PK/PD and Other Jobs

External website http://www.oroxcell.com/

REF NO: LD154 - POSITION: Pharmacokinetics Assessor

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.

Purpose of Role: The Licensing Division is responsible for the quality, safety and efficacy evaluation of all applications for medicinal products to be authorised for the U.K. through national and E.U. Community procedures. To reflect the importance of pharmacokinetic data in the evaluation of clinical safety and efficacy and the increasing use of pharmacometrics in drug development we have a new post for a pharmacokineticist in the Division to integrate knowledge of pharmacokinetics into the assessment of safety and efficacy.

Key Responsibilities: Your scientific and professional expertise in pharmacokinetics will be vital in this challenging role, as you will work alongside clinical pharmacologists, clinicians and biostatisticians to evaluate the efficacy and clinical safety of a range of products including the latest new drugs, generic drugs and clinical trial products. You will provide advice on pharmacokinetic issues to colleagues within the Division and will review pharmacokinetic aspects of clinical trial data, preparing reports and recommendations which are highly influential in bringing new medicines to the market. You will need to interact with colleagues in other European regulatory agencies, the European Medicines Agency and to present your considerations to U.K. and European multi-disciplinary advisory committees. You will also be involved in the development of new regulatory guidelines and the provision of scientific advice on drug development programmes.

If you would like to apply for the above role or like more information please visit: http://cmsupgradepd/Aboutus/Workingforus/Currentjobvacancies/index.htm

External website http://www.mhra.gov.uk/Aboutus/Workingforus/Currentjobvacancies/CON140825

Director, Pharmacokinetics (discovery through translational) My client is seeking an experienced manager to lead projects in pharmacokinetics/pharmacodynamics for both small and large molecule compounds. Will assist in the design and interpretation of studies as well implement modeling/simulation techniques when applicable. Will contribute to the preparation of regulatory reports as necessary. This position is within a global organization and will have direct reports as well as matrix management. Will provide career development opportunities and manage a budget. Will ensure that project goals are met and also collaboratively interact with CRO partners. Additionally, will work with R&D senior managers to establish strategy for advancing relevant compounds into the clinical pipeline\\\\ Must maintain updated knowledge in literature relevant to therapeutic areas of research. Must have excellent written and verbal communication skills. This is an excellent leadership and growth opportunity. Please send resumes to broseberry@cartermackay.com or call 720-328-9526

Principal Investigator/Associate Director-Clinical PK--2 positions!! (one large molecule, one small molecule focus) My client has two open positions. The ideal candidate will have a PhD and a minimum of 5 years industry experience in pharmacokinetics and preclinical/clinical development of either small molecule or protein therapeutics. Must be able to design study protocols and work in a research team environment. Will possess strong scientific leadership skills. Additionally, must be able to utilize software such as WinNonLin, NONMEM, and preferably SAS/SPlus as well. These positions are senior level roles within an established pharmaceutical company. Excellent 401K, benefits, salary, relo, publication opportunity, and growth. For the large molecule position, should have knowledge in immunogenicity and biomarkers. If interested, please send resumes to broseberry@cartermackay.com or call 720-328-9526

Support candidate compounds from lead selection through development as part of preclinical candidate selection. Hands-on bench scientist role studying in-vitro metabolism and transporter interactions of compounds in development. Provide technical support or expertise related to in vitro ADME assays including: in vitro metabolism, cytochrome P-450 inhibition and reaction phenotyping assays. Conduct cytochrome P-450 reaction phenotyping experiments including correlation analysis, recombinant enzymes and specific cytochrome P-450 inhibitors Work closely with bioanalytical group members to characterize metabolic pathways and structural elucidation, when necessary, to support product labeling and also identify potential drug-drug interactions Provide support for identifying and implementing new strategies to enhance DMPK assays in discovery and development. Design and manage the conduct of outsourced pharmacokinetic and ADME studies by CROs, when needed. Participate on discovery and early development project teams

REQUIREMENTS: Ph.D.with 3-5 years pharmaceutical industry experience with in vitro drug metabolism. Good hands on experience in DMPK in drug development experience as well as a regulatory perspectives on drug-drug interactions, is required. Knowledge of integrating in vivo PK results with underlying transport or metabolic processes. Knowledge of drug metabolizing enzymology and kinetics. Demonstrated experience using concepts related to Cytochrome P450 enzymology and kinetics to conduct robust cytochrome P-450 reaction phenotyping experiments for compounds in development. Experience in the drug development process and project team interaction. Experience with one, or more, of the following areas: Cytochrome P-450 enzyme kinetics and in vitro assays, Biotransformation, Pharmacokinetics, Transporter regulation and function.

FOR MORE INFORMATION PLEASE CONTACT Cym Wasserman (203) 255-4698 contcsc@optonline.net Vice President Pharmaceutical Career Development CONTINENTAL CSC Fairfield Connecticut Suffern New York Philadelphia Pennsylvania

Job Description: Work as a member of the Preclinical Candidate Section team responsible primarily for supporting in-house programs in the characterization of small molecule drug physico-chemical, ADMET, & PK properties

• Independently conduct routine ADME screening assays for discovery compounds and those in early development; including but not limited to metabolic stability, plasma protein binding, cytotoxicity screening and cytochrome P-450 inhibition screening.
• Participate in the development and/or validation of new testing procedures and ADME techniques.
• Design and manage the conduct of outsourced early ADME screening studies by CROs

Hands-on experience with design, conduct and interpretation of in vitro ADME assays such as metabolic stability, cytochrome P450 inhibition, in vitro cytotoxicity, and plasma protein binding.

Ability to apply technical skills to conduct protein binding, assays for chemical and metabolic stability, and drug-drug interaction assays.

Ability to optimize and/or troubleshoot experimental procedures to fit the needs of specific therapeutic areas or compound classes.

Ability to integrate experimental results into the drug discovery and development process is required.

Expertise to conduct/validate non-routine experiments to solve compound-specific issues.

Excellent analytical/problem solving skills with the ability to think critically when evaluating results.

FOR MORE INFORMATION PLEASE CONTACT Cym Wasserman (203) 255-4698 contcsc@optonline.net Vice President Pharmaceutical Career Development CONTINENTAL CSC

Sr. Scientist, Pharmacology

Seeking a PhD with a background and knowledge in neuroscience pharmacology and immunology. Should also have a good understanding of GPCR function and signaling. Will be responsible for identifying and designing both in vivo and in vitro studies in a preclinical setting to be done at external sites, as well as selecting CRO vendors. Will present data and have publication opportunities, so strong written and verbal communication skills are essential. Will work in project teams with related disciplines and serve as the expert pharmacologist on novel compounds. Knowledge in nephrology is also helpful. This is a dynamic role where priorities will change rapidly...thus requiring an individual that is flexible and adaptable to a changing environment. Great growth opportunity withe exposure in a variety of therapeutic areas. salary, relo, benefits, 401K, etc. Please send resume to broseberry@cartermackay.com for more information

Job Description REQUIREMENTS:

• A Ph.D./Pharm.D. degree or have well demonstrated expertise/experiences in modeling and simulation/pharmacometrics or a related field.
• Hands-on experiences with NONMEM and other modeling and simulation software, e.g. WinNonlin, Trial Simulator, SAS, S-Plus/R, Monolix, Matlab, etc.
• A minimum of five-ten years\\\'experience in pharmaceutical industry, CRO or academia with a good understanding of the drug development process, and model-based drug development concept.
• Ability to present complex model information effectively and coherently to scientists of diverse background.
• A self-motivated, results driven person with good organization skills who can operate independently under broad direction.
• Strong analytical skills and the ability to think strategically and implement innovative ideas.
• Excellent oral and written communication skills, and interpersonal skill with the ability to work in a multidisciplinary team environment.
• Expected to interact globally with other Clinical pharmacokinetic and pharmacodynamic scientists, follow the harmonized processes, attend training sessions routinely, and to travel about 10-15% of the time.

• You are responsible for providing expert input into clinical development plans, individual study designs, data analyses and data interpretation of company’s development programs. You will be focused on one or two therapeutic areas to develop or expand (semi-mechanistic) disease models in this field. Working closely with Project Pharmacokineticists on the team and will join and work with the multi-disciplinary development teams as appropriate.
• Together with the Clinical Project Pharmacokineticist, you are responsible for the strategic planning of the modeling and simulation activities. You will focus mainly on the hands-on technical work in the analysis and interpretation of the data of clinical pharmacokinetic and pharmacodynamic studies, outcome studies etc. and performing clinical trial simulations to answer important development questions. The resultant deliverables will conform to appropriate internal and external (regulatory) guidelines such that rational development and registration of drug candidates can be rapidly achieved worldwide.
• You will also ensure an environment where performance and results are valued, individuals grow developmentally, and are provided with the opportunity to impact the organization by learning or developing new tools, techniques and processes. You will in-turn benefit from this environment as you look to develop your career within the company.
• Furthermore, the Modeling & Simulation Scientist will be responsible for evaluation and implementation of new analytical tools that will support in-silico drug development and will work in global teams to maintain and improve the pharmacometric infrastructure.

External website http://haallc.com/category/job-postings/

Director, Clinical PK, Modeling & Simulation – Biopharmaceutical R & D South San Francisco, CA - USA

Our client is a leading biopharmaceutical company, with a strong pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies and is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including: Respiratory Disease and Bacterial Infections.

With a number of strategic collaborations already in place, 2012 looks to be a very exciting and pivotal year for our client – not only because of a number of significant clinical catalysts but also because of the potential of their overall drug development pipeline.

The company’s Development pipeline has doubled over the last 2-3 years and in order to meet the company’s significant DMPK pipeline demands, our client needs to further strengthen and grow its capabilities (and overall DMPK expertise) with the appointment of an experienced and highly motivated Director – Clinical PK, Modeling and Simulation to support the company’s late stage small-molecule drug development projects.

In summary, the role will give the post-holder overall responsibility and accountability for a team of 2-3 individuals focused on Modeling and Simulation activities. Coupled with this, is the opportunity to influence, lead and define the overall vision, scientific strategy and future direction for Clinical PK, Modeling and Simulation efforts in relation to the company’s development projects.

To be considered for this role, you must have the following experience:

• Must possess a first degree in Life Sciences (or reacted) and a Ph.D. in Pharmaceutical Science, Pharmacokinetics, Pharmacology, Chemistry, Biochemistry, or related field
• Significant industry experience, ideally gained form the Pharmaceutical and / or Biotech industries (or related), specifically in a leadership role in Clinical Pharmacokinetics, Modeling and Simulation
• Experience in working optimally in a cross functional team and matrix environment
• Familiarity with IND-enabling studies and clinical drug development
• Demonstrated ability to independently design studies to investigate the Pharmacokinetics and PK / PD of compounds in clinical development
• Competent in the use of Pharmacokinetic and physiologically-based PK Modeling software tools such as WinNonLin, NONMEM, SAS and GastroPlus is an essential requirement
• Must possess a proven track-record in managing scientists involved in Clinical Pharmacokinetics and Modeling and Simulation activities and a strong publication record
• Strong written, presentation and verbal communication skills

Senior Scientist, Development DMPK – Biopharmaceutical R & D South San Francisco, CA - USA

Our client is a leading biopharmaceutical company, with a strong pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical companies and is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including: Respiratory Disease and Bacterial Infections.

With a number of strategic collaborations already in place, 2012 looks to be a very exciting and pivotal year for our client – not only because of a number of significant clinical catalysts but also because of the potential of their overall drug development pipeline.

As a core member of the DMPK team, the role will give the post-holder overall responsibility and accountability for several projects in Development. Using their broad base understanding and experience in DMPK (and drug development overall), the appointed candidate will be expected to use their scientific acumen to maximise the efficient delivery of the highest quality scientific data in support of the company’s Development projects – and, whilst ensuring that their function continues to be respected internally / externally as a strategic and integral component of the overall process of drug development.

To be considered for this role, you must have the following experience:

• Must possess a first degree in Life Sciences (or reacted) and a Ph.D. in Pharmaceutical Science, Pharmacokinetics, Pharmacology, Chemistry, Biochemistry, or related field
• Considerable industry experience, ideally gained form the Pharmaceutical and / or Biotech industries (or related), in Drug Metabolism and Pharmacokinetics, supporting Development projects
• Experience in working optimally in a cross functional team and matrix environment
• Familiarity with IND-enabling studies and clinical drug development
• Demonstrated ability to independently design studies to investigate the clinical pharmacokinetics, PK/PD, and drug metabolism of compounds in clinical development
• Familiarity with the conduct of studies to assess the potential for drug absorption, metabolic stability, protein binding, and drug-drug interactions
• Experienced in the use of Pharmacokinetic and physiologically-based PK Modeling software tools such as WinNonLin, SAS and GastroPlus – experience in the use of NONMEM would be seen as an advantage
• Familiarity with LC/MS/MS techniques
• Good written, presentation and verbal communication skills
• Strong publication record

Research Scientist, Metabolism/DDI
Preclinical Candidate Selection

Reports To:
Senior Director, PCS

Basic Function:
A hands-on member of the Preclinical Candidate Section (PCS) as a bench scientist, studying in vitro metabolism and transporter interactions of compounds from lead selection through development.

Essential Duties:

• Provide technical support or expertise related to in vitro ADME assays including: in vitro metabolism, cytochrome P-450 inhibition and reaction phenotyping assays, and others; conduct assays as needed.
• Conduct cytochrome P-450 reaction phenotyping experiments including correlation analysis, recombinant enzymes and specific cytochrome P-450 inhibitors
• Work group members to characterize metabolic pathways and structural elucidation, when necessary, to support product labeling and also identify potential drug-drug interactions
• Provide support for identification and implementing new strategies to enhance DMPK assays in discovery and development.
• Design and manage the conduct of outsourced pharmacokinetic and ADME studies by CROs, when needed.

Other Duties:

• Participate on discovery and early development project teams
• Expand the capabilities of the PCS group through the development and execution of new assays and ADMET techniques

Core Competencies:
Excellent analytical/problem solving skills with the ability to critically evaluate experimental data and integrate the results into the drug discovery and development process. Strong attention to detail is required. Outstanding organizational skills plus the ability to properly prioritize and multitask. Ability to work independently as well as function effectively within a team environment.

Knowledge of:
Knowledge of, and hands on experience with, the role of DMPK in drug development and regulatory perspectives on drug-drug interactions is required. Knowledge to integrate in vivo pharmacokinetic results with underlying transport or metabolic processes. Knowledge of drug metabolizing enzymology and kinetics. Prism software.

Education:
Ph.D. in Biochemistry, Pharmacology, Toxicology, or related scientific field

Experience:
3-5 years pharmaceutical industry experience with in vitro drug metabolism. Demonstrated experience using concepts related to Cytochrome P450 enzymology and kinetics to conduct robust cytochrome P-450 reaction phenotyping experiments for compounds in development. Experience in the drug development process and project team interaction. Experience with one, or more, of the following areas: Cytochrome P-450 enzyme kinetics and in vitro assays, Biotransformation, Pharmacokinetics, Transporter regulation and function.

To Apply
For prompt consideration for this position visit our career page at http://www.achillion.com/careers/locations and apply directly online.

External website http://www.achillion.com/careers/locations

Achillion Pharmaceuticals
Preclinical Candidate Selection
Research Associate / Senior Research Associate -ADME Screening

Reports To:
Sr. Director, PCS

Basic Function:
Work as a member of the Preclinical Candidate Section team responsible primarily for supporting in-house anti-infective programs in the characterization of small molecule drug physico-chemical, ADMET, & PK properties

Essential Duties:

• Independently conduct routine ADME screening assays for discovery compounds and those in early development; including but not limited to metabolic stability, plasma protein binding, cytotoxicity screening and cytochrome P-450 inhibition screening.
• Participate in the development and/or validation of new testing procedures and ADME techniques.
• Design and manage the conduct of outsourced early ADME screening studies by CROs
• Write up own reports and contribute to and review reports from group members.

Other Duties:
Other duties as assigned

Minimum Qualification Requirements
Core Competencies: Excellent analytical/problem solving skills with the ability to think critically when evaluating results. Strong attention to detail is necessary. Strong organizational skills and the ability to prioritize & multitask are required. Must be able to work independently under general supervision as well as function effectively within a team environment. Verbal and written presentation of experimental results and interpretation

Knowledge of:
Some knowledge of the drug discovery and development process and integration of the experimental results into the drug development program. General lab safety and maintenance procedures required. Familiarity with Microsoft Office products and Prism software is required.

Education:
B.S. / M.S. in a related scientific discipline.

Experience:
5+ years experience with ADME, Pharmacokinetic research in the pharmaceutical industry or medical research organization. Hands-on experience with design, conduct and interpretation of in vitro ADME assays such as metabolic stability, cytochrome P450 inhibition, in vitro cytotoxicity, and plasma protein binding. Additional experience with analytical instrumentation (HPLC or LC/MS-MS) and in vivo study conduct is a plus.

To Apply
visit our career page at http://www.achillion.com/careers/locations and apply directly online.

External website http://www.achillion.com/careers/locations

Director, Clinical Pharmacokinetics

This is an exciting opportunity to establish a newly created clinical PK group within a successful global CRO. Will be in charge of hiring staff and managing a departmental budget. This individual will serve as the \\\"go to\\\" person for all clinical PK activities and will lead cross functional communication efforts. Will also be expected to mentor senior PK staff in career development. Additionally, the successful candidate will be expected to:

• Identify and implement process improvement solutions.
• Communicate and present with clients and at professional symposia/seminars.
• Maintain current literature and technology knowledge in order to continually improve PK practices.

Clinical PK Modeler

My client is actively seeking a PK Modeler to conduct advanced PK/PD modeling and stochastic clinical trial simulations to ensure that the model-based drug development is properly implemented for late-stage discovery and clinical projects. The ideal candidate will collaborate with pharmacokineticists and statisticians, work as a partner in cross-functional project teams providing modeling and simulation support for clinical dose recommendation, optimal trial design, and rational development decision making. In addition, this person will lead, guide and mentor other pk folks and associate scientists in the PK organization.

Responsibilities: * Provide strategic input into the selection of drug candidates. Leverage expertise to address key clinical development questions. Responsible for the components in study designs and data interpretation. Contribute to the regulatory submission packages, and participate in regulatory meetings as appropriate. Interact with other pharmacometricians in the organization and monitor outsourced modeling activities to ensure quality of the work and timely delivery of the results. * Use innovative quantitative approaches to integrate knowledge of PK, PD, pharmacogenomics, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development decision making. Perform mechanistic PK/PD and disease modeling to establish dose-exposure-response relationship. Utilize published external data to enhance the knowledge of diseases and treatments, and to facilitate the development of internal drug candidates. * Actively promote firm as a biopharmaceutical leader in the utilization of quantitative model-based drug development approach. Support publication strategy. Present and report data in approved external conferences and scientific journals.

Qualifications: --PhD plus industry experience --Extensive experience in population modeling and stochastic clinical trial simulations using NONMEM. --Familiarity with statistical software package Splus, R or SAS. --Experience in writing PERL or UNIX/LINUX scripts is a plus. Prior experience in regulatory filings is highly desirable. --Great communication skills and ability to work in a cross-functional team environment; demonstrated experience and commitment to develop others.

Please contact Kerry Boehner of KOB Solutions, Inc. at 412-833-8710 or via email at kerry@kobsolutions.com for more information -- we look forward to working with you!

External website http://kobsolutionsinc.hiringhook.com/JobSeeker/Clinical_PKPD__Modeler_J01820407.aspx

Research Scientist-Clinical Pharmacology-West Coast My client is searching for a PhD with 2-5 years industry experience. Will be responsible for executing clinical PK/PD plans and strategies to achieve commercial goals and also meet regulatory requirements. Must also generate PK/PD study proposals and identify strenghts/weaknesses and formulate appropriate new strategies. This is a true Pk/PD drug development opportunity and the successful candidate will provide interpretation of study related projects, serve on project teams, author articles in peer reviewed journals, and contribute to regulatory submissions. Will assume a high level of responsibility in acheiving PK/PD goals and timelines. Excellent company, location, salary, benefits, and relo package provided. Please send resumes/CV\\\'s or questions to broseberry@cartermackay.com

Regeneron Pharmaceuticals (Tarrytown, NY) is hiring a Scientist, Preclinical Pharmacokinetics. PhD-level with 3-5 years experience, The individual will serve as a key contributor in the Preclinical Pharmacokinetics Group, providing pharmacokinetics expertise to project teams, toxicologists and other functional areas as required. This person will be responsible for protocol design/input for all Pharmacokinetics/ Toxicokinetics studies, evaluating data and authoring company reports. Requires experience in animal PK/TK studies, including protocol design & study conduct; Good understanding of both theoretical pharmacokinetics theory and practical application of those principles; Experience with PK software and conducting non-compartment & multi-compartment modeling; Staying current with latest industry development by reading scientific journals and attending national meetings; Maintains a compliant work environment by staying current with SOPs and being up-to-date with existing GLP guidelines; Experience with WinNonLin preferred. Position will be posted on Regeneron.com shortly.

External website https://sh.webhire.com/servlet/av/jd?ai=874&ji=2587383&sn=I

As part of the IMI DDMoRe project, Mango Solutions is looking to recruit a Pharmacometrics Technician. Applicants should have a degree or above in Modelling, Pharmacokinetics/Pharmacodynamics or related subjects, and have worked on PKPD studies. The applicant should have experience of: - NONMEM and FORTRAN - MPI and High Performance Computing - Grid technologies

The successful applicant will be responsible for systems analysis, installation, maintenance and development of modelling tools, infrastructure and environments.

Please submit application with cover letter and CV to recruit@mango-solutions.com

External website http://www.mango-solutions.com

As part of the IMI DDMoRe project, Mango Solutions is looking to recruit a Pharmacometrics Business Analyst. Applicants should have a degree or above in Modelling, Pharmacokinetics/Pharmacodynamics or related subjects, and have worked on PKPD studies. The applicant should have one year\\\'s experience of at least one of the following modelling tools: - NONMEM - Open/WinBugs - Monolix

And 3 or more years\\\' experience of one of the following general purpose tools - Matlab - R - S-PLUS - SAS The successful applicant will be responsible for business analysis and design of software that assists with model development, and be our \\\"expert user\\\". The role may also involve modelling consultancy engagements, and training.

Applications with cover letter and CV should be sent to recruit@mango-solutions.com

External website http://www.mango-solutions.com

Position in cellular pharmacokinetics

Today pharmacokinetic and metabolism groups objectives are to understand the mechanism of metabolic and transport processes (ADME proteins –enzymes and transporters) in order to predict cellular pharmacokinetics. Due to the complexity of the interplay between ADME proteins in the disposition of drug products, this first step has in fact become compulsory before extrapolating/predicting parameters at the organ or the entire organism level. It is also a necessary step in the understanding of potential Drug-Drug Interactions.

The position is based in Orleans (France) in vitro metabolism department generating and mastering all ADME in vitro tests from the screening to the registration phase but in close link with the pharmacokinetic modelling group (PBPK and PK-PD).

The eligible candidate should have a PhD degree in biology, biochemistry or bioinformatics with a good knowledge of the in vitro ADME tests in use in the industry and /or the mathematical description of the cellular mechanisms involved.

The project will include the development/improvement of in vitro tools in relation with drug development projects as well as the implementation of programming and modelling tools with the aim of combining optimally in vitro results and the mechanistic aspects involved in the disposition of drugs.

If you have a creative mind-set, a solid scientific background associated to strong communication skills for working with several departments you will find in this position a real opportunity for developing your capabilities

For more information, please contact us at the following address : cel@publival.com (ref 10326)

Passionate About Science
For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases.

The following opportunity exists in our South San Francisco, CA, headquarters:

Scientist- ED PKPD

Responsibilities:
The Early Development PKPD Department at Genentech is seeking an experienced scientist who is driven to understand the drug delivery kinetics of protein therapeutics and the pharmacokinetics and pharmacodynamics of novel drug candidates in the area of ophthalmology or neuroscience by using PK/PD translational models. This individual will be responsible for planning, conducting and reporting of PK/PD activities with protein therapeutics in drug delivery as well as in drug development. The successful candidate will have responsibilities for all relevant translational aspects bridging preclinical PK/PD information to patients. This includes developing and executing strategies to evaluate the delivery of protein therapeutics and characterizing the PK/PD behavior of novel drug candidates in therapeutic areas such as ophthalmology and/or neuroscience. The specifics of PK/PD as a highly interdisciplinary discipline require close effective partnerships among preclinical PK/PD scientist as well as with the drug delivery manufacturing groups, research scientist, clinical pharmacologist, clinicians, biostatisticians and project teams. Responsibilities will include planning and reviewing study designs, analysis plans, data analysis and interpretation of PK/PD as well as planning, conducting, presenting and reporting of PK/PD projects.

Requirements:
A PhD, Master’s degree or equivalent in Pharmacokinetics, Pharmaceutics, Pharmaceutical Sciences, Pharmacology or related discipline with relevant experience, preferably with experience in pharmaceutical, biotech or drug delivery industry and/or academia is required. A proven PK/PD track record in drug delivery and/or drug development either in industry and/or academia is required. The candidate must have knowledge about delivery of protein therapeutics especially in the ophthalmology and/or neuroscience.

Passionate About Our People
We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life.

Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. To apply for this job, visit https://roche.taleo.net/careersection/test/jobapply.ftl?lang=en&job=00383793&src=JB-11480.

Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. We are an equal opportunity employer.

External website http://https://roche.taleo.net/careersection/test/jobapply.ftl?lang=en&job=00383793&src=JB-11480

Passionate About Science
We’re passionate and rigorous about our science. For more than 30 years, Genentech has been at the forefront of the biotechnology industry, using innovative science to develop breakthrough medicines that improve the lives of people with serious or life-threatening diseases.

The following opportunity exists in our South San Francisco, CA, headquarters:

Associate Director/Director Early Development Pharmacokinetics and Pharmacodynamics

Responsibilities:
The Early Development Pharmacokinetic and Pharmacodynamics group is looking to fill a scientific leadership position in support of Discovery and Early Development activities for protein therapeutics. The candidate should be driven to understand the PK/PD of exciting and novel drug candidates in the area of BioOncology/Immunology/Neurology and Metabolism in a fast-paced, innovative and team oriented environment. This individual will be responsible for strategic and technical leadership of a large diverse group of excellent PK/PD, Metabolism and Modeling scientists working on translation of protein drug candidates from early stage research through entry into humans. Specific accountabilities include leading the group in the assessment and recommendation for dose/route/regimen and molecule selection for all protein therapeutics and working with basic Researchers, Pharmacologists, Bioanalytical Scientists, Toxicologists Clinicians, Biostatisticians, internal Modeling and Simulation Scientists and project teams. He/she will ensure all PK/PD analyses are of the highest quality and meet regulatory guidelines.

Requirements:
A PhD or equivalent in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences or related discipline with at least 8-10 years of post-doctoral experience is required. The candidate must be experienced and familiar with Translational Drug Development and the ability to use PK/PD data to help guide early drug development decisions. Experience in the preparation of regulatory applications (IND, NDA, BLA) and good knowledge of GLP/GCP and regulatory guidelines is highly desirable. He/she must have a proven track record of both Scientific Achievement and Leadership.

Passionate About Our People
We recognize that our people are our most important asset. It’s why we foster an inclusive environment that encourages diversity and offer competitive healthcare and benefits to help you bring the best to the business and to your personal life.

Join us as we continue to tackle medicine’s most challenging problems and live a life inspired. To apply for this job, visit https://roche.taleo.net/careersection/test/jobapply.ftl?lang=en&job=00381472&src=JB-11480.

Now a member of the Roche Group, Genentech has multiple medicines on the market for cancer and other serious illnesses. We are an equal opportunity employer.

External website http://https://roche.taleo.net/careersection/test/jobapply.ftl?lang=en&job=00381472&src=JB-11480

Greylock recruiting is seeking a Director, Clinical Development to oversee the development of proprietary company drug programs. Interacting with key members of the management team and reporting to the head of development, this position will serve to manage significant aspects of company drug development, particularly from lead clinical candidate selection through at least the early stages of clinical trials.

Specific responsibilities include: - Manage drug candidate programs from lead clinical candidate selection through clinical development; - Organize and manage IND-enabling outsourcing studies and, when needed, other outsourced functions (i.e., clinical trial data management); - Contribute to overall direction of clinical trials activities, including design, planning, and implementation; - Oversight in the planning, preparation, coordination and submission of IND packages and in responding to FDA queries, ensure timely preparation of scientifically valid submissions; - Identify, recruit and serve as liaison with leading oncology research institutions and investigators; - Provide scientific leadership on business development oncology program partnering efforts; - Oversee, manage, and direct Clinical Operations Manger and work closely with Director, CMC; - Provide administrative items such as budgeting, monitoring spending/progress, administration program meetings, etc.

Requirements: The candidate must have a Ph.D., MD, or PharmD, and the ideal candidate will possess a broad knowledge of oncology and have at least 5-10 years of experience in clinical drug development in the biotechnology or pharmaceutical industries, particularly in cancer drug development. The candidate should possess a strong track record of leading development efforts on clinical-stage drug candidates and in working with regulatory affairs to prepare, submit, and prosecute IND and other regulatory filings. The candidate must also possess excellent verbal and written communication skills.

External website http://www.greylock-recruiting.com/

Director, Associate Director, Pharmacokinetics and Biopharmaceutics

Overview: My client is a well established global pharma and generic company. We are looking for a a Director in Pharmacokinetic Studies with experience in generics and knowledge in biopharmaceutics. Will be responsible for set up, design and manage PK and CEP studies in conjunction with CRO partners. This position will also be responsible for ensuring that Bioequivalence programs and studies are properly designed, executed according to protocol, and maintain FDA guidelien adherence. Will also maintain a budget.

Additional Responsibilities:

• Manage all human pharmacokinetic (PK) and clinical endpoint (CEP) studies conducted by Contract Research Organizations (CROs)
• Perform literature searches and thoroughly evaluate the scientific/technical literature on specific drugs.
• Design scientifically sound PK and CEP studies that meet FDA requirements and R&D’s budgetary guidelines.
• Develop bioequivalence programs for ANDAs assigned and also be responsible for ANDA submission.
• Oversee all activities of a CRO on each assigned product from inception to completion
• Actively participate in the CRO selection
• Guide Analytical Research and Development (AR&D) efforts to develop in vitro dissolution methods predictive of in vivo performance, and assist the formulations group in identifying key aspects of the formulation or process which may be critical to bioequivalence.
• Evaluate preliminary PK and statistical data and interpret the results in the context of in vitro dissolution methods and critical formulation factors.
• Review and edit the final Clinical Study Reports (CSR) as required.

• MS, PharmD, or PhD, with broad background in biopharmaceutics, DMPK, IVIVC, etc.
• Knowledge of FDA guidelines.
• Capable of conducting independent research (both library and electronic) and evaluating available data.
• Proficient performing compartmental and noncompartmental analyses and modeling using WinNonlin and/or GastroPlus;
• Proficiency with MS Word, Excel, and Power Point.
• Working knowledge of SAS or experience with nonlinear mixed effect modeling (NONMEM) is a plus. Solid communication skills both writeen and verbal is essential

Greylock Recruiting is seeking a highly qualified Ph.D. level scientist in the area of Pharmacokinetics. The successful candidate will aid in the design, analysis, interpretation and reporting of pharmacokinetic and pharmacokinetic-pharmacodynamic results for both nonclinical and clinical studies. In addition, the successful candidate will be expected to participate on multidisciplinary drug discovery teams, where their role will be to plan, conduct and interpret in vitro and pre-clinical and clinical ADME studies. This opportunity is located within a “virtual company environment” so communication and experience with CRO’s as well as superb communication skills are of the utmost importance. This position will report to the Vice President of Pharmacology and Toxicology An in-depth understanding of all aspects of ADME with special emphasis on the application of pharmacokinetics in drug discovery and the ability to work in a team-based drug discovery/development environment is required The candidate must be able aid in the design of and manage both routine and mechanistic external animal PK/PD studies to drive drug discovery efforts Design and implementation of appropriate nonclinical and clinical modeling and simulation plans for drug development Knowledge and experience with the design of experiments to define PK-PD relationships and competency using non-compartmental techniques and pharmacokinetic modeling software (e.g., WinNonlin or equivalent) is required

Experience with nonclinical pharmacokinetic protocol design and experience working with CRO\\\'s is highly desired Provides complex clinical pharmacology input to clinical protocols, clinical development plans Prepare responses to inquiries from regulatory agencies, Investigator\\\'s Brochure, Clinical Pharmacology section of INDs, CTA\\\'s and/or NDAs Requirements and Qualifications: Candidates possessing a Ph.D. or MS in Pharmacokinetics or a closely related discipline with 5+ years of experience in drug metabolism and pharmacokinetics within a large pharma and / or biotech companies. Candidate should have a thorough knowledge of drug development of small molecules, including GLP studies; sufficient depth to aid in selection of drug candidates, as well as to interpret biologic results. Develops clinical pharmacology data analysis plans and informative sampling designs Design and implementation of appropriate nonclinical and clinical modeling and simulation plans for drug development Employs advanced nonlinear mixed effect modeling approaches in the analysis of PK/PD data Designs and conducts peer-reviewed clinical trial simulations Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions Demonstrates a good understanding of the requirements of the design, conduct, analysis and report writing for regulatory submissions

External website http://www.greylock-recruiting.com/

Director/Fellow--DMPK/Bioanalytical (GLP)--United States

Seeking a PhD with 7+ years of experience and a record of accomplishments to supervise and lead a group of BS/MS/PhD scientists. Will contribute to the advancement of projects and oversee studies both in house and at CRO\\\'s. Will be in charge of all bioanalytical studies associated with submissions to regulatory agencies.

Must be proficient in DMPK terminology and bioanalytical methodology, expecially in quantitative bioanalysis in GLP/GCP environment with LC/MS/MS. WIll also support PK/TK analysis for both clinical and nonclinical development studies. Must have excellent written and verbal communication skills, as well as strong leadership and the ability to prioritize and reporioritize as needed. please send resumes and questions to broseberry@cartermackay.com

PK/PD Modeler -- antibodies and biotherapeutics

My client seeks a Scientist to join their Translational Research department and conduct cutting-edge predictive modeling work. The ideal candidate will provide PK & PD modeling expertise to advance preclinical biological programs across many therapeutic areas. The ideal candidate will take on pharmacokinetic and pharmacodynamics model development and analysis, and partner with the experimental biologists to design studies for translation dose predictions. The ideal candidate will be both creative and innovative, passionate about improving the treatment paradigm of patients. Responsibilities: --Develop and analyze PK & PD models with data and perform simulated experiments with a predefined goal, in addition to new methodologies, protocols and test procedures that contribute to research goals and reflect expert knowledge. --Demonstrates clear understanding of R&D team goals and works effectively toward achieving them. --Evaluate and propose new technologies and concepts, as well as new experimental designs that contribute to research goals and reflect expert knowledge --Prepares clear technical reports, publications and oral presentations and communicates results in the form of reports and or presentations Requirements: --PhD or equivalent in PK & PD/Pharmacometrics or related mathematical modeling and simulation discipline. Two years post graduate PKPD modeling and simulation experience in the pharmaceutical or biotechnology industry. Strong expertise in biotherapeutic PKPD modeling and analysis --Familiarity with PK & PD modeling software: NONMEM, WinNonLin (preferably Phoenix), as well as Matlab & C language --Experience with preclinical PK & PD experimental design (e.g., mouse, nonhuman primates) --Strong communication skills and experience working in multi-disciplinary teams

Please forward your CV to Kerry Boehner at kerry@kobsolutions.com -- we look forward to working with you!

External website http://www.kobsolutions.com

Boston Based Company is seeking a highly qualified Ph.D. level scientist in the area of Pharmacokinetics. The successful candidate will aid in the design, analysis, interpretation and reporting of pharmacokinetic and pharmacokinetic-pharmacodynamic results for both nonclinical and clinical studies. In addition, the successful candidate will be expected to participate on multidisciplinary drug discovery teams, where their role will be to plan, conduct and interpret in vitro and pre-clinical and clinical ADME studies.

Key responsibilities: An in-depth understanding of all aspects of ADME with special emphasis on the application of pharmacokinetics in drug discovery and the ability to work in a team-based drug discovery/development environment is required.

The candidate must be able aid in the design of and manage both routine and mechanistic external animal PK/PD studies to drive drug discovery efforts.

Knowledge and experience with the design of experiments to define PK-PD relationships and competency using non-compartmental techniques and pharmacokinetic modeling software (e.g., WinNonlin or equivalent) is required.

Experience with nonclinical pharmacokinetic protocol design and experience working with CRO\\\'s is highly desired.

Provides complex clinical pharmacology input to clinical protocols, clinical development plans,

Prepare responses to inquiries from regulatory agencies, Investigator\\\'s Brochure, Clinical Pharmacology section of INDs, CTA\\\'s and/or NDAs.

The candidate must have excellent interpersonal skills, particularly oral and written communication skills and be able to work in a team environment.

Background: Candidates possessing a Ph.D. or MS in Pharmacokinetics or a closely related discipline with 5+ years of experience in drug metabolism and pharmacokinetics within a large pharma and / or biotech companies. Candidate should have a thorough knowledge of drug development of small molecules, including GLP studies; sufficient depth to aid in selection of drug candidates, as well as to interpret biologic results. Excellent written and oral communication skills required, and the ability to build and operate a multidisciplinary team.

External website http://www.greylock-recruiting.com

Postdoctoral Fellowship: Pharmacokinetic-pharmacodynamic modelling in the Cardiovascular Disease area Mölndal, Sweden

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. But we\\\'re more than one of the world\\\'s leading pharmaceutical companies. At AstraZeneca, we\\\'re proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

We offer an opportunity for an in vivo scientist with strong modelling and quantitative skills to work in a collaborative project between the DMPK (Drug Metabolism and Pharmacokinetics) and Bioscience departments. You will design and perform in vivo studies in animals, as well as develop quantitative models to capture the pharmacokinetic-pharmacodynamic (PK-PD) interactions. The aim is to provide an objective basis for correcting metabolic disease variables in preclinical animal models by optimizing pharmacological modulation of nutrient handling principles.

You will closely interact with scientists in multiple disciplines including DMPK and Bioscience and will be expected to regularly report your findings at internal research meetings and submit your work to peer reviewed international scientific journals.

• Technical proficiency, scientific creativity and independent thought
• Design and perform in vivo experiments in rodents
• Analyse pharmacokinetic and PD data arising from the in vivo experiments
• Develop mathematic models and perform parameter estimation to capture PK-PD relationships and test hypotheses related to optimization of treatment principles
• Regular oral presentations of findings at intra-departmental meetings
• Prepare manuscripts describing the work for submission to international peer reviewed journals
• Develop skills and knowledge in the field of substrate metabolism
• Work collaboratively with experts within DMPK, Bioscience and other disciplines

• Sound understanding of in vivo pharmacology
• Strong understanding of pharmacokinetic and pharmacodynamic modelling approaches including familiarity with modelling software (e.g. WinNonLin)
• Evidence of intensive hands-on experience with in vivo studies of rodents including small animal surgery and compound dosing
• Demonstrated ability to independently design, conduct, analyse data, write reports/manuscripts and orally present findings.
• Good networking and communication skills

More information Please contact: Johan Gabrielsson, +46 31 7064045 or Ann-Charlotte Egnell, +46 31 706 5284

Apply at www.astrazeneca.se/Career Closing date: November 6th 2011.

External website http://www.astrazeneca.se/Career

In vivo pharmacologist--Neurodegenerative Disease--united states

Seeking a PhD with post-doc or industry experience in developing in vivo models related to evaluate efficacy and tolerability of drug candidates in the area of Alzheimers disease. Should have experience in transgenic mouse models/efficacy models. Histology skills with astrocytes and glial cell isolation is highly desireable. This is an excellent opportunity and the candidate must possess solid written and verbal communication skills. Please send questions and resumes to broseberry@cartermackay.com

Sr. Scientist, Pharmacology-inflammatory and immunological diseases--United States

Seeking a PhD with 2+ years experience in hands on development of in vivo disease models to evaluate the efficacy, tolerability, and safety of drug candidates. Should have solid background in pharmacology as well as the biology and pathophysiology of diseases such as rheumatoid arthritis, lupus, and colitis. The ability to isolate primary cell populations of interest is also desireable. Must have excellent communication and presentation skills. Please send resumes or questions to broseberry@cartermackay.com

Bioanalytical Scientist position available US

Education/Years Experience Requires a B.S. degree in chemistry, biology or related field, 4+ years of relevant experience with a pharmaceutical company or CRO.

Requirements:

• Knowledge of LC-MS/MS equipment operation and data system software
• Ability to develop, validate and execute LC-MS/MS based assays
• Problem analysis and solving skills, including identification of alternative solutions, projecting the consequences of proposed actions, implement methods, procedures or techniques for resolutions
• Consult with project personnel on any compliance issues

• Prepares records and documents - standard preparations and analytical procedures used for sample preparation.
• Prepares standard solutions and reagents as per Protocols, SOPs or written instructions
• Conducts LC, MS and LC/MS analyses
• Preparation of Result Tables from sample analysis
• Preparation and review of protocols, validation and study reports
• Performs Method Validations
• Prepares and updates pertinent Standard Operating Procedures for management approval
• Performs the duties of a Study Director or Principal Investigator
• Works directly with internal and external clients. Ensures that management is informed of all progress and potential issues with client projects
• Responsible for laboratory equipment and ensures its qualification
• May present at conferences, scientific meetings, universities, Sponsor site with management approval

• Primary contact with customers to resolve concerns and address any routine questions with minimal supervision. Ensure management participation for non-routine issues.
• Prepare, review or update Standard Operating Procedures related to Bioanalytical operations.
• Ability to perform experiments required for successful conclusion of projects
• Maintain strict adherence to client confidentiality requirements

Principal Scientist, Clinical PK/pharmacology--West coast United states

My established pharmaceutical client is seeking an experienced clinical PK scientist with around 3-7 years industry experience. Should have experience in phase I and II protocol design, data analysis, and modeling/simulation. Must be proficient with NONMEM and WinNonLin. Will be expected to participate in cross functional teams and also contribute to regulatory filings as necessary. (IND, NDA, IB, etc). WIll present at meetings and also have solid publication opportunities. If interested, send resume or questions to broseberry@cartermackay.com or 720-328-9526.

Sales representative CRO ADME/PK Services LOCATION: California DESCRIPTION: California Clinical Research Organization is looking for a sales specialist with specific experience selling ADME/Tox/ services BASE:Bay area or San Diego or Vancouver. TERRITORY:US West of the Mississippi. ROLE: Involves qualifying, developing and closing prospects that require preclinical services such as PK studies, ADME studies, bioanalytical in vitro studies and in silico prediction studies. REQUIREMENTS: Advanced life sciences degree. You have been selling ADME/PK preclinical services for a CRO at least 3 years. Ideal person is from a CRO presently selling bioanalytical and toxicology services. Not a laboratory ADME/PK specialist with no related and specific matching sales background. COMPENSATION: A very competitive base salary plus commission as well as health and dental benefits and a 401(K) that is matched by the company.

Please contact Herbert Hess at hr@hessjobs.com 416 447 3355

External website http://www.hessjobs.com

Principal Clinical Pharmacologist

Competitive Package NRW Germany

You will join a leading, family-owned German corporation as it embarks on a major and forward-thinking transformation programme. A significant investment in R&D has resulted in the creation of a number of exciting opportunities for innovative and enthusiastic clinical development professionals.

Reporting to the Head of Clinical Pharmacology, you will be responsible for Clinical Pharmacology programmes for assigned new molecules within the analgesia and other therapeutic pipelines. This will include the design, set-up, supervision and reporting of clinical pharmacology studies, working in collaboration with internal and external partners, including Clinical Pharmacology Units worldwide. You will interact with regulatory authorities writing clinical pharmacology sections in the dossier and answering questions in connection with submission procedures. As a Principal Clinical Pharmacologist, you will provide scientific leadership and advice to less experienced staff within the department, overseeing activity across a range of early and late projects. You will also be the main link between project related and scientific activities of Clinical Pharmacologists.

Medically or scientifically qualified, you will bring to the role extensive experience in Clinical Pharmacology, ideally gained within the pharmaceutical industry. You will demonstrate outstanding expertise in all medical/scientific aspects of drug development and an appreciation of the challenges faced in developing products for therapeutic use. With strong leadership, communication and negotiation skills, you will demonstrate the ability to operate effectively in a fast-paced, rapidly-evolving matrix environment.

To apply, please e-mail your CV to 11317@theRSAgroup.com. Alternatively, call Penny Perry +44 (0)1707 282022 or email penny.perry@thersagroup.com

(Senior) Pharmacometrician

Competitive Package Germany

This role represents an exciting opportunity for an enthusiastic and forward-thinking Pharmacometrician to join a small but growing team and to genuinely shape its future direction –and the direction of Pharmacometrics within this organisation. Reporting to the Head of Pharmacometrics, you will play a key role in driving Modelling & Simulation strategies across all in-house drug development programmes. You will inform future study designs via PK/PD M&S to identify Optimal Doses and assess Dose Adjustment Strategies for special formulation and population: IV, Patch, TRF, Drug Combination, Elderly, Paediatrics, etc. You will also be responsible for the provision of simulation expertise into regulatory reports and regulatory defences and will partner day-to-day with multidisciplinary teams of scientists.

A PhD in modelling or a closely related discipline, you will bring to the role a strong academic background in Pharmacometrics. With considerable experience in pharmaceutical modelling & simulation, you will demonstrate an in-depth knowledge of exposure-response modelling and strategic thinking for developing drugs from pre-clinic to launch via submission to regulatory authorities. A strong team player, you will exhibit the enthusiasm, energy and drive to succeed in this rapidly changing organisation.

Call or email Penny Perry on : 0044 [0] 1707 282022 – penny.perry@thersagroup.com

Principal Scientist, Pharmacokinetics

Responsibilities include:

1. Serve as the department lead person for clinical pharmacokinetics in study and project teams.
2. Perform non-compartmental pharmacokinetic (PK) and pharmacodynamic (PD) data analysis using WinNonlin, to support compounds from translation research to phase III and life cycle drug development for IND/NDA registration..
3. Assist in the planning, implementing, interpreting and reporting of assigned Phase I to III PK and PK/PD studies.
4. Assist in the development of PK and PK/PD strategies to characterize compounds under drug development for global regulatory submission.
5. Provide input to clinical study designs and assist in the development of clinical study assessment plans, site selection, and PK samples logistics.
6. Conduct and report model based population-PK and population PK/PD analyses of cumulative preclinical and clinical data using NONMEM, S+ or R to describe exposure-response relationship in patient populations.
7. Assist in the development of the statistical analysis plan.
8. Scientific oversight of CROs with respect to PK and PK/PD tasks.

• Advanced degree (Pharm.D. or Ph.D.) in a relevant scientific discipline which includes pharmacokinetics and a minimum of 8+ years experience analyzing preclinical and clinical pharmacology studies.
• Must have comprehensive knowledge of PK and pharmacology concepts and hands-on experience in advanced PK/PD data analysis, ie. population and exposure-response analyses.
• Good understanding of the use of advanced PK and PK/PD principles for designing first-in-human studies and providing PK strategies for late phase registration studies.
• Working experience with WinNonlin„§. NONMEM, SAS, S+ and/or R.
• Good written and oral presentation skills, using Microsoft Word, Excel and PowerPoint.
• Good understanding of the use of advanced PK and PK/PD principles for designing first-in-human studies and providing PK strategies for late phase registration studies.
• Good team player, with the ability to work in a matrix, project-oriented environment
• Ability to organize and work simultaneously on multiple projects.
• Good knowledge of the drug development process.
• Knowledge and experience on clinical data base, PK/PD data compilation and manipulation with scripting softwares of SAS, R and/or Splus

External website http://www.celgene.com

Associate Director, DMPK--Northeast, US

The Asssociate Director will be responsible for directing preclinical metabolism, toxicology, and pharmacokinetic studies as well as evaluating new compounds nominated for clinical development. Will be working in a multidisciplinary drug development team. will be responsible for the Management and the design and preparation of pre-clinical metabolism, toxicology and pharmacokinetics strategies and study protocols, performing analysis of these studies. The Associate Director will be expected to provide strategic and operational direction, ensuring that studies are conducted in line with the appropriate guidelines/regulatory requirements. Will aslo assist in the preparation of preclinical study reports and summaries. May also provide feedback and direction for regulatory submissions preparation and review. Will work closely with clinical, biostatistics, data management, research and development and therapeutics areas to interpret results. Additionally the Associate Director wil make decisions impacting clinical pharmacology goals and clinical programs.

Requirements

PhD in Pharmacokinetics, Pharmacology or relevant discipline. Strong understanding of and experience in the design, execution and interpretation of strategies for ADMET and DMPK studies. Experience in IVIVC is highly desired, along with experience with Regulatory submissions to the FDA and other regulatory authorities is necessary. Familiarity with PK/PD modeling/simulation is also desired. 5-10 years industry experience is preferred.

Interested candidates send resume to broseberry@cartermackay.com

Director, Clinical Development: Company has developed a broad pipeline of development-stage assets. In addition, Company is currently developing two proprietary assets, including first-in-class drug working towards clinical testing and expects to initiate trials in with both candidates in early 2012.

Company is seeking a Director or Sr. Dir., Clinical Development to oversee the development of proprietary Company drug programs.. Interacting with key members of the management team and reporting to the head of development, this position will serve to manage significant aspects of Company’s drug development, particularly from lead clinical candidate selection through at least the early stages of clinical trials.

Specific responsibilities include:

- Manage drug candidate programs from lead clinical candidate selection through clinical development; - Organize and manage IND-enabling outsourcing studies and, when needed, other outsourced functions (i.e., clinical trial data management); - Contribute to overall direction of clinical trials activities, including design, planning, and implementation; - Oversight in the planning, preparation, coordination and submission of IND packages and in responding to FDA queries, ensure timely preparation of scientifically valid submissions; - Identify, recruit and serve as liaison with leading oncology research institutions and investigators; - Provide scientific leadership on business development oncology program partnering efforts; - Oversee, manage, and direct Clinical Operations Manger and work closely with Director, CMC; - Provide administrative items such as budgeting, monitoring spending/progress, administration program meetings, etc.

Requirements:

The candidate must have a Ph.D., MD, or PharmD, and the ideal candidate will possess a broad knowledge of oncology and have at least 5-10 years of experience in clinical drug development in the biotechnology or pharmaceutical industries, particularly in cancer drug development. The candidate should possess a strong track record of leading development efforts on clinical-stage drug candidates and in working with regulatory affairs to prepare, submit, and prosecute IND and other regulatory filings. The candidate must also possess excellent verbal and written communication skills.

External website http://www.greylock-recruiting.com

Translational/clinical PK Scientist position!! (East Coast--United States)

My clinet is seeking a creative and solid scientific individual to provide nonclinical and clinical pharmacokinetics guidance in the development of novel therapeutics -- up through Phase 2 and 3 clinical testing. This position will be within the clinical development organizatio and will supports multiple programs via participation on internal project working teams and serves as a liaison between the translational/clinical group and other functional areas such as tox, clin ops, etc. Will be responsible for the design and conduct of PK and clinical PK studies and conduct non-compartmental data analysis and pharmacokinetic modeling. The successful candidate will work with clinical study managers and also help to select external CRO\\\'s. Requirements: Experience with non-compartmental analysis required (WinNonLin); compartmental modeling and experience with NONMEM, population pharmacokinetic analyses, pharmacometric/PK-PD modeling is highly desired but not an absolute Proficiency in Phase 1 study design (including First in Human Studies) and familiarity with statistical approaches and programs for data analysis Strong scientific writing and presentation skills and current knowledge of FDA regulatory guidelines related to clinical pharmacology studies

A Pharm.D. or Ph.D. in pharmaceutical science (or other relevant program) plus 4 years clinical pharmacology experience in an industrial environment; Will also consider a BS/MS level candidate with 9+ years experience.

Interested candidates please send resumes to broseberry@cartermackay.com

My client seeks a Scientist to join their Translational Research department and conduct cutting-edge predictive modeling work. The ideal candidate will provide PK & PD modeling expertise to advance preclinical biological programs across many therapeutic areas. The ideal candidate will take on pharmacokinetic and pharmacodynamics model development and analysis, and partner with the experimental biologists to design studies for translation dose predictions. The ideal candidate will be both creative and innovative, passionate about improving the treatment paradigm of patients.

Responsibilities: --Develop and analyze PK & PD models with data and perform simulated experiments with a predefined goal, in addition to new methodologies, protocols and test procedures that contribute to research goals and reflect expert knowledge. --Demonstrates clear understanding of R&D team goals and works effectively toward achieving them. --Evaluate and propose new technologies and concepts, as well as new experimental designs that contribute to research goals and reflect expert knowledge --Prepares clear technical reports, publications and oral presentations and communicates results in the form of reports and or presentations

Requirements: --PhD and PKPD modeling and simulation experience in the pharmaceutical or biotechnology industry. Strong expertise in biotherapeutic PK PD modeling and analysis --Familiarity with PK & PD modeling software --Experience with preclinical PK & PD experimental design (e.g., mouse, nonhuman primates) --Strong communication skills and experience working in multi-disciplinary teams

Please contact Kerry Boehner of KOB Solutions, Inc. at 412-833-8710 or via email at kerry@kobsolutions.com -- we look forward to working with you!

External website http://kobsolutions.com/ourjobs.html

PK-PD Research Investigator

Job Description The selected candidate will be responsible for the pharmacokinetic (PK) and metabolism assessment of small and large (biological) molecules in support of drug discovery (preclinical) programs at Bristol-Myers Squibb, with an emphasis on modeling and simulations to better integrate pharmacokinetic and pharmacodynamic (PD) data in order to guide target validation, lead optimization, and candidate selection. The incumbent will represent the department at various working group and other relevant meetings, suggest and implement strategies and tactics to address PK-PD and ADME-related issues, and ultimately enable program decision-making focused on the selection and advancement of high-quality drug candidates. The individual will be expected to conduct necessary laboratory work at the bench and collaborate with a broad group of scientists in the metabolism and pharmacokinetics department, as well as scientists across various disciplines within the Research organization. The individual will also be expected to develop new tools and/or techniques in order to further enhance compound screening, characterization and risk assessment.

Position Requirement A doctorate degree in pharmacokinetics or related disciplines, with a minimum of 2 years of industrial experience. Hands-on experience and in-depth training in the area of pharmacokinetics is required. This includes, but not limited to, mechanistic PK-PD modeling, drug metabolism and transporter concepts and assays, enzyme kinetics, etc. Working knowledge and experience in transporter research is a plus. Strong work ethics, problem solving skills, and the ability to work independently in a goal-oriented and focused manner are essential in this job function. In addition, the candidate is expected to exhibit strong interpersonal and communication skills. The ability to work in a highly-matrixed environment is a prerequisite. Please send your resume to aberra.fura@bms.com

Strategic Professorship in Pharmacology or Clinical Pharmacology

If you might be interested in a well paid, professorial position with a broad job description in a nice city... we are looking for a suitable candidate for a tenured chair in Clinical Pharmacology, Flinders University Adelaide, South Australia.

The appointee will have a distinguished research profile and strong publication record in pharmacology or clinical pharmacology, together with a proven record of university level teaching.

Regards, Matt

External website http://www.flinders.edu.au/employment

Director, Clinical Pharmacokinetics and DMPK--Northeast US This is an exciting leadership opportunity within a global research leader!

The successful candidate will serve as department head and representative on all clinical pharmacology/pharmacokinetics and nonclinical development issues/projects. Will report in to the SVP and be responsible for generation of development plans encompassing preclinical through clinical development. Will assist the design and execution of both preclinical and clinical PK/PD studies and make stragegic decisions on moving programs forward.

Will also manage external collaborations and relevant sections of IND\'s, NDA\'s, BLA\'s, etc. Must have a good understanding of PK modeling principles and software such as WinNonLin and NONMEM. Will devise overall development plans and work closely with clin ops, regulatory, and other departments to assure that priorities across disciplines are appropriately communicated. Will also be responsible for selection of optimal dose/justification. experience with large and small molecule therapeutics is preferred.

Please send resumes to broseberry@cartermackay.com

ANNOUNCEMENT – PharMetrX Graduate Research Training Program

The PharMetrX Graduate Research Training Program: Pharmacometrics & Computational Disease Modelling is an interdisciplinary PhD program bridging pharmacy and mathematics. PharMetrX offers its graduate students a unique opportunity to experience research in drug development and optimising drug therapy jointly within academia and industry.

The PhD program is designed as a 3-year research program including a structured research training curriculum of advanced academic and industrial modules and a competitive research fellowship.

We are currently inviting applications to start the PharMetrX PhD program in March 2012. Deadline for applications: October 16th, 2011. For details see http://www.pharmacometrics.de.

PharMetrX is a joint program of the Martin-Luther-Universitaet Halle-Wittenberg, the Freie Universitaet Berlin and the Universitaet Potsdam, supported by five research-driven pharmaceutical companies. Charlotte Kloft & Wilhelm Huisinga (PharMetrX Steering Board)

External website http://www.pharmacometrics.de/

Associate Director/Director Clinical Pharmacology

RESPONSIBILITIES:

• Assists the Senior Director, Clinical Pharmacology for all clinical pharmacology aspects, including:
• Development of protocol outlines, protocols, pre-study, during study and post-study clinical activities
• PK/PD study design and analysis, PK/PD reports, and Executive Summaries for PK/PD studies.
• Population PK/PD design, analysis and reporting (Pharmacometrics).
• PK/PD modeling and simulation; Clinical trial modeling and simulation
• Clinical Pharmacology sections of GDCPs
• Relevant sections for regulatory filing of INDs and NDAs.
• Defense of regulatory submissions
• Pharmacogenomics and pharmacogenetic activities.
• Biopharmaceutics involving formulation development, dissolution testing, in vivo - in vitro correlations for pre- and post-NDA formulations.
• Management of outsourcing of design, analysis and reporting of PK/PD studies and pharmacometric studies, including modeling and simulation.
• Overseeing staff compliance with SOPs, policies, and procedures.
• Reviewing processes and procedures and recommending changes, where necessary
• Serving as project leader for project teams

REQUIREMENT:

• PhD/PharmD/MD in Pharmacokinetics, Clinical Pharmacology, Pharmacology, or a related area with a minimum of 6+ years of experience in these areas.
• Requires an in-depth knowledge of clinical pharmacology and pharmacometrics including pharmacokinetics, pharmacodynamics, drug metabolism, population analysis, PK/PD modeling and simulation.
• Good working knowledge of biopharmaceutics, bioanalytical chemistry, formulation development and drug development.
• Understanding of the pharmaceutical industry in general. Current awareness of the latest developments in clinical pharmacology.
• Must be able to apply scientific knowledge in the areas specified above to further the company’s products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively - Strong organization skills, have excellent verbal and written communication skills and the flexibility to react rapidly to changing situations/environment.
• Experience with writing regulatory sections and defending regulatory filings at the FDA a plus...will train.
• Experience with Pharmacogenomics a plus...will train.

FOR MORE INFORMATION PLEASE CONTACT Cym Wasserman (203) 255-4698 contcsc@optonline.net Vice President Pharmaceutical Career Development CONTINENTAL CSC Fairfield Connecticut Suffern New York Philadelphia Pennsylvania

This position focuses on aspects of drug metabolism and pharmacokinetics applicable to all of Repligen research and development programs. The successful candidate will be responsible for performing routine physicochemical characterization assays, (purity, solubility), in vitro ADME profiling assays (CYP inhibition, microsomal and hepatocyte stability assays), as well as pharmacokinetic sample preparation and quantitation. The position will also require a good understanding of metabolism as the candidate will also be involved in metabolite identification and quantitation studies. Good written and oral communication skills are a prerequisite. The candidate must be able to work under strict timelines while maintaining excellent data quality and records.

Duties and responsibilities

As described above, the Research Associate will assume the following responsibilities: -Routine testing of new compounds for purity, stability (chemical, cell, plasma), and solubility (HPLC proficiency required) -Evaluation of ADME parameters including CYP inhibition and metabolic stability using microsomes and/or hepatocyte -Outsourcing of ADME assays as required (for example, transporter assays, permeability determination) -Preparation and routine quantitation of pharmacokinetic samples from in vivo studies (LC/MS/MS experience a must) -Involvement in metabolite identification/quantitation studies. Together with supervisor, the RA will analyze samples from in vitro and in vivo experiments for presence of metabolites. New experiments will be run to confirm suspected species. -Data will be presented at team meetings

Qualifications/Requirements

Min B.S. with 3-5 yrs relevant experience in analytical chemistry (HPLC,LC/MS/MS), ADME, and/or drug metabolism. HPLC proficiency required, bioanalytical work using LC/MS/MS a must, experience with modern enzyme and cell-based assays desirable. Local candidates only; must be US citizen or Green Card holder

Please send cover letter with a resume in either MS Word or PDF format to: resumes@repligen.com

External website http://www.repligen.com/

Seeking industrial post-docs with experience in non-linear modeling and biotherapeutics.

PKPD Modeler, discovery

My client is seeking a PhD with 0-5 years industry experience. This individual will perform the following duties and Responsibilities: Will independently develop and analyze PKPD models with data and perform simulated experiments with a predefined goal. Develop new methodologies, protocols and/or test procedures that contribute to research goals and reflect expert knowledge. Will demonstrate a clear understanding of research or development team goals and work effectively toward achieving them; Has ability to participate as representative on multiple project teams and contribute to defining expertise-related aspects of overall program goals Will prepare technical reports, publications and oral presentations. Independently communicate results in the form of reports and or presentations; May deliver updates to senior level management in context of overall project goals

Required Education and Expertise:

• PhD or equivalent in PKPD/Pharmacometrics or related mathematical modeling and simulation discipline. Strong expertise in biotherapeutic PKPD modeling and analysis -- mechanistic models, PBPK, Systems Pharmacology a plus
• Excellent familiarity with most, if not all, PKPD modeling software: NONMEM, WinNonLin (preferably Phoenix)
• Experience with preclinical PKPD experimental design (e.g., mouse, nonhuman primates)
• Strong communication skills and experience working in multi-disciplinary teams For more information, please send resume to broseberry@cartermackay.com

Sr. Scientist/Associate Director PK/PD

Perform and interpret pharmacokinetic and immunogenicity analysis of samples from preclinical and clinical studies and ensure quality of data and regulatory compliance. Scientifically contribute to understanding the pharmacodynamic properties of candidate therapeutics in the preclinical and clinical settings. Interface with preclinical and clinical groups to establish project objectives and ensure they are achieved to support clinical development.

Major Duties and Responsibilities:

• Support project teams by performing PK data evaluation, analysis, interpretation, and reporting of pre-clinical studies and clinical trials
• Apply PK/PD modeling and simulation for selection of dose and dosing schedule for pre-clinical and toxicological studies.
• Provide the PK, PD and PK/PD-modeling strategy.
• Advise on, maintain, expand and optimize PK/scientific aspects in exploratory, Clinical Pharmacology and patient studies.
• Evaluate pre-clinical PK, PD, PK/PD and associated safety data to be used for application to the clinical development program.
• Liaise between Clinical Pharmacokinetics and Exploratory Development, CMC, Clinical Operations, as well as other R&D Areas Education: Candidates with a PhD (or equivalent) degree in pharmacokinetics, pharmacology, biopharmaceutics or related field

• Proficiency with WinNonlin or other commonly used PK and PK/PD software is essential
• Good verbal and written communication skills
• Excellent team working skills
• Good PK/PD modeling skills
• Familiarity with immunological techniques for biologics pharmacokinetics (PK) and immunogenicity assays such as HTRF, ELISA, ECL, MSD
• Understanding of bioanalytical guidances and regulations, such as Good Laboratory Practices
• Experience with writing/reviewing study reports and contributing to regulatory submissions Supervision: Ability to work independently. Should be able to multi-task and prioritize assignments. Able to work well with interdisciplinary teams representing pharmacokinetics and pharmacodynamics effectively on exploratory development project teams.

External website http://www.oncomed.com/

AstraZeneca (Waltham, MA) is looking for PK/PD modeling and simulation scientists.

Scientist/Sr. Scientist - DMPK - PK/PD

To view the job description, and to apply online, please visit:

http://bit.ly/rjP69p

Principal Scientist I - DMPK - PK/PD

To view the job description, and to apply online, please visit:

http://bit.ly/q5nlfZ

External website http://www.astrazeneca.candidatecare.com

DMPK Project Lead Biologics---F. Hoffmann La Roche, Basel

Location: Basel, Switzerland

The Position:

You will be part of a global team that applies pharmacokinetic and drug disposition expertise to the characterization of new biological entities for clinical development. You will work closely with preclinical and clinical pharmacologists, toxicologists, biopharmaceutical scientists and modeling and simulation experts in cross-functional drug development project teams and ADME experts within our function. In this position you will be responsible for the following duties:

• Act as responsible non-clinical DMPK project lead in multi-functional, local and international, research and early development and life-cycle (LCT) teams responsible for the evaluation and development of new biological entities (NBE)
• Integrate pharmacokinetics and bioanalytical data including immunogenicity assessment with information from other disciplines (e.g., toxicology, pharmacology, clinical, M&S).
• Develop a broad, innovative, science-based and forward-looking strategy for projects in regard to expected human pharmacokinetics and pharmacodynamics
• Prepare scientific assessments of non-clinical DMPK information on development compounds suitable for internal program review and regulatory submission (e.g. for IND, IB, CTA, Expert Report)

• PhD degree in pharmaceutical sciences, molecular biology or immunology with hands-on experience in pharmacokinetics and/or pharmacometrics
• Hands-on experience in data analysis (compartmental and non-compartmental) and prediction of human pharmacokinetics based on preclinical data
• A sound knowledge of PK/PD principles and hands-on experience with the most common modeling & simulation tools, such as WinNonlin, NONMEM, or Monolix
• Experience in interacting with Health Authorities and good knowledge in regulatory guidance (EMA and FDA)
• Excellent communication and organizational skills and able to handle multiple tasks in parallel Proficiency in English, other languages are of benefit

Apply online under http://careers.roche.com Job ID: 00379455

External website http://careers.roche.com/

PBPK modeling position in translational medicine-PK--NJ opportunity:

The successful candidate will provide early development projects with mechanistic understanding and data integration in assessing correlations between in-vitro and in-vivo (clinical) DMPK properties and the relationship between pharmacokinetics/toxicokinetics and pharmacodynamic responses. will apply modeling and simulation approaches to deliver benefit-risk based assessments of drug-drug interaction predictions and work in close collaboration with Discovery ADME, preclinical DMPK and Clinical Pharmacology to ensure fully integrated data analysis and interpretation and high quality decision making.

Requirements: Must have a minimum of a Master\\\'s Degree in with 7 years of relevant experience in a preclinical and/or clinical setting OR a PhD (preferred)in scientific discipline with 3 years of relevant Industrial experience in a preclinical and/or clinical setting. In depth knowledge of pharmacokinetics and hands-on experience with PBPK modeling tools is required. Understanding of current in vitro and in vivo DMPK models is highly desired. Strong scientific understanding of enzyme/transporter kinetics and in vitro to in vivo interpretation is required. Strong scientific curiosity, eagerness to learn and on top of recent literature in the area of translational DMPK is desired. The ability to work in a team/matrix environment is a must. Excellent oral and written communication skills as well as the ability to deliver high quality results under time pressure and understanding of preclinical drug discovery and development are required. Please send resume to broseberry@cartermackay.com

We are looking for a Clinical Pharmacologist with Strong PK/PD modeling Skills. This candidate will collaborate with multi disciplinary backgrounds providing technical input as the project rep for the Clin Pharmacology group. The candidate should need limited supervision. This person will develop, design and implement Pharmacology and M&S plans for Clinical Drug development. This person will have a strong understanding and experience of working with regulatory agency and submissions. Strong oral and written communication skills are needed.

Requirements: A PhD in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, or PharmD. Must have industry experience.

If interested please reply with your CV or Resume to jchapman@haallc.com

Director/Senior Director, DMPK -- Northeast US

Client is seeking an experienced leader to oversee all DMPK activities supporting the advancement of multi-therapeutic pipeline of compounds through preclinical, translation and into clinical development. The successful individual will have a proven track record of innovation and creativity, and a deep knowledge of new technologies and cutting-edge approaches to address in vivo pharmacology, drug metabolism and PK/PD issues. Candidates must also exhibit excellent oral and written communication skills, as this role requires the development of study protocols, reports, project and regulatory summaries, development plans and IND filings.

Responsibilities:

Establish and manage optimal ADME, PK and PK/PD strategies, including study design, implementation, timelines and budget, for a novel technology platform across multiple drug discovery programs; Supervise and mentor other scientists and create a positive, development-focused team environment; Work across disciplines to select, develop, and implement PK/PD models in collaboration with CROs and academic partners. Coordinate activities with internal bioanalytical and chemistry resources, and manage in vivo and other experiments conducted with Contract Research Organizations; Work closely with counterparts in clinical research and partnered discovery programs to translate preclinical results to clinical success; Author the pharmacokinetic, toxicokinetic, and ADME sections of briefing books and other regulatory submission documents;

Requirements:

PhD in Pharmacology, Biology, Pharmaceutical Sciences or a related field (e.g. PharmD, Biochemistry, or equivalent) with 10+ years of industry experience demonstrating significant expertise and in-depth knowledge in PK, absorption, distribution, metabolism, and excretion (ADME) of preclinical lead compounds and/or development candidates. A minimum of 10 years of pharmaceutical industry experience with respect to DMPK, including project management and briefing book/IB preparation, and IND/NDA submissions; Full understanding of PK/PD modeling and pharmacometrics, with the ability to quantitatively evaluate dose/PK/response in preclinical studies to inform the direction into the clinic; Working knowledge in understanding modeling and simulation using software such as SAS, NONMEM, Splus, R, Monolix, TS2 and Phoenix; A history of small biotech experience is desireable. Excellent communication and interpersonal skills

Please send CV and contact info to broseberry@cartermackay.com