blood, plasma, urine, etc.) and, where applicable, pharmacodynamic samples (PD) during development of the Case Report Form. Constructs the appropriate database structure in collaboration with PK/PD Leader, PK/PD Scientist, and related functions and include consistency checks to ensure delivery of high quality PK and PK/PD data within a specified time frame. Plan and discuss PK Analysis with PK/PD Leader, PK/PD Scientist, and statistician in preparation of PK and PK/PD analysis and outputs Performs interim and full analysis for PK and PK/PD trials for Early and Late Development and post marketing trials Prepares PK and PK/PD results in tables and graphs for Summary Overviews, Study Summary results, Key PK Results, Clinical Study Reports, internal and external departmental data communications, and submission related documents Participates in departmental QC checks when applicable
Qualifications The successful candidate will have BA or BS in a scientific disapline or related field.Experience in the use of WinNonlin software and database management is a significant plus. Good understanding of the use of Microsoft suite of software products. Candidate must have the ability to build and enhance working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment. Ability to multi-task and prioritize assignments, establishing courses of action to ensure that work is completed efficiently (planning and organizing).
External website http://jobview.monster.com/GetJob.aspx?JobID=69623252&JobTitle=Analyst+PK%2fPD+-+0803824&fn=46&q=pk&
Contact email address: info@greylock-recruiting.com - 1st Apr 2008 [1418]
DMPK Scientist
Seeking an experienced and Drug Metabolism Scientist to perform in-vitro and in-vivo metabolite profiling and metabolite identification of the drugs in development.
Key Responsibilities:
- Plan, conduct, and interpret in-vitro and in-vivo drug metabolism studies.
- Metabolite profiling for radio labeled as well as non-radio labeled drug candidates in drug development stage.
- Metabolite characterization by using novel spectroscopic techniques such as LC-MS/MS, NMR etc.
- Summarize and discuss the study results in interdepartmental group meetings.
- Write reports for submission to regulatory authorities
- Participate in discussion on multidisciplinary drug development teams
- Collaborate with colleagues to design and implement overall drug development strategies.
Minimum Requirements
- Candidate must have a Ph.D. degree in organic chemistry, biochemistry, medicinal chemistry or a related field.
- Minimum of 2-3 years of relevant postdoctoral or industrial experience.
- Hands on experience on LC-MS instruments including triple quad, ion trap mass spectrometers and high resolution mass spectrometers.
- Should be able to handle radio-labeled material.
- In-depth understanding of biotransformation pathways, mechanism and techniques required for metabolite characterization.
- Overall understanding of metabolism and pharmacokinetics and its application within a drug development setting.
- Participate in broad-based interactions with internal/external collaborators
- Ability to work in a time sensitive multiple project environment
External website http://www.greylock-recruiting.com
1st Apr 2008 [1417]
Associate Director, Clinical Pharmacology
This is a new position that can either be filled in the UK or NJ as it reports to a manager in the UK. Notes from the hiring manager: It may be useful if we could read a brief synopsis from prospective candidates, which explains how they fit into a start-up Modeling and Simulation group. The ideal candidates will come from dedicated modeling & simulation functions in other pharma companies, or Clinical Pharmacology groups who are very hands-on involved with (directing) strategic application of data analysis during clinical development.
Description: The incumbent will be responsible for, but not limited to the following:
- Implementation of M&S strategies, including design and analysis of (population) PK and PK/PD studies, with the support of group members and through outsourcing.
- Conducting PK and PK/PD data analysis, using methods across the spectrum from noncompartmental to population approaches.
- Assist in compilation of PK and PK/PD analysis plans, datasets and reports in accordance with departmental SOPs.
- Interact with clinical, statistics and data management functions.
- Represent Eisai at major scientific and medical meetings.
- To maintain knowledge of PK, PK/PD and modelling and simulation approaches.
Qualifications:
- An astute pharmacokineticist with demonstrable, hands-on experience in population PK/PD, Modelling and Simulation, using NONMEM and S-Plus / R, SAS, Matlab, WinBugs.
- A higher degree with relevance to PK/PD, modelling and simulation.
- Experienced with strategic application of modelling and simulation to drug development, gained within the pharmaceutical industry (i.e. Pharma or CRO)
- Understanding of the requirements of GCP.
- Experience with working in multi-disciplinary teams
- Proactive with excellent communication, organizational and mentoring skills.
Kris Sanders Executive Recruiter Snelling Biopharm Division Toll Free: 800.756.7500 x 1388 Direct: 972.776.1388 Fax: 972.778.1278 Kris.Sanders@Snelling.com 12801 N. Central Exp. Suite 720 Dallas, TX. 75243
Contact email address: nvossela@janbe.jnj.com - 1st Apr 2008 [1416]
The department Global Clinical Pharmacology of Johnson & Johnson in Beerse –Belgium is searching for several :
(Sr.) PK/PD Scientists
What types of projects can a candidate expect to work on during the frist 6 monhts of his position: The candidate will work closely together with the PK/PD leader and be responsible for coordinating clinical pharmacokinetic and pharmacodynamic activities related to study design, implementation, analysis, and reporting of Clin Pharm sponsored and supported studies for compounds of our CNS/IM portfolio : candidate works on tapentadol - submission and is developing the IVIVC skills to be applied within the department;
Responsibilities: ·Establish and maintain strong working relationships with different departments as part of conducting clinical PK studies : i.e. Clinical Operations, Bioanalytical, Bio-statistics, Medical Writing, and Global Strategic Outsourcing. ·Participate in PK/PD Working Groups as an active member and interact with Clinical Team members to ensure that pharmacokinetic (PK) related activities and issues are addressed). ·Discuss and advise, as necessary/appropriate, scientific and PK related issues with the PK/PD Leader, Manager, and/or PK Analyst. Assist PK/PD Leader in the development strategy and design of pharmacokinetic and pharmacokinetic/pharmacodynamic (PK/PD) studies. ·Develop/write/review PK Protocol Outlines and PK and PK/PD sections of full protocols. Assist PK/PD leader and/or Manager in the defence of these outlines/protocols within PK/PD and at Protocol Review Committee meetings. ·Collaborate with Data Management, Bioanalytical, and Pharmacokinetic Analysts to ensure acceptability of PK and/or PK/PD data and timely delivery of database while maintaining high standards of quality and internal quality control. ·Perform and/or review PK and/or PK/PD data analyses utilizing approved software and ensure delivery of the final results within given timelines. Interact with and manage consultants and in-house contractors with regard to data analysis and report writing. ·Prepare and/or review PK and PK/PD sections of internal and external presentation of top-line PK results, Clinical Study Reports, PK summaries, IB’s, etc. ·Act as backup for PK/PD Leader and/or Manager when necessary at Clinical Team and other meetings. Qualifications : Education prefered: PhD in pharmaceutical, medical or biological sciences or a Master Degree in Biomedical or Pharmaceutical Science with experience in clinical development Sufficient experience in PK and pharmacology and a good understanding in PK/PD modeling and applied statistics; Experience in the pharmaceutical industry and/or regulatory environment is an added value
requirements and Critical Competencies: Minimum Technical Knowledge and Skills Fluent in written and spoken English Working knowledge of Microsoft suite of software products including Excel and Word Working knowledge of pharmacokinetic software is an added value (e.g., WinNonlin) Basic understanding of pharmacokinetics
Minimum Non-Technical Skills and Competencies Good oral and written communication skills Good sense of cultural sensitivity and diversity Good project management skills Good organizational skill with the ability to multi-task and prioritize assignments Ability and willingness to work in a cross-functional team environment Self motivated with the ability to work independently with minimal supervision Ability to work under pressure to meet deadlines
If you are interested in this position, please apply on our website : www.janssenpharmaceutica.be and search for requisition number : 0802111.
External website http://www.janssenpharmaceutica.be
Contact email address: mark.simone@pfizer.com - 1st Apr 2008 [1414]
The synergy between advanced knowledge management, quantitative drug development and advanced statistical study design are central to Pfizer’s drug development strategy. Pfizer has several challenging positions available globally. These positions are part of a continued company wide strategic recruitment effort to build on our existing strengths in applying modeling, simulation and innovative study design to optimize drug development.
Successful candidates will be hired at a level commensurate with their level of ability and expertise. The positions represent the spectrum of potential job roles and there is flexibility to accommodate individual skill sets and career aspirations.
Clinical Pharmacology Lead (Manager/Associate Director/Director)
Responsibilities: As a member of cross-functional project teams, responsible for development and execution of clinical pharmacokinetic (PK)/pharmacodynamic (PD) plans, including drug-drug and drug-disease interaction strategies, that will optimize doses, dosage regimens and study designs throughout clinical drug development. Responsible for design, analysis, interpretation and reporting of PK and PD studies in Phases 1 to 3. Integrate knowledge of PK, PD, patient characteristics and disease, (e.g., mechanism-based PD models and simulations incorporating such complexities as delayed response, disease progression or PD tolerance), to enhance decision-making and increase efficiency of drug development. Prepare Clinical Pharmacology elements of summary documents for regulatory submissions and contribute to the preparation and maintenance of Investigator Brochures and Investigational New Drug applications utilizing knowledge of relevant regulatory guidelines. Represent Clinical Pharmacology function in meetings with regulatory authorities. Specific duties will depend on extent of relevant industry experience.
Qualifications A doctorate degree in pharmaceutical sciences or related discipline, with post-graduate experience desirable. Compensation and title will be commensurate with training and prior experience. A strong theoretical understanding and demonstrated application of PK/PD principles, with experience using software such as WinNonlin, NONMEM, SAS, S-Plus/R or other related PK/PD applications desirable. Excellent oral and written communication skills, as well as demonstrated ability to work effectively in a team environment, are essential. The Clinical Pharmacology Lead positions will enhance the existing expertise and capacity currently available in New London, Connecticut, La Jolla, California and Sandwich, UK.
Pharmacometrician (Manager/Associate Director/Director)
Responsibilities The successful candidate will be part of a global Pharmacometrics Department working in partnership with therapeutically aligned multi-disciplinary clinical development teams of quantitative scientists. Candidates will be responsible for the use of innovative quantitative methods to integrate knowledge of pharmacokinetics (PK), pharmacodynamics (PD), patient characteristics and disease states to optimize doses, dosage regimens, study designs, clinical program designs and decision-making throughout clinical drug development. Responsibilities will include elements of the following: modeling of clinical trial data, including population PK and PK/PD; clinical trial simulations to support the design of clinical studies; quantitative evaluation of risk-benefit; meta-analyses of prior clinical trial results to provide an enhanced quantitative basis for decision-making; and development of new tools and methodologies that improve productivity. The successful candidate will also be responsible to mentor and train colleagues in the application of novel modeling and simulation methods to ensure Pfizer's position as a leader in model based drug development.
Qualifications A doctorate degree in pharmaceutical sciences, statistics or related discipline, with post-graduate experience desirable. Compensation and title will be commensurate with training and prior experience. The ideal candidate should have an extensive modeling and simulation skill set covering aspects of the following: design and analysis of PK and PD studies, proficiency in application of nonlinear mixed effects models, application of mechanistic PK-PD models, disease progression models, statistics and clinical trial simulations. Candidates must possess very good skills in the use of several specialized software such as NONMEM, SAS, S-Plus/R, Winbugs and/or TS2. Excellent oral and written communication skills, as well as demonstrated ability to work effectively in a team environment, are essential. The Pharmacometric positions will enhance the existing expertise and capacity currently available in New London, Connecticut, La Jolla, California and Sandwich, UK, as well as the newly created Pharmacometrics groups based in Seoul and Shanghai (the subject of a previous advertisement).
Please apply by going to www.Pfizer.com , click the Career tab in the lower left side, next click on Find a Career at Pfizer, then click on job opportunities, scroll down and put in 79513 for the Clinical Pharmacology Lead or 79507 for the Pharmacometrician position.
External website http://www.pfizer.com
Contact email address: inez.degreef-vandersandt@kinesis-pharma.com - 1st Apr 2008 [1413]
Senior Consultant Clinical Development and Pharmacokinetics
Kinesis Pharma BV is a consultancy firm and contract research organization for the pharmaceutical industry. Within the pharmaceutical industry, Kinesis Pharma BV works in a number of important areas of drug development, ranging from chemical-pharmaceutical, pre-clinical and clinical development to regulatory support. Our clients range from small biotechnology companies to large pharmaceutical companies. Kinesis Pharma is located in Breda and has customers both in the Netherlands and abroad. Kinesis is a dynamic and enthusiastic company with 45 employees.
Kinesis Pharma BV is currently looking for a Senior Consultant Clinical Development with extensive pharmacokinetic experience and with potential for a Director’s function. The Clinical Development department within Kinesis is involved in all clinical aspects of Phase I and II trials. The department consists of pharmacokineticists, trial managers and medical writers. Historically, the Clinical Development department has a strong background in pharmacokinetics, both non-compartmental analysis projects as well as exploratory PK/PD analysis projects.
The Senior Consultant Clinical Development will work closely with all team members and will have the end responsibility for the clinical pharmacokinetic projects. Furthermore, the candidate will be responsible for the scientific part of clinical trial protocols and regulatory documentation. The candidate manages all clinical activities associated with the client’s product development, including design of clinical trials, strategic clinical drug development and evaluation of scientific information. The product range of our clients encompasses small-molecule pharmaceuticals as well as biologicals. As Kinesis continues to grow, this function may lead into a Director’s position.
We are looking for a candidate with a PhD degree in pharmaceutical sciences and a minimum of 7 years experience in pharmaceutical industry. You have a strong background in pharmacokinetics, but have also in-depth knowledge of other aspects involved in the clinical development of a drug. Furthermore, you are able to build up good relationships with our clients and you have a strong sense of generating and developing business within your department. You have excellent communication and interpersonal skills and can work under strict timelines. Furthermore, management experience is preferred, as this function may become a Director’s position.
We offer a permanent contract with excellent primary and secondary terms of employment. In our organization you can acquire a high level of responsibility and independency, broaden your knowledge, experience and expertise and work in close collaboration with our other development departments. For more information you may send an e-mail to Lars.Bastiaanse@Kinesis-Pharma.com. Your letter of application and CV may also be sent by e-mail to this address or by regular mail to: L. Bastiaanse, Kinesis Pharma BV, Lage Mosten 29, 4822 NK Breda, The Netherlands.
External website http://www.kinesis-pharma.com
Contact email address: michael@westwoodwilshire.com - 31st Mar 2008 [1412]
Our client is one of the world's finest biopharmaceutical companies and has recently created opportunities at both the Associate Director and Director level in their New England and California offices.
As a member of cross-functional project teams, responsible for development and execution of clinical pharmacokinetic (PK)/pharmacodynamic (PD) plans, including drug-drug and drug-disease interaction strategies, that will optimize doses, dosage regimens and study designs throughout clinical drug development. Responsible for design, analysis, interpretation and reporting of PK and PD studies in Phases 1 to 3. Integrate knowledge of PK, PD, patient characteristics and disease, (e.g., mechanism-based PD models and simulations incorporating such complexities as delayed response, disease progression or PD tolerance), to enhance decision-making and increase efficiency of drug development. Prepare Clinical Pharmacology elements of summary documents for regulatory submissions and contribute to the preparation and maintenance of Investigator Brochures and Investigational New Drug applications utilizing knowledge of relevant regulatory guidelines. Represent Clinical Pharmacology function in meetings with regulatory authorities. Specific duties will depend on extent of relevant industry experience.
MINIMUM EDUCATION: A PhD degree or its equivalent in Pharmacokinetics, Pharmaceutics, Pharmacology or related field required, with post-graduate experience desirable.
MINIMUM WORK EXPERIENCE: The combination of education, training and experience will be considered in determining job title. A strong theoretical understanding and demonstrated application of PK/PD principles, with experience using WinNonlin, NONMEM, Adapt, S-Plus or other related PK/PD software applications desirable. Excellent oral and written communication skills, as well as demonstrated ability to work effectively in a team environment, are essential.
Contact email address: mike@pharmaes.com - 28th Mar 2008 [1411]
(***HIGH PRIORITY RETAINED SEARCH***) Our client, a worldwide leading global biotechnology company with a number of marketed products and an excellent pipeline is seeking a critical Clinical Pharmacology position due to their rapid growth and continued expansion.
DIRECTOR, CLINICAL PHARMACOLOGY
POSITION SUMMARY: Ensure effective, scientifically sound and consistent design and conduct of PK/PD data from clinical studies (Phase I-IV), including first in human, drug interaction, special population, food effect and other clinical pharmacology studies.
DUTIES AND RESPONSIBILITIES: The position represents the Clinical Pharmacology function on integrated project teams, will oversee a group of PK/PD Scientists and requires close collaboration with preclinical discovery and operations. Duties include analysis, interpretation and reporting of PK/PD data and results. This person will be required to provide scientific input for Clinical Protocols, clinical development plans, Investigator Brochures, and the Clinical Pharmacology section of INDs and NDAs and interact with contract research organizations (CROs). This individual will analyze PK/PD data from clinical studies (Phase I-IV), using NONMEM, WinNonlin, SPLUS or SAS, and will write reports for regulatory submissions. They will also be expected to independently develop clinical pharmacology analysis plans, evaluate clinical trial data using advanced exploratory data analyses techniques, and perform clinical trial simulations and apply novel pharmacometric principles to assigned studies. Supervision of department staff may also be required.
QUALIFICATIONS: Ph.D. and/or PharmD in Pharmaceutics, Pharmacokinetics, Pharmacology or related field. Minimum of 6-10 years Industry experience. Must have relevant experience and possess project work experience with all aspects of PK/PD using no compartmental and modeling techniques. PK/PD related software, such as WinNonlin, NONMEM, Adapt, or S-Plus. Familiarity with ICH, FDA and GCP guidelines governing clinical trial design and conduct. All candidates must have substantial knowledge of the requirements for the design, conduct, analysis, and report writing for regulatory submissions, in-depth understanding of drug metabolism and PK/PD principles. In addition, applicants must have a strong understanding of clinical trial simulation and integration of PK/PD modeling in drug development and have excellent verbal and written communication skills.
Extremely competitive base salary, bonus, stock options, Long Term Incentive Package, etc. Full company sponsored relocation package available.
Qualified candidates should confidentially submit their CV's to: Michael R. Aloisi (Mike) Principal/Director, Executive Search Operations Pharma ES, L.L.C. Pharmaceutical Executive Staffing Office: (914) 630-1109 Fax: (914) 381-0627 Mobile: (914) 406-5273 E-mail: mike@pharmaes.com
Contact email address: michael@westwoodwilshire.com - 28th Mar 2008 [1410]
As a member of cross-functional project teams, responsible for development and execution of clinical pharmacokinetic (PK)/pharmacodynamic (PD) plans, including drug-drug and drug-disease interaction strategies, that will optimize doses, dosage regimens and study designs throughout clinical drug development. Responsible for design, analysis, interpretation and reporting of PK and PD studies in Phases 1 to 3. Integrate knowledge of PK, PD, patient characteristics and disease, (e.g., mechanism-based PD models and simulations incorporating such complexities as delayed response, disease progression or PD tolerance), to enhance decision-making and increase efficiency of drug development. Prepare Clinical Pharmacology elements of summary documents for regulatory submissions and contribute to the preparation and maintenance of Investigator Brochures and Investigational New Drug applications utilizing knowledge of relevant regulatory guidelines. Represent Clinical Pharmacology function in meetings with regulatory authorities. Specific duties will depend on extent of relevant industry experience.
MINIMUM EDUCATION: A PhD degree or its equivalent in Pharmacokinetics, Pharmaceutics, Pharmacology or related field required, with post-graduate experience desirable.
MINIMUM WORK EXPERIENCE: The combination of education, training and experience will be considered in determining job title. A strong theoretical understanding and demonstrated application of PK/PD principles, with experience using WinNonlin, NONMEM, Adapt, S-Plus or other related PK/PD software applications desirable. Excellent oral and written communication skills, as well as demonstrated ability to work effectively in a team environment, are essential.
Interested candidates should contact Michael Barry at michael@westwoodwilshire.com or at 310.967.0945 x103 Westwood + Wilshire is the premier executive search firm in the Clinical Pharmacology world, placing senior level executives on a retained and contingency setting with some of the best Biotech and Bigpharma companies in the world. We currently have opportunities in CT, CA and IL.
External website http://www.westwoodwilshire.com
Contact email address: michael@westwoodwilshire.com - 28th Mar 2008 [1409]
As a member of cross-functional project teams, responsible for development and execution of clinical pharmacokinetic (PK)/pharmacodynamic (PD) plans, including drug-drug and drug-disease interaction strategies, that will optimize doses, dosage regimens and study designs throughout clinical drug development. Responsible for design, analysis, interpretation and reporting of PK and PD studies in Phases 1 to 3. Integrate knowledge of PK, PD, patient characteristics and disease, (e.g., mechanism-based PD models and simulations incorporating such complexities as delayed response, disease progression or PD tolerance), to enhance decision-making and increase efficiency of drug development. Prepare Clinical Pharmacology elements of summary documents for regulatory submissions and contribute to the preparation and maintenance of Investigator Brochures and Investigational New Drug applications utilizing knowledge of relevant regulatory guidelines. Represent Clinical Pharmacology function in meetings with regulatory authorities. Specific duties will depend on extent of relevant industry experience.
MINIMUM EDUCATION: A PhD degree or its equivalent in Pharmacokinetics, Pharmaceutics, Pharmacology or related field required, with post-graduate experience desirable.
MINIMUM WORK EXPERIENCE: The combination of education, training and experience will be considered in determining job title. A strong theoretical understanding and demonstrated application of PK/PD principles, with experience using WinNonlin, NONMEM, Adapt, S-Plus or other related PK/PD software applications desirable. Excellent oral and written communication skills, as well as demonstrated ability to work effectively in a team environment, are essential
Westwood + Wilshire is the premier executive search firm in the Clinical Pharmacology world, placing senior level executives on a retained and contingency setting with some of the best Biotech and Bigpharma companies in the world. We currently have opportunities in CT, CA and IL.
External website http://www.westwoodwilshire.com
Contact email address: thierry.lave@roche.com - 27th Mar 2008 [1408]
Modeling and simulation Scientist
Who we are F. Hoffmann-La Roche, a world leader in pharmaceuticals, has a reputation for successful, innovative drug development. The mission of the Preclinical Modeling and Simulation group at F. Hoffmann-La Roche Ltd. in Basel, Switzerland, is to predict the behavior of compounds in the body and to describe, in a quantitative way, dose-concentration-effect relationships. As part of the Preclinical group, our responsibilities cover a wide range : from supporting the drug discovery groups in their efforts to find new drug candidates to ensuring optimal support for the development of the compounds in our portfolio.
The position You will be responsible for conducting physiologically based PK modeling and simulation using mechanistically based pharmacokinetic/pharmacodynamic (PK/PD) models and state-of-the-art computer techniques to support drug candidate selection and development. With your strong expertise in the area of mechanistically based pharmacokinetics and advanced PK/PD methods, you will support drug discovery and drug development projects of various therapeutic areas. Your responsibilities will include the development of new methods to address issues related to modeling and simulation. Publication and presentation of research findings is strongly encouraged.
Who you are You have an advanced degree (PhD or equivalent) in biomedical science with emphasis on mathematical modeling preferably in preclinical pharmacokinetics and pharmacology and you have good experience in a variety of PBPK and PK/PD modeling software. You have at least 3 years of industry or equivalent experiences and gained professional experience in designing, interpreting and reporting PBPK and PK/PD studies. You are fluent in English and ideally have a good command of a second language, preferably German or French.
Who to contact For further information, please call Dr. Th. Lavé on +41 61 688 8479 or +41 79 322 2509 (email: thierry.lave@roche.com) If you are interested in this position please apply online and attach your cv and diplomas.
External website http://careers.roche.com/wms/roche/index.php
Contact email address: telder@greylock-recruting.com - 26th Mar 2008 [1407]
DMPK Scientist
Seeking an experienced and Drug Metabolism Scientist to perform in-vitro and in-vivo metabolite profiling and metabolite identification of the drugs in development. Key Responsibilities: • Plan, conduct, and interpret in-vitro and in-vivo drug metabolism studies. • Metabolite profiling for radio labeled as well as non-radio labeled drug candidates in drug development stage. • Metabolite characterization by using novel spectroscopic techniques such as LC-MS/MS, NMR etc. • Summarize and discuss the study results in interdepartmental group meetings. • Write reports for submission to regulatory authorities • Participate in discussion on multidisciplinary drug development teams • Collaborate with colleagues to design and implement overall drug development strategies. Minimum Requirements • Candidate must have a Ph.D. degree in organic chemistry, biochemistry, medicinal chemistry or a related field. • Minimum of 2-3 years of relevant postdoctoral or industrial experience. • Hands on experience on LC-MS instruments including triple quad, ion trap mass spectrometers and high resolution mass spectrometers. • Should be able to handle radio-labeled material. • In-depth understanding of biotransformation pathways, mechanism and techniques required for metabolite characterization. • Overall understanding of metabolism and pharmacokinetics and its application within a drug development setting. • Participate in broad-based interactions with internal/external collaborators • Ability to work in a time sensitive multiple project environmentExternal website http://www.greylock-recruiting.com
Contact email address: telder@greylock-recruting.com - 24th Mar 2008 [1406]
Associate Director/Director of Clinical Pharmacology and Pharmacometrics
Responsible for assisting with Clinical Pharmacology studies and to serve as the key person in the Clinical Pharmacology department for one of the company programs. This individual will analyze PK/PD data from clinical studies (Phase I-IV), using NONMEM, WinNonlin, SPLUS or SAS, and will write reports for regulatory submissions. This person will be required to provide scientific input for Clinical Protocols, clinical development plans, Investigator Brochures, and the Clinical Pharmacology section of INDs and NDAs and interact with contract research organizations (CROs). This individual will be expected to independently develop clinical pharmacology analysis plans, evaluate clinical trial data using advanced exploratory data analyses techniques, and perform clinical trial simulations and apply novel pharmacometric principles to assigned studies. Supervision of department staff may also be required. Qualified candidates will have a PhD in Pharmaceutics, Clinical Pharmacology, Biostatistics, Chemical Engineering or Mathematical Biology and applicable experience in the pharmaceutical industry or within a regulatory agency. Candidates with more experience will be considered for the Director position. All candidates must have substantial knowledge of the requirements for the design, conduct, analysis, and report writing for regulatory submissions, in-depth understanding of drug metabolism and PK/PD principles. In addition, applicants must have experience working with SPLUS or SAS and NONMEM, have an understanding of clinical trial simulation and integration of PK/PD modeling in drug development and have excellent verbal and written communication skills. Candidate with 2-3 years of industry experience are encouraged to apply as Scientist and Pharmacometrician level openings are online as well.External website http://www.greylock-recruiting.com
Contact email address: shahr@gene.com - 24th Mar 2008 [1405]
Head of Small Molecule PKPD
The department of Late Stage Pharmacokinetics and Pharmacodynamic Sciences at Genentech, Inc. is seeking a senior Ph.D. level Scientist Leader for our Small Molecule Clinical PK/PD workgroup. We need an individual who is driven to understand the PK and PD of exciting and novel drug candidates in the area of BioOncology, Immunology and Tissue Growth and Repair. This leader will be responsible for the development and recommendation of novel and state-of-the-art clinical PK study designs and clinical pharmacology strategies with the ultimate goal of determination of clinical dose/route/regimen for small molecules in clinical practice. This workgroup interacts with scientists across a broad range of functional areas including Chemistry, Biology, Preclinical Safety Assessment, Preclinical DMPK, Pharmaceutical Sciences, PD Biomarkers, Clinical Sciences, Biostatistics, Statistical Programming, Clinical Operations, PK/PD Modeling and Simulation; and this individual will serve as a liaison with these groups, enabling the workgroup. Responsibilities will include leading the scientific group, planning and review of study designs, analysis plans, and data analysis, assessment of study sites, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings. This individual will also be responsible for ensuring that all PK/PD analyses are of the highest quality and meet regulatory/ GXP guidelines. Additionally this individual will also be directly involved on initiatives, project teams and technical review committees in a leadership capacity, as well as provide mentoring and guidance for individuals within these teams.
REQUIREMENTS: A Ph.D. or equivalent in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences or related discipline with at least 10-15 years of experience. Strong leadership and managerial experiences are highly desirable. Familiarity and experience with Translational Drug Development with molecular targeted agents and the ability to guide in planning, organization, and analysis of experimental/quantitative data are essential. Experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of GXP and regulatory guidelines is highly desirable. Experience in forming or leading a drug development group or PK/PD group is required. The candidate must have excellent communication skills and the ability to work effectively on interdepartmental project teams. A proven track record of both Scientific achievement and Leadership is required.
Please contact Radhika Shah at 650-467-1431 or at Shahr@gene.com for further information on this opportunity.
Contact email address: shahr@gene.com - 24th Mar 2008 [1404]
The department of Pharmacokinetics and Pharmacodynamic Sciences at Genentech, Inc. is seeking a Ph.D. level Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the area of Oncology.
RESPONSIBILITIES: This individual will be responsible for clinical PK/PD activities for antibody drug conjugates, small molecules, and/or large molecules in late stage clinical development (Phase I-IV). This will include assessing and recommending dose/regimens for molecules in Phase I-IV (including new indication) by working in close partnership with Clinicians, Biostatisticians and project team members. Responsibilities will include planning and reviewing study designs, analysis plans, data analysis, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings. Additionally this individual will also be directly involved in leading project sub-teams and representing the function at cross-functional project teams.
REQUIREMENTS: Experience in drug development is preferred and experience with large and small molecule development is a plus. In addition, experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of GLP, GCP and regulatory guidelines is highly desirable. Leadership abilities are a plus. The candidate must have excellent communication skills and the ability to work effectively on interdepartmental project teams. Familiarity with standard modeling software (WinNonlin) and the ability to plan, organize, and analyze PK/PD data are essential.
EDUCATION: A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences or related discipline with at least 3 years of industry and/or related post-doctoral Clinical PK/PD and/or POP PK modeling experience are required.
If you are interested in applying for this role, please contact Radhika Shah at 650-467-1431 or at Shahr@gene.com
External website http://www.gene.com/careers
Contact email address: terry@tompkinsassociates.com - 13th Mar 2008 [1403]
Sr. Scientist II / III – Research Pharmacokinetics
Generous salary-range and great benefit package
Responsibilities * Carry out/direct preclinical pharmacokinetic experiments to ascertain biodistribution of therapeutic agent and its dependence on drug structure and/or formulation design * Conduct ocular bioavailability screening of compounds during hit–to-lead and lead-optimization stages * Correlate in vivo results with in vitro evaluations * Supervise personnel * Provide preclinical pharmacokinetic data in support of Discovery, Research, Drug Delivery, and project teams
Qualifications * Experience preparing INDs or NDAs * Pre-clinical PHARMACOKINETICS/drug metabolism experience * Doctorate (Ph.D.) degree within the scientific/technical discipline (preferably in Pharmacology, PHARMACOKINETICS, or Biochemistry) with two or more years of applicable experience
Contact email address: tma@staffing.net - 10th Mar 2008 [1402]
Research Scientist-Preclinical Development
Will design/implement studies that include genetic toxicology, safety pharmacology, toxicology, and toxicokinetics.
Small Mid-South NDA company with products on market. Very well funded. Major university city. Affordable housing. Competitive compensation and generous relocation program.
Contact email address: telder@greylock-recruiting.com - 10th Mar 2008 [1399]
Entry-Level Clinical PK Position
Natinally recognized leader in Clinical Pharmacokinetics and Pharmacometrics is seeking a talented, experienced, technically advanced clinical PK expert for entry level position. The skills required for this opening are in Population Pharmacokinetics and intermediate to advanced experience using NONMEM, SAS, ADAPT, and/or S-Plus. Recent and expectant PhD graduates are encouraged to apply as well as Post Doctoral candidates.External website http://www.greylock-recruiting.com
Contact email address: gemick@usachoice.net - 5th Mar 2008 [1398]
Job Description
Research Scientist: Project Leader - Large Molecule, Large Pharm
KEY OBJECTIVES/DELIVERABLES:
- Function as a drug disposition project leader in a multidisciplinary team environment with primary responsibility for the early preclinical development of antibodies and protein molecules.
- Integrate pharmacokinetics and PK/PD with discovery biology to define structure activity relationships to guide protein engineering strategies.
- Interact across groups, including other departments, regulatory agencies, and functional groups within drug disposition.
- Responsible for the design, conduct, interpretation and reporting of study results.
- Ph.D. in Chemistry, Biochemistry, Pharmacology, Biology or a related field in Pharmaceutical Sciences.
- Industry (pharma, biotech, CRO, etc.) experience with PK/ADME development of monoclonal antibodies, peptides/proteins or fusion proteins that you have obtained since receiving your Ph.D. degree.
- At least 2 years of industry experience in drug disposition or discovery related to biological therapeutics is preferred.
- Strong working knowledge of immunoassay methodology is desirable.
- Working knowledge of how PK/PD modeling can be applied to bioproduct development is desirable.
- Experience with drug development and knowledge of regulatory processes preferred.
- Prior experience working in an interdisciplinary team also preferred. The ideal candidate will have demonstrated ability to identify scientific issues and solve problems, directly in the laboratory and with partners in functional groups.
Contact email address: gemick@usachoice.net - 5th Mar 2008 [1397]
Study Director - ADME
This research facility in Southern Michigan exists to provide comprehensive preclinical and early clinical development research that meets the requirements of pharmaceutical, medical device, animal health, and chemical companies as well as governmental agencies as we partner together to bring safer, healthier products to the world.
Description: Responsibilities include the overall planning, conduct and financial oversight of non-clinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice. The Study Director primarily concentrates on internal and external communications, scientific expertise and regulatory compliance, and other essential functions, such as business development with a focus on customer service. The Study Director is expected to operate effectively, particularly with respect to client communication and scientific expertise, while developing and maintaining a viable client base.
Qualifications: Ph.D. in Drug Metabolism, Pharmacokinetics or a related field with 2-4 years of relevant experience in ADME/PK in a CRO or in the pharmaceutical/biotechnology industry or an M.S. in these fields and 3-5 years relevant experience in ADME/PK. Experience with drug metabolism concepts and conducting drug disposition studies with radiolabeled compounds in animal models is required. Experience with in vitro drug metabolism models will be considered. The successful candidate will also have experience with the regulatory requirements for ADME/PK studies, excellent organization and communication skills, flexibility and efficiency in handling multiple and shifting priorities. Familiarity with pharmacokinetics and graphics software such as WinNonLin, Prizm, and Sigma plot is preferred.
5th Mar 2008 [1396]
The synergy between advanced knowledge management, quantitative drug development and advanced statistical study design are central to Pfizer’s drug development strategy. Pfizer has several challenging positions available globally. These positions are part of a continued company wide strategic recruitment effort to build on our existing strengths in applying modeling, simulation and innovative study design to optimize drug development.
Successful candidates will be hired at a level commensurate with their level of ability and expertise. The positions represent the spectrum of potential job roles and there is flexibility to accommodate individual skill sets and career aspirations.
Group Head (n=1) and Group Member (n=5) Pharmacometrician positions based in Seoul (South Korea)
Group Head (n=1) and Group Member (n=5) Pharmacometrician positions based in Shanghai (China)
The newly created Pharmacometrics groups in Seoul and Shanghai will provide expertise and capacity as an integral part of Global Pharmacometrics (along with existing groups in New London, Connecticut; La Jolla, California and Sandwich, UK). The goal of Pharmacometrics is to improve drug development efficiency by quantitatively linking preclinical models of disease with clinical outcome through mechanistic approaches and applying these models prospectively in decision-making and advanced statistical study designs.
Responsibilities include the use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize dosing, study designs, clinical program designs and decision making. Responsibilities will include evaluating and applying new methodologies and techniques in PK/PD data analysis and /or advanced statistical study design that improve information quality and utility, and enhance productivity. The successful candidates will also be responsible for educating Development colleagues in the role of these methods.
In addition to the site-specific activities the successful candidates will forge collaborative relationships across all Pfizer sites, other subject matter specialists and groups external to the organization (leading academics etc.). The successful candidates will work with colleagues to ensure Pfizer's position as a leader in the use of quantitative approaches supporting drug development is maintained and enhanced.
The Group Head role in each country will be responsible for managing and leading the local group and will report to Peter Milligan, Global Head of Pharmacometrics.
Requirements: A doctorate degree in pharmaceutical sciences, statistics, medicine or related discipline. The ideal candidate should have an extensive modelling and simulation skill set covering aspects of the following: design and analysis of pharmacokinetic and pharmacodynamic studies, proficiency in application of nonlinear mixed effects models, application of mechanistic PK\PD models, disease progression modelling , meta-data models utilising internal and external sources, strong statistical skills, clinical trial design using principles of optimal design and trial simulation and understanding of Bayesian theory in decision theory/ trial design . Candidates must also posses’ very good skills in the use of several specialized software such as NONMEM, SAS, SPlus, Winbugs and/or TS2 as well as good written and oral communication skills. Candidates for the Head role should have previous management experience.
Please apply by going to www.Pfizer.com , click the Career tab in the lower left side, next click on Find a Career at Pfizer, then click on job opportunities, scroll down and put in 77792 for the Seoul Group Head or 78246 for the Shanghai Group Head.
Please note that there are also Pharmacometrician positions available that will report into the Group Heads. To apply follow the same instructions as above and put in 78449 for Pharmacometrician positions in Korea and 78453 for Pharmacometrician positions in Shanghai.
External website http://www.pfizer.com/careers
Contact email address: telder@greylock-recruiting.com - 4th Mar 2008 [1395]
Clinical Pharmacology Scientist/Sr. Scientist/Associate Director
Role Description:- Independently establishes and directs all aspects of clinical pharmacokinetic and pharmacodynamic study design and analysis as well as contributing to the planning of broader strategic objectives.
- Responsible for all clinical pharmacology study design with pharmacokinetic analysis and pharmacodynamic assessment of biological parameters of efficacy.
- Prepare clinical pharmacology study protocols, analysis plans and clinical reports.
- Oversee interactions with CROs providing sampling kits, conducting sample and PK analysis, report writing, and will include conducting audits of CRO.
- Provide presentations to clinical teams and internal program reviews.
- Operate within clinical teams.
- Participate on EDC teams focused on IND submission and give input on FIH dose estimation and biomarker development.
- Acts independently to determine methods and procedures on new assignments
- May direct the activities of other personnel or have direct supervisory responsibilities.
- Represents company in R&D efforts at national and international levels
- Takes leadership role in contributing to scientific literature and conferences and builds scientific respect within the company as reflected by these contributions
- Represents company in program presentations to both internal and external audiences including scientific conferences and partnerships/alliances
- Contributes to planning activities, ie department budgets, team goals and/or timelines
- Oversight of working relationships with external vendors and suppliers
- Able to act as a functional leader and participate on multiple product teams in a leadership role
- Ability to lead and develop others through constructive mentoring and positive influence
- Thought leader; able to rapidly work through issues and obstacles and generate creative solutions
- Ability to communicate across functions and take the lead in a matrix environment.
- PhD (PharmD) or equivalent in Pharmacokinetics, Pharmaceutics or Clinical Pharmacology with years experience.
- Extensive experience in clinical pharmacokinetics and pharmacodynamics applied to PK study design, analysis of results and model development using statistical packages such as WinNonLin, NONMEM and SAS.
- Experience with bioanalytical methods development and validation conducted by CROs.
- The candidate will have worked in a cross-functional matrix environment as part of clinical teams.
- A basic inderstanding of drug-drug interaction and metabolism is expected.
- Excellent communication skills both written and verbal are essential.
- Experience with regulatory affairs is a plus. Excellent organizational skills.
External website http://www.greylock-recruiting.com
Contact email address: telder@greylock-recruiting.com - 25th Feb 2008 [1394]
Associate Director DMPK
Responsibilities include:- Leading Biotransformation laboratory
- Be responsible for coordinating/monitoring Drug Metabolism studies
- Author ADME sections of regulatory submission documents
- Serve as a DMPK Representative on development project teams
- Ph.D. in pharmaceutical sciences, biology, chemistry or a related discipline with 10+ years of industrial experience.
- Core expertise in Biotransformation and techniques used for elucidation of metabolic pathways of small molecule drug candidates
- Broad-based knowledge in Drug Metabolism and Pharmacokinetics, and drug development process
- Experience as a DMPK project representative on product development teams.
- Record of peer-reviewed publications and contributions to regulatory submissions.
- Exceptional interpersonal, written and oral communication skills.
External website http://www.greylock-recruiting.com
Contact email address: terry@tompkinsassociates.com - 21st Feb 2008 [1392]
Pharmacokinetic Team Lead Salary range starts at 110K Permanent position in U.S.
Principle Duties:
- Provide effective, timely, efficient, and supportive leadership for direct reports and assigned contract personnel. Removes roadblocks, facilitates timely feedback, assesses progress toward timeline, provides technical expertise and direction if requested, and develops resources to maximize potential.
- Actively develops the management and scientific skills of Clinical Pharmacology direct reports and assigned contract personnel on an ongoing basis.
- Work cooperatively with Clinical Pharmacology (CP) personnel, non-departmental company personnel, and outside contractors to achieve Clinical Pharmacology Unit, PKDM department, R and D department, and company goals and objectives.
- Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of company lead candidates and post-marketed products.
- Prepares and maintains clinical pharmacology development plans and budgets for assigned projects and studies and ensures the team activities meet the aims, goals, and specified objectives.
- Provide support to senior staff in developing plans and study designs for effective and efficient conduct of Clinical Pharmacology studies.
- Submits and administers employee performance standards and actively develops personnel within the team.
- Provides timely and quality documents (i.e., protocols, clinical study reports (CSRs), technical reports (TRs) and Common Technical Documents (CTDs) to support global registrations on designated projects.
- Represents Clinical Pharmacology at various clinical meetings and project team meetings.
- Responsible for ensuring that the clinical and pharmacokinetic operations of the team are conducted in compliance with company’s PKDM standard practices, GCPs, SOPs, FDA and ICH guidances and regulations and company’s R&D objectives.
- Ensures that the team prepares timely and quality documents for regulatory submissions/responses for assigned project activities.
- Provide effective and timely mentoring and support for subordinates.
- Develop budget for assigned studies and provide these budgets to the CP unit head. Manage studies to stay within approved budget constraints.
- Experience in pharmacokinetic and pharmacodynamic data analysis and modeling and simulation.
- Familiarity with relevant Company SOPs and document management systems
- Good knowledge of GCP requirements.
- Familiarity with FDA and ICH regulatory guidance documents related to PK, PD, and clinical pharmacology.
- Excellent written and oral communication skills.
19th Feb 2008 [1390]
GlaxoSmithKline R&D (GSK) is committed to implementing a model-based approach to enhance efficiency and informativeness of drug development. We have an exciting opportunity within our Clinical Pharmacokinetics/Modelling and Simulation Department (CPKMS) in London area.
We are looking for a motivated individual with an established track record in effectively applying Clinical Pharmacology principles and Pharmacometrics methodologies to drug development. The role requires doctoral-level training in a Biomedical or Computational field. An analytical and inquisitive mind is essential for problem solving; and excellent team-work skills are necessary for collaborative work in our matrix environment.
In this role, you will be challenged to assist major decisions from candidate selection through commercialisation. You will be responsible for influencing the strategy and contents of clinical development plans. Mathematical and statistical modelling and simulation will be your primary tools to timely design, analyse and interpret clinical trials. You will have the opportunity to explore, learn and utilise state-of-the-art methodologies to help shape our question-based product development plans. With your extensive experience in Pharmacostatistics, you will also be advising colleagues on Modelling and Simulation methodologies.
As a member of our department that consists of enthusiastic and highly motivated scientists with varied background and a wide range of knowledge and skills, you can expect to make a difference to drug development.
At GSK, we value diversity, offer a competitive compensation package, and provide a supportive work environment with a variety of career development opportunities.
Interested individuals are encouraged to contact Dr Chao Chen (chao.c.chen@gsk.com) for details about the position.
Contact email address: andrej.skerjanec@novartis.com - 18th Feb 2008 [1389]
Company: Novartis AG, Oncology Business Unit/Development/Clinical Pharmacology Title: Fellow Clinical Pharmacokinetics Work Location: Basel/Switzerland or Florham Park, NJ, USA Job Description: The incumbent will be responsible for the clinical pharmacology component of selected new drug development and life cycle management programs of the Oncology Business Unit. He/she will represent clinical pharmacology expertise to both the pre-clinical and clinical areas in various team environments, in support of transitioning new chemical entities into the clinic, examining initial pharmacokinetics and pharmacodynamics of drug candidates in various populations and/or conditions, and studying their relationship. As a clinical team member, the candidate will work closely with Marketing, Regulatory Affairs, and Scientific and Technical line function to participate in the design of worldwide medical development plans for assigned projects, with emphasis on the principles and practice of clinical pharmacology and pharmacokinetics. He/she will coordinate the implementation and execution of this plan and support global strategies to develop new oncology business opportunities. He/she will support drug registration and enhance approvability and marketability of drug candidates, through innovative clinical pharmacology investigations and implementation of state-of-the-art methodologies.
Minimum requirements: Pharm.D. or Ph.D. with at least 7 years research experience in life sciences and who has had extensive experience in the conduct and evaluation of Clinical Pharmacology trials with demonstrated skills in pharmacokinetic assessments and interpretations including population PK analysis, PK/PD modeling evaluations, drug-drug interactions, bioequivalence, dosage form performance, and disease specific variables impacting PK and PD. Experience and knowledge of the drug development process are essential, including interaction with regulatory authorities. In addition, the candidate should also possess the following skills and qualities:
- Excellent communication (written/oral) and negotiation skills.
- Have the ability to influence others; a high energy level; be demanding of self.
- Have a questioning and challenging mind set, with a “what if” mentality; be intellectually bright and possess the ability to think creatively and “outside the box”.
- Has excellent project management skills and enjoys problem solving.
- Is comfortable operating independently but is also a keen team player and supportive of others; shows willingness to work within a matrix management system within and across departments.
- Can be flexible and excel in a dynamic environment.
Contact email address: andrej.skerjanec@novartis.com - 18th Feb 2008 [1388]
The DIRECTOR/TEAM LEADER will supervise a full service clinical pharmacology group supporting phase I-IV. Services will include design, and reporting on first in human, drug interactions, special populations and special safety studies. Reporting to the Head, Oncology Clinical Pharmacology, as part of the leadership team, you will work closely with therapeutic area leaders and give strategic input into the drug development process from a pharmacologic perspective. You will be involved in the selection of appropriate candidate compounds for clinical development. You will be expected to contribute to the design of first-in-human studies of both small molecules and biological agents (such as monoclonal antibodies). The Director/Team Leader will play a leading role in the design of phase I and IIa clinical trials, but will also be sought for his/her expertise in dose selection and dose confirmation for phase IIb trials. While it is expected that the Director/Team Leader will have less involvement in phase III and IV clinical trials, it is nevertheless anticipated that clinical pharmacology expertise will be needed in these later phases of clinical development as well. In this role, you will develop or supervise the development of clinical pharmacology sections for both clinical development plans and clinical protocols. As Director/Team Leader you will have responsibility for designing and analyzing the pharmacokinetic and pharmacodynamic components of clinical trials in all phases of development, for all oncology compounds. You will supervise the analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data from clinical trials. It will be your responsibility to provide appropriate interpretation of the PK/PD data and to incorporate that analysis into reports or sections of reports (e.g., INDs and NDAs) required for regulatory submissions to various health authorities (e.g., the FDA and EMEA) and to present and discuss these analyses in scientific/medical and regulatory forums. Similarly, you will provide the clinical pharmacology sections of clinical protocols, clinical study reports, and Investigator’s Brochures. The ideal candidate will have a PharmD or PhD with significant (7-10 yrs) industry experience. Candidates with less than 7 years of industry experience but with significant supplementary academic experience will be considered as well. The ideal candidate also
- Has the ability to lead, coach, and mentor a team of 4 – 6 associates
- Possesses excellent communication and negotiating skills
- Demonstrates cultural flexibility
- Has the ability to influence others; a high energy level; be demanding of self
- Has a questioning and challenging mind set, with a “what if” mentality and possess the ability to think creatively and "outside the box"
- Has excellent project management skills and enjoys problem solving
- Is comfortable operating independently but is also a keen team player and supportive of others; shows willingness to work within a matrix management system within and across departments
- Can be flexible and excel in a dynamic environment
Contact email address: mike@pharmaes.com - 13th Feb 2008 [1384]
Director/Sr. Director Clinical Pharmacokinetics (M.D.)
Our client, based in the Philly area and ranked in the top 15 biopharmaceutical companies worldwide and built on a strategic platform focused in select therapeutic areas is looking to fill a critical position in their Clinical Pharmacology Department. Reporting to the VP, Global Clinical Pharmacology, the Clinical Pharmacokinetics Director/Senior Director will be responsible for providing clinical PK/PD support and leadership to project teams and will provide clinical PK/PD expertise to support t he development, registration and commercialization of our products.
Responsibilities will include:
- Design clinical PK programs to support the development, registration and commercialization of products.
- Ensure programs comply with regulatory authority and legal requirements
- Ensure programs generate the information needed to conduct a thorough human risk assessment (appropriate for the stage of clinical development)
- Involve other staff and external specialists as necessary
- Provide support for publication strategies
- Provide support to Legal on patent and intellectual property issues
- Select on merit suitable Contract Research Organisations (CROs) and academic centers to carry out programs of work and to establish collaborations with key consultants
- Ensure appropriate contracts and procedures are in place to protect company’s intellectual property and reputation
- Ensure adequate resources and expertise are assigned to enable timely completion of the work
- Agree on detailed study protocols with contractors
- Monitor programs of work to ensure compliance with agreed protocols, quality standards and timelines
- Review data in a timely manner and amend protocols as necessary to achieve best outcome
- Ensure a high quality report, suitable for regulatory submission, is produced for each study
- Involve other internal and external specialists as necessary to interpret findings and assess relevance for use in man
- Provide clinical PK and human drug metabolism expertise to Project Teams and management across projects
- Immediately report any serious or unexpected adverse finding to the VP Clinical Pharmacology or, in his absence, to the SVP Clinical Research & Development.
- Provide the clinical pharmacokinetics and pharmacodynamics expertise and support required for Investigator Brochures, Clinical Trials Applications, Marketing Applications, regulatory meetings, and responses to regulatory questions.
- Participate in the writing, compilation and review of the dossier to agreed timelines.
- Identify potential in-licensing opportunities; review data packages, and present recommendations to management.
- Supervision and monitoring of external consultants and staff at Contract Research Organizations (CROs)
- An M.D. from an accredited college or university in clinical pharmacology, pharmaceutics, clinical pharmacokinetics or biopharmaceutics or closely related field and at least 10 years experience in the Pharmaceutical Industry working in clinical pharmacology, clinical pharmacokinetics or drug metabolism.
- A sound knowledge of clinical pharmacology and clinical pharmacokinetics. Expertise in PK/PD modeling and Population PK is also desirable
- A sound knowledge of drug regulatory authority biopharmaceutics and clinical pharmacology requirements to support the clinical development and marketing of new drug products
- A sound knowledge of GCP regulations and familiarity with GLP and GMP requirements
- A sound knowledge of the drug development process, and a detailed understanding of non-clinical and clinical DMPK processes
- A sound working knowledge of the cross-functional interfaces that are important for efficient drug development
- A sound working knowledge of regulatory documentation requirements
- Ability to present complex issues in oral and written form
- Ability to work independently, take initiative and complete tasks to deadlines
- Requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
Qualified candidates should submit CV to: Michael R. Aloisi Principal/Director, Executive Search Operations Pharma ES, L.L.C. Pharmaceutical Executive Staffing Office: (914) 630-1109 Fax: (914) 381-0627 Mobile: (914) 406-5273 E-mail: mike@pharmaes.com
Contact email address: telder@greylock-recruiting.com - 8th Feb 2008 [1381]
Principal Scientist In Vivo
Big Pharma Company Seeks: The individual will be active in practical laboratory work related to in vivo studies and pharmacokinetic data analysis for timely ADME_PK support of drug discovery. The individual will provide leadership in designing and carrying out in vivo experiments related to the investigation of the pharmaceutical properties of drug candidates including absorption, distribut