PK/PD and Other Jobs

Contact email address: broseberry@cartermackay.com - 31st Aug 2010 [1940]

Pharmacokinetics Sr. Scientist--United States Preclinical PK/PD study design and data interpretation, including the development of mathematical models. Will work closely with preclinical and clinical pharmacologists as well as cross functional project teams. Must have experience with PK/PD software such as WinNonLin, Stella, and Kinetica. NONMEM would be a plus. Individuals with PBPK (physiologically based PK modeling) are desireable. Requirements include PhD in PK or related area with 1-4 years industry experience. RElo assistance is available. If interested please email CV or questions to broseberry@cartermackay.com

Contact email address: contcsc@optonline.net - 24th Aug 2010 [1939]

* Provide leadership and guidance to a team of highly trained scientists conducting clinical pharmacology studies in support of drug development programs. * Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies required to support projects and programs. * Provide effective management for the clinical pharmacology unit to include budget preparation, staffing requirements, personnel management, and operational conduct related to support. Lead, develop and maintain an effective, well-trained & cutting edge Clinical Pharmacology group with resources and skills needed to accomplish R&D development projects. * Design, and oversee the design, of project plans to accomplish successful filings and approvals of drugs across global jurisdictions in addition to the design of Clinical Pharmacology studies that are high scientific quality, that efficiently fulfill the requirements for product registration and approval globally. * Ensure that all studies supporting registrations comply with regulatory guidelines (ICH, FDA, EMEA, PMDA, etc.) for study selection, design, conduct, quality and documentation. * Work closely with the Project Team to ensure timely and accurate communication of results and provide necessary support and expertise to the development of new chemical entities. * Provide support of R&D project teams, including unit representation, communication/technical input, and adherence to timelines and authoring of regulatory documents. * Providing supervision, assistance, and/or mentorship to analysis, report writing, and model development conducted by other development scientists. * Scientific oversight of selected external CROs providing PK support for projects/studies.

Job Requirements * Ph.D. in Pharmacokinetics, Biopharmaceutics, Biostatistics, Engineering or other related pharmaceutical science * Experience factors related to prior scientific/technical achievements, increasingly responsible background in organization building of a scientific/technical function, and accomplishments in positions of leadership. * 10+ years of work experience in pharmaceutical or biotech post PhD. * Experience with multiple regulatory submissions and interactions. * Proven effective management skills. * Excellent oral and written communication skills. * Experience with software tools for PK analysis (WinNonlin, NONMEM, SPLUS, R, PLT Tools, etc.)

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

Contact email address: broseberry@cartermackay.com - 23rd Aug 2010 [1938]

Principal Scientist Will serve as a project representative on Global Development Teams, providing functional area expertise in the development programs and non-clinical/clinical study design involving PK and PK/PD. Effectively interface within the PKDM department and with external functions (such as Toxicology, Early Development, Clinical Development, Biostatistics, Regulatory affairs, and CMC). Identify and resolve PK/PD issues, assist /lead preparation of regulatory document sections, and represent the company as technical expert in interactions with regulatory authorities. The successful candidate will be responsible for implementing advanced modeling & simulation (M&S) techniques in drug development support, developing cutting edge M&S methodology, working collaboratively with other staff in cross functional team environment to ensure the design, analysis, and interpretation of pharmacokinetic/ pharmacodynamic (PK/PD) studies are optimized to investigate the ranges and sources of variability. Key responsibilities will include participating on cross-functional project teams, providing functional input, and leading the PK/PD analyses and interpretations for assigned projects. The incumbent will be responsible for completing and reporting analyses and results within preclinical and clinical studies using advanced PK/PD and M&S techniques, develop PK/PD program plan and conduct simulation analysis to support clinical trial design at various phases of drug development. The candidate will contribute to the preparation and maintenance of Investigator Brochures, IND/CTAs, and other summary documents for regulatory submissions. Basic Qualifications Ph. D. in Pharmacokinetics (PK), engineering, pharmacology, biostatistics or a Life Sciences field with 7+ years experience in the Biotechnology/Pharmaceutical Industry. Experience with PK and PK/PD for small molecule and/or protein therapeutics. Experience as PK/PD lead on development project teams, clinical protocol development, and PK/PD data analysis and interpretation. Experience in authoring regulatory documentation (IND, IMPD, CTX, CTD, MAA, etc), and interaction with regulatory authorities. Experience with theoretical aspects of PK/PD with respect to M&S and demonstrated application. Preferred Qualifications Candidate with good R&D experience in oncology therapeutics or inflammation area and previous work experience in pharmacometric (modeling & simulation) department is preferred. Demonstrated experience with M&S software (e. g. NONMEM, Adapt II, Pharsight Trial Simulator, SAS) . Interested candidates please contact broseberry@cartermackay.com or call 315-635-1227.

Contact email address: broseberry@cartermackay.com - 20th Aug 2010 [1937]

Sr. Pharmacologist II Northeast US client is seeking a pharmacologist with experience in various models of rheumatoid arthritis. (EX: collagen induced, antibody induced, adjuvant, etc.). Will focus on the discovery of both small and large molecules for the treatment of autoimmune diseases. The successful candidate will develop preclinical animal models to evaluate the efficacy of discovery drug candidates targeting RA. A background in Immunology and experience with rodent models of rheumatoid arthritis is required. . Will also need excellent oral & written communication skills. Requirements: PhD with 3-7 years of postdoctoral experience and solid publication record

Contact email address: broseberry@cartermackay.com - 19th Aug 2010 [1936]

Group Leader, preclinical bioanalysis Northeast US client is seeking a PhD with 3-7 years experience in bioanalysis and drug development. Expertise in quantifying compounds in biological matrices is required. Must be sound in the use of LC/MS/MS as well as the analysis of samples from in vitro ADME assays. The successful candidate will also supervise several junior scientists. This position requires experience in quantitation with both small and large molecules. Will perform both nonGLP and GLP work. For more information send CV to broseberry@cartermackay.com or call 315-635-1227

Contact email address: contcsc@optonline.net - 13th Aug 2010 [1935]

Senior/Principal Scientist, DMPK

Our client is looking for a scientist with PK/PD expertise to be part of the multidisciplinary small molecule drug discovery programs. The position ensures PK and PK/PD input for project teams from target validation to development candidate nomination. The candidate is also expected to lead the in vivo PK group.

Responsibilities:

Plan and execute PK studies and help design relevant behavioral/mechanistic studies with colleagues for enabling PK/PD modeling.
Utilize common approaches for human PK prediction and the application of human efficacious dose projections.
Represent DMPK in project teams and provide strategic scientific input in advancing compounds.
Lead the in vivo PK group of 2-3 scientists, PhD and MS.
Coach and mentor junior scientists to ensure highest quality scientific contributions to project teams.
Implement and maintain safety standards and internal animal welfare guidelines within the in vivo group.
Present original research findings in PK and/or PK/PD with authorship in peer-reviewed scientific publications.

Requirements:

PhD with 3+ years of industry experience with a degree in Pharmaceutical Sciences (or related discipline) or PharmD with Pharmacokinetics and PK/PD emphasis.
Proficiency in the theory and application of PK and PK/PD data modeling, analysis of small molecules.
Hands on experience in WinNonlin, IVIVC and/or SimCyp software applications.
Excellent written and oral communication skills, interpersonal/influencing skills, and ability to work in a continually changing environment.
Experience in effectively managing and supervising professionals with strong leadership skills.
Must be eligible to work in the United States.

Contact email address: contcsc@optonline.net - 13th Aug 2010 [1934]

Associate Director

The responsibility of Associate Director of Pharmacokinetics is to provide data formatting and analysis expertise as part of the global PK team. This would include responsibilities for developing and maintaining programs to meet needs for analysis and presentation of PK and PK/PD data for compound development. Additional responsibilities include reviewing plans, protocols and reports to meet regulatory requirements. Conducting PK and PK/PD data analysis. Reviewing bio-analytical plans and reports to ensure that the reports meet regulatory requirements Assisting in compilation of PK, and PK/PD analysis plans, dataset, and reports in accordance with Department standards Interacting with project teams/members, especially Clinical Operations, Biostatistics and Data Management functions Interpreting PK and PK/PD results to the team Assuring Clinical Pharmacology protocols have appropriate time points for sample collection, PK parameters to be estimated and bio-analytical methods and sample handling/processing procedures. Assuring on-time completion of PK analyses, topline results, and delivery to Teams Assuring on-time completion of bio-analysis (performed by CROs)/PK sections of Study Reports, relevant regulatory summaries. Managing the transfer of bio-analytical methods in support of Clinical Pharmacology and late phase clinical studies

REQUIREMENTS: Ph.D/ Pharm.D in Pharmaceutical sciences, or with PK training with minimum 5 years industry experience in Pre-clinical PK or Clinical PK. In depth knowledge of PK and drug development concepts. Will train in PKPD modeling. Must have WinNonlin and programming skills Must have demonstrated experience in providing PK support for projects across multiple therapeutic portfolios. Must have understanding and experience of regulatory requirements NDA,IND etc.

Contact email address: broseberry@cartermackay.com - 30th Jul 2010 [1933]

Director of Clinical PK and Pharmacology

The successful candidate will design clinical PK/pharmacology studies for small molecule therapeutics. Will be responsible for phase I-IV clinical drug development. Responsibilities will also include writing relevant sections of regulatory documents, interacting with senior management regarding PK proposals/reports, and working on multidisciplinary project teams.

Requirements: PhD in relevant discipline with 8-12 years or industry experience clinical pharmacology/PK.

Contact email address: recruitment@simcyp.com - 30th Jul 2010 [1932]

Pharmaceutical / Physchem Scientist

Closing Date for Applications: September 5th 2010 Line of Management: Reports to Principal Scientist Hours of Work: Mon – Fri 9.00am – 5.00pm (1hr lunch time) Holiday Entitlement: 25 days, plus statutory bank holidays Salary: Commensurate with experience, plus pension contribution, health scheme etc. Location: Sheffield (UK) Please visit www.simcyp.com for further information

Job Overview: We have an immediate opening for a Pharmaceutical / PhysChem Scientist who is keen to apply their skills to support the development of mechanistic models of drug absorption including the handling of formulations, the effects of excipients, dietary components etc. A good understanding is required of both the theoretical aspects of modelling solubility and dissolution rate and the practical issues related to their measurement. The main focus is expected to be upon oral drug absorption but may also include other routes such as the skin, lungs etc. The role will include collection of both drug-specific data needed to validate models as well as systems (physiological, anatomical etc) information as required. Any experience of M&S and/or the development and application of IVIVCs would be useful. The successful candidate will also provide support to colleagues in relation to the use of physico-chemical properties such as lipophilicity, membrane affinity, pKa etc required within the Simcyp simulator. The successful applicants will join an internationally recognised, multidisciplinary team in which they will be expected to take part in developing models and algorithms within the current framework of modelling and simulation guided by the Simcyp Consortium of clients.

Requirements: - Preferably a higher degree (or equivalent experience) in a relevant field: Pharmaceutics/Pharmacy/Formulation Technology/Physical Chemistry. - Demonstrable communication skills, as evident by history of presenting at scientific meetings and/or publication in peer-reviewed journals, with good interpersonal and organizational skills. - Working experience and knowledge of pharmaceutics including IVIVC, in vitro experiments. - Industrial experience/previous working knowledge of modelling and simulation tools would be advantageous. - Some understanding of a programming language such Fortran/C/C++/C# is preferable but not essential.

Applications: Please send your CV, covering letter (quoting ref: boom/PhysJul10) and names of two references to recruitment@simcyp.com, or post to: Recruitment, Simcyp Limited, The Blades Enterprise Centre, John Street, Sheffield, S2 4SU, United Kingdom

External website http://www.simcyp.com

Contact email address: dave.anderson2@pfizer.com - 28th Jul 2010 [1928]

Pfizer: Pharmacokinetics Dynamics & Metabolism (PDM) Principal Investigator (PI), Cambridge MA

As PDM representative to project teams, the PI will synthesize PDM knowledge, influence preclinical project plans and optimization of the biotherapeutic. The PI will co-lead a matrix team of PDM scientists to develop strategies. The PI will also advance the science and strategies for prosecuting biotherapeutic projects and influence external scientific and regulatory practices through publication and other interactions. Qualifications: - PhD with several years experience in discovery or development of biotherapeutics - Experience in studying coagulation disorders, metabolic disease, or replacement factors used in treatment of genetic or metabolic deficiencies. - Possesses PK, disposition, and immunogenicity risk knowledge specifically related to biotherapeutic modalities. - Broad understanding of immunological and other biotherapeutic bioanalytical assays. - General understanding of PK/PD modeling and its application to advance projects. - General understanding of protein chemistry/molecular biology/biochemistry. - Practical experience as project liaison and achieving results in a matrix environment. - Demonstrates ability to integrate data from multiple sources in to a rational understanding of distribution / clearance /etc. - Excellent presentation skills. Demonstrated through internal and external presentations. - Proven track record in the area of mentoring and coaching

to apply: http://posttrak.arbita.net/cgi-bin/PostTrak.cgi?RefCode=R5725184408549

At Pfizer, we\'ve long recognized that our colleagues are our most important asset. We value our colleagues, recognize their talent, encourage their growth and reward their performance. It\\\\\\\'s a terrific environment that enables people to contribute, to do their best, and to achieve their potential. Throughout our history, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees. When you choose a Pfizer career, we provide the resources to help you develop and succeed both in your career and your personal life. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life. Pfizer Inc: Working together for a healthier world

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act.

External website http://posttrak.arbita.net/cgi-bin/PostTrak.cgi?RefCode=R5725184408549

28th Jul 2010 [1927]

Senior ADME Scientist in Drug Discovery / Scientific Project Leader (temp. position)

Who we are

The headquarters in Basel is one of Roche’s largest sites, over 8,000 people from approximately 80 countries work at Roche Basel. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland – a great place to live and work.

The Position

You will be part of a global team that applies drug metabolism and pharmacokinetic expertise to the optimization of new chemical moieties and the selection of drug candidates for clinical development. You will work closely with pharmacologists, toxicologists, and chemists in cross-functional drug discovery project teams and ADME experts within our function. In this position you will be responsible for the following duties: * Represent the ADME function in drug discovery project teams * Develop and execute strategies for preclinical pharmacokinetic drug optimization with regards to expected human pharmacodynamics * Optimize safety relevant aspects of discovery molecules such as their drug-drug interaction potential with expected co-medications and the formation of chemically reactive metabolites * Assess the suitability of lead molecules for future clinical development This position is available on a temporary basis, initially for 3 years.

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies, and where a job title is not considered the final definition of who you are, but the starting point. * PhD degree in pharmaceutical sciences, chemistry or biology with at least 5 years postdoctoral hands-on experience in drug metabolism and pharmacokinetics * Hands-on experience in the prediction of human pharmacokinetics based on preclinical in vitro and in vivo data * A sound knowledge of PK/PD principles and hands-on experience with the most common modeling & simulation tools, such as WinNonlin, GastroPlus, or SymCyp * A sound understanding of preclinical in vitro & in vivo ADME test systems * Excellent communication and organizational skills and able to handle multiple tasks in parallel

Job ID No.: 22003

Contact Line: F. Schuler, Phone: +41 61 688 1547

The next step is yours. To apply online for this position visit www.careers.ch.

External website http://careers.roche.com/wms/extern/jobdetail.php?id=mS%2FJ5TNoA8MxtOIm4994dwgME84u12bilBt9i8i7726nx

27th Jul 2010 [1926]

Modeling and simulation Scientist (Basel)

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. 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 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. 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 gained professional experience in designing, interpreting and reporting PBPK and PK/PD studies preferably in the pharmaceutical industry. 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) To apply online for this position visit www.careers.roche.ch.

Contact email address: lmonahan@repligen.com - 26th Jul 2010 [1924]

Repligen is seeking a Senior Scientist or Associate Director (title commensurate with experience) for their Preclinical Development team. This unique position in a small company provides opportunity to be involved in a wide variety of bioanalytical activities related to drug development. The successful candidate will assume project team responsibilities related to the characterization and quantitation of lead molecules and clinical candidates in various media using chromatography and hyphenated methods. Proficiency with LC/MS/MS quantitation in research and development settings is required. Working knowledge of in vitro ADME assays is a must. Prior experience characterizing biologics preferred and previous experience managing internal and external resources is a plus.

Duties and responsibilities * Develop, characterize and validate analytical methods (mostly HPLC/UV, LC/MS, LC/MS/MS) for quantifying compounds in various media, including biological matrices, following GLP guidelines when required * Generate high quality reports that may be used to support internal and external project evaluation as well as regulatory agency submissions * Routinely determine physico-chemical properties of new chemical entities, including purity, solubility and stability in various media and analyze samples from in vitro ADME assays * Assess proteins for metabolic or post-translational modification. * Supervise and mentor bioanalytical team members * Provide assistance and/or manage external bioanalytical resources for early and late stage research and development projects * Prepare and present development programs at internal and external meetings

Qualifications/Requirements PhD in Chemistry, Biochemistry, Pharmacology or equivalent. A minimum of five to seven years of experience in a research environment and at least three years of experience in drug development within a biopharmaceutical company setting with an emphasis on bioanalytical research and development; prior experience with GLP laboratory and documentation practices helpful; experience with metabolite identification techniques a plus; working knowledge of in vitro ADME a must; experience working with and managing outside resources.

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

External website http://www.repligen.com

Contact email address: contcsc@optonline.net - 26th Jul 2010 [1922]

Lead the clinical pharmacology development programs in full development and life cycle management, and to 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 including drug interaction, age and gender, renal and hepatic impairment, food effect, and ADME studies in healthy volunteers. Responsible for the creation and design of the Clinical Pharmacology plan in full development and life cycle management and contribute to the Clinical Pharmacology aspects in early clinical development. Responsible for the preparation of the Clinical Pharmacology components of regulatory submissions and responding to regulatory questions. Represent the department at the development matrix team level to ensure integration of the Clinical Pharmacology plan with the global development plan.

REQUIREMENTS: Ph.D./PharmD in pharmacology or pharmacokinetics 5+ years industry experience in Clinical Pharmacology/Clinical PK is required. Experience as 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. Demonstrated experience in preparing regulatory submissions, including full NDAs or significant sNDAs. Experience responding to regulatory questions related to pharmacokinetics and pharmacodynamics. Strong project management skills required.

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

Contact email address: switzerland.recruitment@roche.com - 26th Jul 2010 [1921]

Laboratory Head Pharmacokinetics and Distribution in eADME

Who we are

At Roche, 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity, and on seeing each other’s differences as an advantage. To innovate healthcare, Roche has ambitious plans to keep learning and growing – and is seeking people who have the same goals for themselves. The headquarters in Basel is one of Roche’s largest sites, over 8,000 people from approximately 80 countries work at Roche Basel. Favored by its geographic location in the heart of Europe, the Basel area is one of the most dynamic economic regions in Switzerland – a great place to live and work.

The Position

You will plan and coordinate preclinical ADME studies in close collaboration with DMPK Project Leads and functional partners in Pharmaceutical Sciences and Bioanalytics

You will supervise a group of animal experimenters to develop in-vivo methods according to the 3R principles

You will take over responsibility for animal permissions and collaborate with the Roche Animal Welfare Office

You will evaluate and report internal and external studies and prepare documents in support to regulatory submissions. For this you will use various software tools, especially Word, Acrobat®, and ToxKin®. Line report will be to the Head of Pharmacokinetics and Distribution Group

Who you are

PhD or University degree in Biology, or an equivalent qualification according to the Swiss animal protection ordinance

Three years of practical experience in the field of animal experiments or comparable previous education with in-depth knowledge of animal welfare and animal experimentation procedures

A solid understanding of and experience with pharmacokinetics and drug metabolism with emphasis on in-vivo experimentation and the design of mechanistic PK investigations

Excellent communication and coordination skills

Ability to cope with multiple tasks and to keep focus under pressure

Experience in scientific report writing

We are looking for a team player with scientific background and excellent organizational and computer skills. The applicant must be fluent in (spoken and written) English. Command in another language (German or French) would be an advantage. Experience in MS Office and preparation of complex (regulatory) documents is required

The next step is yours. To apply online for this position visit www.careers.roche.ch.

External website http://careers.roche.com/wms/extern/jobdetail.php?id=mS%2FJ5TNoA8MxtOIm49R4dwgME84u12bilBt9iMi7726nx

Contact email address: mike@pharmaes.com - 23rd Jul 2010 [1919]

Associate Director, Clinical Pharmacology & Exploratory Development

Premier global Pharmaceutical company (Midwest) with a number of marketed products and an excellent pipeline.

Responsibilities: 1.Provide Exploratory Medicine & Clinical Pharmacology expert input to the development strategy of Company compounds with a global company perspective. 2.Design and ensure delivery (through scientists and Clinical Pharmacology Operations) to core teams of effective early clinical development strategies up to and including Proof of Concept and later Clinical Pharmacology strategies. 3.Provide clinical, (medical) scientific input to Translational Science Plans. 4.Be actively involved in Translational Science discussions in particular Disease Areas in order to ensure availability of state-of-the art knowledge and experience in Translational Science for practical application in clinical development. 5.Provide clinical input to Exploratory Development Assessments to guarantee the safety of first dosing to man. 6.Be the Global Clinical Pharmacology Lead for novel in-house discovered or in-licensed compounds. This requires leading a cross functional team of 15 – 25 experts in toxicology, pharmacology, ADME, PK, MS, CP Ops.

Requirements: * Design at least 2-3 Exploratory Development or Clinical Pharmacology strategies per year. * Contribute to on average 3-5 Translational Science Plans on novel projects. * Provide (medical)/scientific contributions to 1-2 Exploratory Development Assessments for compounds proposed to be entered first to humans. * Contribute to on average at least 2-4 IB/IMPD/IND regulatory documentations. * Provide the (medical) scientific lead for a cross-functional team of 15 - 25 people (e.g. scientists from PK, Translational Science, Toxicologist) in the design and delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration. * Supervise at least 1-3 junior scientists on the delivery of strategies.

Required Qualifications: * Minimum MS or equivalent qualification in a bio-medical/science field required. MD or PhD desired. * Minimum of 5-7 years post-graduate experience, in pharmaceutical industry, preferably from another (major) Pharma Company with a general understanding of Drug Discovery and Development. In addition, the individual should have the following experiences. * Expert knowledge of disease biology and relevant clinical disease knowledge required to design early development strategies up to and including PoC. * Knowledge and proven development expertise in at least 3 therapeutic areas (Oncology/Immunology strongly desired).

Highly qualified and motivated leaders may submit their CV in strictest confidence to: Michael R. Aloisi Principal/Director, Executive Search Operations Pharma ES, L.L.C. Pharmaceutical Executive Staffing Office: (914) 630-1109 Cell: (914) 406-5273 Email: mike@pharmaes.com

22nd Jul 2010 [1918]

Senior Research Associate/Associate Scientist, in Vivo Pharmacology Department: Translational Pharmacology Location: Cambridge, MA

Description We are seeking a highly motivated scientist to join our in vivo pharmacology group which focuses on translational research of novel targeted cancer therapeutics. The successful candidate will join a dynamic team which focuses on utilizing innovative in vivo models tailored to molecular targets for the understanding of mechanisms of action, biomarker discoveries and rationale combinations. Areas of responsibilities include establishment and implementation of in vivo models, efficacy assessment, PK / efficacy PK / PD relationship studies, biomarker discovery and development, interaction and communication within the team and across teams of other disciplines.

Responsibilities Characterize and implement in vivo cancer models including subcutaneous and orthotopic models for assessing pharmacological effects of drug candidates. Carry out ex vivo pharmaco-dynamic studies tailored to the molecular target of interest. Perform histology, IHC and semi-quantification analysis using image analysis tools. Documentation, analysis and interpretation of experiments and presentation within a multidisciplinary project team. Strong commitment to collaboration and working within a project team.

Qualifications & Requirements The successful candidate should possess a BS or MS in biological sciences or related fields with 2+ years of experience in cancer models, Industry experience with oncology models is strongly preferred.

For more information, please visit the company\\\'s website at www.aveopharma.com. Please forward resumes to hr@aveopharma.com

External website http://www.aveopharma.com

Contact email address: broseberry@cartermackay.com - 19th Jul 2010 [1917]

Clinical Pharmacokineticist/Manager

Exciting opportunity for ambitious PhD with 2-5 years experience in clinical PK/PD. Will be responsible for design and execution of all clinical PK and pharmacology studies-,-including protocol development, CRO selection, study monitoring, and PK data interpretation/analysis. Will be responsible for clinical study reports and regulatory submissions. PK/PD modeling experience as well as knowledge of statistical/data management methods are highly desireable. Another advantage would be experience in clinical efficacy or safety trials. US Residents only. For more information, email your cv to broseberry@cartermackay.com or call 315-635-1227

Contact email address: kerry@kobsolutions.com - 19th Jul 2010 [1916]

My client seeks an experienced GLP Bioanalytical Scientist to join DMPK group and lead antibody-therapeutic pk and immunogenicity studies in a GxP protein bioanalytical laboratory. The ideal candidate will have MS/PhD degree plus 5-10+ years experience & will take on the following responsibilities:

--Build & manage lab group --Develop, optimize, validate and implement quantitative immunoassays, anti-drug antibody and neutralizing antibody assays in support of non-clinical and clinical studies according to GxP requirements --Manage and prioritize projects within the laboratory, and implement tactics for achieving overall project goals. --Establish and utilize a LIMS system for compliant control of sample tracking, calculation of assay results and transmission and storage of data according to regulatory requirements

Please contact Kerry Boehner of KOB Solutions at 412-833-8710 or via email at kerry@kobsolutions.com for more info.

8th Jul 2010 [1915]

PhD research fellowship: Pharmacometrics & Computational Disease Modelling

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 2011. Deadline for applications: October 16th, 2010. For details see http://www.pharmacometrics.de/

PharMetrX is a joint program of the Martin-Luther-Universitaet Halle-Wittenberg (pharmacy) and the Freie Universitaet Berlin (mathematics), supported by six research-driven pharmaceutical companies.

Charlotte Kloft & Wilhelm Huisinga (PharMetrX steering board)

External website http://www.pharmacometrics.de

Contact email address: broseberry@cartermackay.com - 8th Jul 2010 [1914]

DMPK Project Leader--East Coast US Pharmaceutical client is seeking an accomplished PhD with 6+ years industry experience in DMPK. Must have experience in lead optimization, deep project team involvment, and expertise in addressing in vitro and in vivo DMPK challenges. Must possess strong leadership abilities as well as written and verbal communication skills. Must also have demonstrated expertise in problem solving and applying DMPK concepts to drug discovery programs. For more info call or email: 315-635-1227 broseberry@cartermackay.com

Contact email address: broseberry@cartermackay.com - 29th Jun 2010 [1913]

Sr. Scientist, Pharmacokinetics Ph D or PharmD with 1-4 years experience in PK, pharmacology, or related area. Must have strong background in PK and metabolism, as well as understanding of bioanlaytical methods. Essential is the ability to do compartmental and noncompartmental modeling and simulation with WinNonLin. NONMEM would be a plus. SHould have experience in nonclinical and clinical research and be able to assist in regulatory document preparation. Good communication skills are essential. Experience working with both large and small molecules would be a plus.

Contact email address: broseberry@cartermackay.com - 25th Jun 2010 [1912]

Sr.Scientist, Biomarkers/Oncology I am looking for a PhD with experience in predictive biomarkers-omics profiling. The successful candidate will be part of a translational medicine group with the goal to help identify patients who are likely to respond to a new drug as well as identify the dose regimen for that drug. Must have solid knowledge in biomarker strategies, as well as communication skills. Office/computer based position with lots of exposure within the company and at meetings. The perfect candidate would be someone finishing up a post doc or perhaps someone with 2 years industry experience. For more info send resume to broseberry@cartermackay.com or call 315-635-1227

22nd Jun 2010 [1911]

The individual will have the responsibility to lead the clinical pharmacology development of Cardiovascular/Metabolic Diseases programs in full development and life cycle management, and to 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. Will manage the clinical pharmacology profiling for cardiovascular/metabolic diseases drugs, including drug interaction, age and gender, renal and hepatic impairment, food effect, and Absorption Distribution. Will be responsible for the creation and design of the Clinical Pharmacology plan in full development and life cycle management and 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, and to 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. The individual will represent the department at the development matrix team level to ensure integration of the Clinical Pharmacology plan with the global development plan.

Requirements: Ph.D. in pharmacology or pharmacokinetics or a PharmD with a clinical pharmacology research fellowship. A minimum of 5 years experience gained through direct industry experience in Clinical Pharmacology is required. 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 skills required.

Refer to Position# 1002082 ... and apply at www.bms.com

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

Contact email address: christopher.kohl@actelion.com - 22nd Jun 2010 [1910]

Modelling & Simulation Scientist (Nonclinical DMPK)

About the Company Actelion (www.actelion.com) is a biopharmaceutical company founded in 1997, headquartered in Allschwil/Basel, Switzerland. Today with about 2’000 people in 28 countries we focus on discovery, development and marketing of original, innovative drugs for highly unmet medical needs. Our successfully marketed compounds are Tracleer® and Ventavis® for the treatment of pulmonary arterial hypertension and Zavesca®, the only approved oral treatment for Gaucher disease. Actelion shares are traded as part of the blue-chip SMI® (Swiss Market Index) since 2008. Actelion combines the innovation, entrepreneurial spirit and flexibility of biotech with the financial, risk management, regulatory and commercial discipline of a large pharmaceutical company. We have ambitious plans to keep improving and growing – and are looking for people as innovative as ourselves.

Job Responsibilities Providing quantitative pharmacokinetic and pharmacodynamic modelling and simulation expertise to pre-clinical project and Life cycle teams Applying quantitative PK/PD modelling and simulation to inform pre-clinical candidate selection Being a champion and advocate for pharmacometrics within the company Analyzing, interpreting and reporting pharmacokinetic and pharmacodynamic data from pre-clinical studies Performing PK/PD simulations and predicting pre-clinical and clinical PK from nonclinical data as appropriate Collaborating, mentoring and guiding other DMPK team members with pharmacometric support on their projects Interacting cross-functionally with other departments including Medical Organization, Toxicology, Formulation and Discovery Preparing and/or reviewing PK, PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IND, NDA, IB and other regulatory documents) Actively preparing, reviewing and publishing scientific papers and abstracts Representing the DMPK line on project teams

Candidate Requirements PhD in relevant discipline (e.g. Quantitative Pharmacology, Pharmaceutical Sciences, Chemical Engineering) 2 to 3 years experience in Modelling and Simulation in the Pharmaceutical Industry or Contract Research Organisations Proficient in spoken and written English Strong understanding of pharmacokinetic and pharmacodynamic principles including PBPK Hands-on experience with modelling and simulation software packages (WinNonlin Phoenix, NonMEM, R, Splus) Experience with Gastroplus, SimCYP would be advantageous Must be a team player and great communicator.

What Actelion Offers A competitive salary and generous social benefits The possibility for development and advancement within a constantly growing company The innovative and stimulating atmosphere of a multicultural environment

The research facilities are located in Allschwil, Switzerland, a suburb of Basel close to the borders of France and Germany.

External website http://www.actelion.com/en/applicants/job-opportunities/current-vacancies.page?

Contact email address: kathleen.kopf@cchmc.org - 11th Jun 2010 [1909]

Department of Anesthesia and Division of Clinical Pharmacology Cincinnati Children’s Hospital Medical Center

Cincinnati Children’s Hospital Medical Center is presently seeking a scientist who has a Ph.D, PharmD, or MD with postdoctoral fellowship training in pharmacokinetics, pharmacogenetics, biopharmaceutics or a related field. The position will be a joint appointment between the Department of Anesthesia and the Division of Clinical Pharmacology. Faculty appointments are granted through the University of Cincinnati, College of Medicine in Anesthesia and level/rank will be commensurate with candidate’s experience.

This is a unique opportunity to be part of a community of scientists and clinicians working together in well-equipped and funded research space to improve drug therapeutics in children with a variety of diseases. The research effort will focus on the application of pharmacometric approaches as they relate to anesthetic and analgesic drug pharmacokinetics, pharmacodynamics and pharmacogenetics in the pediatric population. Specifically, an emphasis on the implementation of novel approaches to clinical trial simulation and disease progression modeling in the field of personalized anesthesia and analgesia. An individual will be encouraged to take a leadership role in PK/ PD modeling, as well as exploring opportunities for developing drug and metabolite measurements.

Cincinnati Children’s Hospital Medical Center currently ranks in the top three among all pediatric institutions and number two in NIH-funding among Children’s Hospitals. The Department of Anesthesia and the Division of Clinical Pharmacology are working together to bring personalized predictive medicine a reality to the pediatric population. We offer tremendous support to our physicians to ensure their professional growth and to enable them to effectively treat the children in their care. The successful candidate will receive a substantial start-up package and laboratory space as necessary.

Please send curriculum vitae, brief statement of research objectives, and contact information for three references to:

Dean Kurth, MD Anesthesiologist in Chief C/O: Kathleen Kopf, Physician Recruiter Cincinnati Children’s Hospital Medical Center 3333 Burnet Ave, MLC 15009 Cincinnati, OH 45229 kathleen.kopf@cchmc.org

Cincinnati Children’s Hospital Medical Center is an Affirmative Action/Equal Opportunity Institution. Women and Minorities are encouraged to apply.

Contact email address: broseberry@cartermackay.com - 19th May 2010 [1906]

Biotransformation Scientist, DMPK

Pharmaceutical client seeking a PhD in medicinal chemistry or organic chemistry with 5 or so years of industry experience in LC/MS/MS, (API 4000/5500 QTrap and Waters/Micromass Q-TOF), ADME screening, and medID/biotransformation. Must have solid understanding of metabolic pathways, IND enabling studies, and excellent communication skills. Hands on experience with microsomal stability and hepatocyte studies is required. Must be a US citizen as no sponsorship is offered. For more information, contact Brenda Roseberry at 315-635-1227 or send resume to broseberry@cartermackay.com

Contact email address: matthias.kruse@parexel.com - 19th May 2010 [1905]

PAREXEL is one of the leading CROs worldwide. Our Phase I-IV studies incorporate the full range of services from clinical study design to bioanalytics to peri-approval and post-marketing services, with an emphasis on First in Man and Proof of Concept studies.

The Early Phase division is seeking for a Principal PK Scientist (Director level) located in Europe (London or Berlin). Being part of the management team, key responsibilities include shaping, mentoring and directing a newly formed international team of PK Scientists with the aim to provide state-of-the-art clinical PK/PD services to our clients. With the increasing needs for services in that area we anticipate significant growth of the group over the next years.

Requirements are a strong expertise in pharmacokinetic analysis, modeling and simulations to provide full scope of PK/PD services for early drug development and to cross-functionally support the business with other divisions.

Profile:

* PhD, MD, PharmD level scientist with 5+ years of relevant experience in PK with proven track record

* 5+ years of experience in drug development in CRO or Pharma

* Management and leadership skills

* Team player, independent and motivated

* Experience in working in interdisciplinary and international groups is advantageous

Main responsibilities include:

* Represent the department in project teams and client meetings.

* Provide scientific advice to internal and external customers

* Analyze PK/PD in clinical studies, predict and simulate clinical PK/PD to guide and justify dosing and sampling schemes

* Prepare and review clinical documents (study protocols and reports, statistical analysis plans)

Please contact anke.hoecker@parexel.com for more information if you are interested in this position.

External website http://www.parexel.com/Careers/

Contact email address: recruitment@simcyp.com - 18th May 2010 [1904]

Research Assistant IV Drug Transporters -Drug Disposition

Closing Date for Applications: 22nd June 2010 Hours of Work: Mon ¡V Fri 9.00am ¡V 5.00pm (1hr Lunch time) Location: Sheffield (UK) Salary: subject to experience plus pension contribution, health scheme etc.

Job Overview: We have an immediate opening for a Research Assistant / Research Scientist with a good understanding of physicochemical properties of drugs, human physiology and biology, and how these factors may affect oral drug absorption and disposition. Simcyp, as a research-based company, provides an excellent opportunity for advancing the knowledge and skills of graduates in pharmacy, pharmacology, physiology and medicinal chemistry in an environment that is scientifically challenging yet focused on solving practical issues relevant to modern drug development. The successful applicant will join an internationally recognised, multidisciplinary team in which s/he will be expected to apply physiologically-based pharmacokinetic (PBPK) models within the current framework of in vitro-in vivo extrapolation(IVIVE) and systems biology. Specific responsibilities will include:

To critically review literature to obtain information relevant to specific projects such as transporter-mediated disposition ¡V this will involve evaluation, interpretation and integration of data by means of systematic reviews and associated meta-analyses;
Propagating your knowledge of in vitro systems to other members of the Science Team for the development of modules that require implementation into the Simcyp Simulator. Initially, the focus will be on in vitro assays for assessment of drug transporters.

Additional tasks will include:

Communicating the research outcome internally and externally, with the approval of the company, in the form of poster and podium presentations at scientific meetings and contribution to publications;
Gaining familiarity with the Simcyp Simulator and its modules with the aim of being able to interact with our existing clients and potential clients in the Pharmaceutical Industry. Essential requirements:
A graduate (BSc) or higher degree from a reputable university in medicinal chemistry, biopharmaceutics or other subjects relevant to ADME in drug development;
Hands-on experience (as part of a graduate project or industrial experience) with in vitro systems used for ADME screening, particularly those related to drug transporters, and a good understanding of environmental and biological variability;
A demonstrable knowledge of literature search techniques, data analysis and interpretation;
Good interpersonal, organizational, and communication skills

Please visit our website for further information Applications: Please send your CV, covering letter and names of two referees to recruitment@simcyp.com, or post to (quoting ref- resT/pharm/May): Recruitment Simcyp Limited, The Blades Enterprise Centre John Street, Sheffield, S2 4SU, UK

External website http://www.simcyp.com

Contact email address: contcsc@optonline.net - 7th May 2010 [1900]

Sr. Director/Director Clinical Pharmacology

Responsibilities:

Provide appropriate clinical pharmacology input on project teams and clinical pharmacology expertise and leadership to a project.
Provide support to Therapeutic Research Units covering Neuroscience, Cardiovascular Medicine, and Oncology.
Ensure planning and direction of clinical pharmacology components on the clinical project level (including clinical development plan) and studies (including synopsis preparation, clinical phase oversight, reporting).
Ensure clinical pharmacology leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensure overall scientific accountability for the designated studies.
Ensure appropriate dose-finding strategies during clinical drug development
Ensure appropriate design and implementation of a clinical modeling and simulation plan.
Ensure use of innovative analytical methods to optimize doses, dosage regimens and study designs. PKPD analyses with respect to their impact on development and clinical use of drugs.
Work closely with colleagues in other disciplines to ensure that sufficient preclinical PK-PD knowledge exists to underwrite safe human administration and to establish the structure of a predictive model.
Ensure that there are valid methods for measuring drug concentration (and any biochemical biomarkers) for human studies.
Provide clinical pharmacology support and leadership in various regulatory interactions.

Requirements:

A PhD or MD/PhD in Pharmacology/Pharmacokinetics/Pharmacy/Biological Sciences with hands on quantitative skills and 5-10 years of relevant industry experience.
Demonstrated thorough understanding of the principles of PK, PK/PD and pharmacology relevant to drug candidates.
Knowledge of phase I studies including design and interpretation.
Hands on quantitative modelling and simulation skills and the application of these approaches to drug discovery and development.
Demonstrated ability to write clinical pharmacology results, interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise.
Understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical development plans and studies.
Experience with large molecule products is a plus but not necessary.

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

Contact email address: klausco@verizon.net - 6th May 2010 [1899]

PK SCIENTIST

Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential. To this end, we employ more than 50 percent of our work force in either research and development (R&D) or sales, ensuring our efforts are focused on innovation and our customers. We have the current position open: Pharmacokinetics Scientist:Integrate computer modeling with experimental pharmacokinetic and pharmacodynamic data to optimize development of ocular drug delivery systems. Plan, organize and oversee pharmacokinetic and pharmacodynamic studies to support discovery, pre-development and development. Design, initiate, and develop research projects and project plans to support regulatory submissions, new product design and marketing. Develop research approaches and methods to support R&D. Design and conduct pharmacokinetic and pharmacodynamic studies and overall strategies to support drug discovery, development and product registration. Analyze and interpret pharmacokinetic and pharmacodynamic data to guide interdepartmental drug discovery and development team strategy.Participate as team member on interdepartmental program and project teams.Maintain awareness of current technologies in computer modeling applied to the field of pharmacokinetics and pharmacodynamics.

Education and Experience

Ph.D. in biomedical engineering or pharmacokinetics with minimum of 0-2 years of applicable experience or M.S. in a related field and 4+ years of applicable experience. Essential Skills and Abilities
Skilled use of mechanical modeling software packages, such as Matlab and Abaqus FEA
Familiarity with PK software packages, such as WinNonLin

If you are interested, please apply online at www.allergan.com or email me directly: Jennifer Fisher, staffing consultant, Allergan Inc. klausco@verizon.net

External website http://www.allergan.com

Contact email address: klausco@verizon.net - 6th May 2010 [1898]

Education and Experience

Ph.D. in biomedical engineering or pharmacokinetics with minimum of 0-2 years of applicable experience or M.S. in a related field and 4+ years of applicable experience. Essential Skills and Abilities
Skilled use of mechanical modeling software packages, such as Matlab and Abaqus FEA
Familiarity with PK software packages, such as WinNonLin

If you are interested, please apply online at www.allergan.com or email me directly: Jennifer Fisher, staffing consultant, Allergan Inc. klausco@verizon.net

External website http://www.allergan.com

Contact email address: hprice@clinforce.com - 5th May 2010 [1897]

Associate Director of Pharmacometrics-Located in NJ

PhD, MD or PharmD in PK, Engineering, Mathematics, Statistics, Medicine, Physiology, or related field. 8-10 years of pharmaceutical experience required in mathematical modeling, simulation with NONMEM, S-ADAPT, S-PLUS, MATHCAD, GastroPlus, and SAAM II.

Responsibilities include:

Implementing advanced modeling and simulation techniques in support of drug development
Developing the biologic basis of model of diseases and compound-drug effects on the target as well as pathophysiology of the disease
Aiding in the developing of PK/PD and translational medicine biomarker outcomes for protocol development and trial simulation in collaboration with teams
Aiding in the identification of biomarkers that may be applicable to selection of patient population
Presenting and interacting with health authorities and academic centers
Participating on cross-functional teams
Integration of PK/PD biomarkers and samplings
Managing CRO analyses and reporting of studies

All interested parties must contact: Holly Price Senior Recruiter ClinForce, LLC 919-433-3826 hprice@clinforce.com

Contact email address: reggie.arjungi@regeneron.com - 5th May 2010 [1896]

Regeneron Pharmaceuticals - Tarrytown New York

Experienced preclinical drug development scientist with strong and documented written and verbal communication skills needed for full-time position in the Preclinical Development and Protein Science group. The incumbent will independently author Pharmacokinetic Written Summaries and Nonclinical Overviews in support of IND and BLA submissions for biotechnology-derived drugs. Responsibilities will also include contributing nonclinical PK and TK sections for IBs and FDA Briefing Packages as well as independently interpreting data from nonclinical PK and TK studies and authoring the associated, IND or BLA-supporting reports.

The ideal candidate will hold a PhD degree in pharmacokinetics, pharmaceutics, pharmacology, or toxicology and will have at least 3 years of experience providing nonclinical PK and TK support on cross-functional drug development teams within a pharmaceutical company. Ability to independently author the associated sections of regulatory submissions and supporting study reports is a must. Candidates with an MS degree and demonstrated, strong written and verbal communication skills with at least 8 years of relevant experience providing nonclinical PK or TK support on drug development teams will also be considered. Computer proficiency (Word, Excel, Adobe and related software) and fluency in the English language is required and WinNonLin experience is highly desirable. The hiring level is commensurate with experience.

External website https://sh.webhire.com/servlet/av/jd?ai=874&ji=2384868&sn=I

Contact email address: shanta.lama@vedicsoft.com - 5th May 2010 [1895]

Position Title: Statistician Location:PA Job Type: FullTime

Requirements: Serve as the project statistician to coordinate all statistical project activities Prepare statistical analysis plans, with supervisory input Review computer-generated tables to verify accuracy Prepare key portions of the integrated clinical/statistical report, ISS and ISE, including sections related to data handling and statistical methodology, patient accountability, baseline comparability, and efficacy results Master’s Degree in Statistics (or related discipline); Ph.D. preferred Two years relevant experience with drug development statistical analysis (Phase I and PK/PD experience preferred) Proficiency in SAS programming Excellent communication skills

If you are interested or know someone who is looking for projects, please apply by emailing the resume ASAP to shanta.lama@vedicsoft.com Along with below details. You can call me at 732-623-9900 Ext. 2987 to discuss this opportunity or please forward your updated resume.

5th May 2010 [1893]

In this role, the individual will have the responsibility to lead the clinical pharmacology development of TA programs in exploratory and full development. This individual will manage the clinical pharmacology profiling for TA, including drug interaction, age and gender, renal and hepatic impairment, food effect, and absorption distribution metabolic excretion studies in healthy volunteers as well as contribute to the design, planning, execution and interpretation of studies conducted in early clinical development. The candidate will be responsible for the creation and design of the clinical pharmacology plan in full development and contribute to the clinical pharmacology aspects of the clinical plan in early clinical development. The individual will oversee and manage the clinical study process from protocol development to final study report through regulatory dossier production, preparation of protocols and conduct of clinical studies for products that have been determined to satisfy a medical need and offer a commercial potential. The candidate will also serve as a clinical pharmacology expert to peers and direct reports, across the organization and to government regulatory agencies. The candidate will be responsible for and oversee the preparation of the clinical pharmacology components of regulatory submissions and responses to regulatory authority questions. The individual will represent the department at the development matrix team level to ensure integration of the clinical pharmacology plan with the global development plan.

Requirements for the position include a Ph.D. in pharmacology or pharmacokinetics or a PharmD with a clinical pharmacology research fellowship. A minimum of 5 years of direct pharmaceutical industry experience is required. Experience as a study director contributing to the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation, review and reporting of results for multiple projects as well as experience developing clinical pharmacology plans is needed. The candidate must have previous experience in preparing regulatory submissions, including NDAs and INDs and responding to regulatory questions related to pharmacokinetics and pharmacodynamics. Knowledge of modeling and simulation techniquesand related data interpretation is highly desirable. The candidate will requirestrong communication and leadership skills working in a highly matrixed organization, with a successful track record, mentor and developer of people is a plus.

All interested please reply with CV to jchapman@haallc.com for further discussions.

Contact email address: jchapman@haallc.com - 5th May 2010 [1892]

Position Summary:

Provide quantitative pharmacokinetic and pharmacodynamic modeling and simulation expertise to pre-clinical and clinical project teams. Apply quantitative PK /PD modeling and simulation to inform dose selection and dosing schedule for pre-clinical and clinical studies and provide design goals for drug candidates. Collaborate, mentor and guide other PK-PD team members with pharmacometric support on their projects. Be a champion and advocate for pharmacometrics within the company.

Major Duties and Responsibilities (including supervising others):

Actively advocate and champion pharmacometrics across the company
Able to build, lead and establish a core modeling group with pharmacometrics expertise supporting projects
Plan, design, analyze, interpret and report pharmacokinetic and pharmacodynamic data from pre -clinical and clinical studies
Perform population PK, PK/PD modeling, analysis and interpretation of pre-clinical and clinical data
Perform population PK, PD and PK/PD simulations for pre-clinical and clinical studies
Prepare PK, PK/PD and population PK components of investigators brochure, study protocols, study reports, project summaries and development plans
Perform PK/PD simulations and predict pre -clinical and clinical PK as appropriate
Perform PK-clinical endpoint/outcomes modeling and simulation to support dose selection and overall clinical study design
Investigate relationship between PK and clinical effects, biomarkers and side -effects
Provide expert advice on issues relating to PK, PD, patient population, and dose/regimen selection to project teams
Interpret and present project related study results and recommendations to management and relevant project and therapy teams
Collaborate, mentor and guide other PK-PD team members with pharmacometric support on their projects.
Interact cross-functionally with other departments including Medical Organization, Research, Translational Science, Clinical Testing Laboratory, Drug Safety, Biostatistics, Clinical Development and Regulatory Affairs groups.
Provide PK support for formulation development
Prepare and/or review PK, PK/PD components of internal documents, briefing books and regulatory submission documents (e.g. IND, NDA, IB and other regulatory documents)
Prepare appropriate responses to regulatory health authority inquiries on PK and PK/PD related issues
Provide PK, PK/PD and pharmacometrics expertise in regulatory and other advisory meetings
Actively prepare, review and publish scientific publications and abstracts
Pharmacokinetic & Pharmacodynamic department representative on project teams

All interested please submit your CV to jchapman@haallc.com for further discussions.

Contact email address: broseberry@cartermackay.com - 3rd May 2010 [1891]

Northeast US client is looking for a PhD with 10+ years experience in in vivo toxicology and preclinical efficacy models with large molecule (protein/peptide) therapeutics. Must have animal model experience for efficacy indications, and prior experience in finding new areas of efficacy for existing products would be a plus. Must be a creative thinker and have an overall good understanding of the drug development process, from preclinical through clinical trials. Knowledge in immunology, PK, cell biology, and toxicology is essential. Must have strong leadership skills and be able to work in a multidisciplinary environment. If interested or for a more detailed description, send resume to broseberry@cartermackay.com

Contact email address: job@aktivia.se - 29th Apr 2010 [1890]

Director DMPK and Bioanalysis to Medivir AB, Stockholm

Medivir is an innovative pharmaceutical company with a focus on infectious diseases dedicated to provide patients with new and innovative products, to prevent and cure diseases and to enhance their quality of life. Medivir invent, develop and intends to successfully market pharmaceuticals that effectively and selectively inhibit protease and polymerase enzymes as drug targets. Medivir’s business focus is to be a profitable, medium-sized high-growth pharmaceutical company with its prime strength in infectious diseases within a five-year period. The portfolio consists of ten projects, of which Xerclear™ is in the market launch phase, six projects are in clinical or preclinical development stage and the remaining three are in earlier phases. The company has been quoted on NASDAQ OMX Stockholm since 1996.

The successful candidate will take on the position as Director of DMPK and Bioanalysis. The department consist of eight employees working in DMPK, in vivo and in vitro, and in Bioanalysis. The work, which is conducted in modern facilities with advanced analytical instrumentation, is research intensive with a working climate characterised by innovation, creativity and delivery.

The candidate will have a Ph.D. in a relevant discipline and with good theoretical and practical knowledge and understanding in all major areas of DMPK, e.g. in vitro and in vivo assays for metabolism and permeability, bioanalysis, scaling to man and PK and PK/PD calculations. The candidate will have a track record as specialist within one of the above areas and will have a minimum of 5 years of experience from the pharmaceutical industry with a very good understanding of the R&D processes. The candidate must also have strong ability to document work in written reports and to present orally for both internal and external audiences. Strong leadership abilities and demonstrated experience of teamwork is a key required for this position. The position reports to the CSO.

Medivir is cooperating with the recruitment agency Aktivia Personalkonsult AB in this recruitment project so questions related to this position should be made to Mr. Knut Natt och Dag at +46 709 56 40 46 or Mr. Rolf Mayer at +46 708 87 60 05. Applications containing a CV and a short personal letter should be sent to job@aktivia.se. We are working rapidly with this recruitment project and would like to receive your application as soon as possible.

External website http://www.aktivia.se

Contact email address: rlp@judge.com - 26th Apr 2010 [1887]

PROTEIN BIOANALYTICS LAB HEAD

Technical leader with a Ph.D. in immunology, biochemistry or a related field and at least 5-10 years of experience in protein bioanalytical techniques with both managerial and recent hands on experience in quantitative protein ligand binding assays. Will design and conduct immunogenicity studies, ADA Assays, Neutralizing Antibody Assays, etc. Major Pharma firm in the greater NY area.

Contact: Bob Poz rlp@judge.com

External website http://www.judge.com/jobseekers_industry_scientific_clinical.aspx?openind=yes

Contact email address: ramesh.akkarapak@makroscientific.com - 26th Apr 2010 [1886]

Job Details: Job Title: Clinical Pharmacologist Location: New York City, NY

Primary Duties:

Responsible for providing the clinical pharmacology components of Clinical Plans and provides clinical pharmacology expertise to the project team.
Plans, designs and oversees clinical pharmacology studies as required throughout all stages of drug development with operational assistance from Clinical Research Operations.
Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the CP study.
Accountable and responsible for non-compartmental analysis of PK data and accountable for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, meta-analysis etc.
Directs the planning of all relevant PK-PD analyses. Responsible for use of innovative analytical methods to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states to optimize doses, dosage regimens and study designs throughout clinical drug development in collaboration with pharmacometrics and statistics.
Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc) to the clinical and Development teams and in regulatory documentation such as labeling.
Leads clinical pharmacology contributions to all regulatory documents including Investigator Brochures, EOP2 meetings, NDA/MAA, and post-approval filings. Leads the resolution of clinical pharmacology queries from drug regulatory agencies, takes a lead role in writing and reviewing responses to regulatory queries
Provides Clinical Pharmacology expertise to Discovery as appropriate. During the pre-clinical stages of drug development works with Research to ensure that sufficient preclinical PK-PD knowledge exist to underwrite safe human administration.
Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations.

Qualifications

Ph. D. or equivalent in Pharmacokinetics, Pharmaceutics, Pharmaceutical Chemistry, Pharmaceutical Sciences, Pharmacy (with thesis specialization in Pharmacokinetics) or Pharmacology or M.D. with specialization in Clinical Pharmacology and Pharmacokinetics with 5+ years of experience in the job or related field.
The Ph.D. and/or post-doctoral curriculum must include training in the theoretical aspects of PK, both noncompartmental and modeling techniques.
Must have training or hands-on experience with at least one PK related software application.

For further details, Please contact me at Ramesh Akkarapaka Talent Acquisition Team - Clinical Operations Tel: 973 481 0100 Ext: 3059 Fax: 973 481 1020 ramesh.akkarapak@makroscientific.com

Contact email address: broseberry@cartermackay.com - 26th Apr 2010 [1885]

Looking for a PhD, DABT preferred, to execute in vivo toxicology and safety pharmacology studies in rodents. Will work with preclinical staff to plan/conduct studies in accordance with safety assesment. Should have good knowledge in ADME and also be proficient in cGLP practices. Knowledge of WinNonLin for PK analysis would be a plus. Requires PhD and 2+ years industry experience within in vivo toxicology. Contact broseberry@cartermackay.com

Contact email address: broseberry@cartermackay.com - 26th Apr 2010 [1884]

Director, Bioanalysis Responsible PhD needed to manage bioanalytical dept. responsible for analyzing small and large molecule (peptide) therapeutics. Must have knowledge of GLP compliance as well as routine LC/MS/MS, cell based, and immunoassay techniques. Must have good understanding of ELISA and other techniques. Will work in a matrix team environment and serve as the technical expert in the department. Will also manage CRO's, staff of scientists, and provide advice in compound development and issues relating to antigenicity. Must have experience in preparing regulatory documents and be able to manage a budget. For more information, send CV to broseberry@cartermackay.com must be eligible to work in the US

Contact email address: recruitment@simcyp.com - 16th Apr 2010 [1882]

Pharmacologist/PKPD Research Scientist

Closing Date for Applications:27th May 2010 Line of Management: Reports to Principal Scientist Hours of Work: Mon – Fri 9.00am – 5.00pm (1hr lunch time) Holiday Entitlement: 25 days, plus statutory bank holidays Salary: Commensurate with experience, plus pension contribution, health scheme etc. Location: Sheffield (UK)

Job Overview: We have immediate openings for two Pharmacologists/PKPD Research Scientists who are keen to apply their skills to support the development of models of disease and pharmacodynamic (PD) response, bridging mechanistic and semi-empirical approaches to the simulation of drug action in different populations. The roles involve both the development and the application of models, building on the pharmacokinetic (PK) simulation and parameter optimization capabilities of the Simcyp Population-based ADME Simulator. Candidates should have experience in some of the following areas: receptor pharmacology experiments/theory, clinical pharmacology, systems biology, genetic and other physiological regulatory mechanisms, data analysis or modelling in pharmacokinetics/pharmacodynamics (PKPD).

The successful applicants will join an internationally recognised, multidisciplinary team in which they will be expected to take part in developing models and algorithms within the current framework of modelling and simulation guided by the Simcyp Consortium of clients.

Requirements:

Preferably a higher degree (or equivalent experience) in a relevant field: Pharmacology; PKPD; Toxicology; Physiology; Medicine; Biomedical Sciences.
Demonstrable communication skills, as evident by history of presenting at scientific meetings and/or publication in peer-reviewed journals, with good interpersonal and organizational skills.
Work experience and knowledge of pharmacology including receptor mechanisms, in vitro experiments, regulatory physiology, disease models, biomarkers, PKPD.
Industrial experience/previous working knowledge of commonly used PKPD or computational biology tools would be advantageous.
Some understanding of a programming language such as Fortran/C/C++/C# is preferable but not essential.

Please visit www.simcyp.com for further details Applications: Please send your CV, covering letter (quoting ref: Sim/Res/May10) and names of two references to recruitment@simcyp.com, or post to: Recruitment Simcyp Limited The Blades Enterprise Centre John Street Sheffield, S2 4SU United Kingdom

External website http://www.simcyp.com

Contact email address: broseberry@cartermackay.com - 12th Apr 2010 [1880]

Associate Director, Pharmacovigilance

West Coast client is seeking a qualified candidate to act as the Associate Director, Pharmacovigilance Operations. Will be responsible for providing global safety surveillance for both investigational and marketed products. Must ensure that pharmacovigilance and data archive systems are compliant with 21 CFR part 11.

Will contribute to relevant sections of regulatory submissions (IND, CTX, NDA, etc)and also review relevant safety information. Will participate in safety discussions, represent pharmacovigilance on project teams, and liase with regulatory affairs. Will also manage dictionaries used for coding medical terms and drug names in clinical trials and postmarketing databases. Requirements: PhD or equivalent with atleast 5 years of experience including clinical IND drug safety/and or postmarketing. Must have working knowledge of pharmacovigilance, ICH guidelines, and FDA requirements in clinical document preparation.

Contact email address: enelson@humanstrategy.com - 8th Apr 2010 [1878]

I am actively sourcing candidates for a long term post as a liaison & subject matter expert between BARDA (Government) and companies and independent researchers developing countermeasures. This is an excellent opportunity to work for a premier consulting group on diverse cutting edge projects for the government.

In this role you will serve as a scientific and technical SME reviewing ongoing programs and proposals with regard to programs/products concerning the development of medical countermeasures to treat the deleterious effects of chemical/radiological/nuclear injuries (chemical/rad/nuc injuries to the body). Having tox/PK/Testing experience in these areas is pref. You will work as part of a team and perform reviews of proposals and participate in technical evaluation panels. You will conduct site visits/audits with contractor facilities that are working to develop new countermeasures.

This position requires that you have earned a Ph.D. or M.D that is complimented by 10+ years research and project/management experience. You will have relevant basic and translation research and specific experience with radiobiology/dosimetry. You will ideally have experience in focused product development for medical countermeasures and knowledge of infrastructure and process for research development. The ideal candidate for this position will have extensive exposure to the tests/tools used to test as many different kinds of insults the body could be exposed to (including radiological and chemical injury) because the broader the exposure to how the body is affected by these injuries and having a broad testing background, the better knowledge base the candidate will have to advise both the government agency and product development efforts of companies and researchers developing products and countermeasures.

DC based position. Base up to $170K. Long term (3-4 yr) 1099 contract. Could consider MA with right experience.

Please let me know if you would like to learn more about this post. If not, please consider passing my information through to your network. I appreciate any response as well as the opportunity to share my work with you.

Best, Emily Nelson enelson@humanstrategy.com 208.232.2070

External website http://www.humanstrategy.com

Contact email address: Kelleo@clinforce.com - 7th Apr 2010 [1877]

Candidate will be responsible for the following.

1. Provide broad knowledge of advanced field or extensive knowledge of theories/practices within pharmacokinetics/drug metabolism and bioanalytical fields or related disciplines. 2. Understand and integrate information from more than one discipline and apply to complex problems requiring innovative techniques. Recognized throughout the division or as an expert troubleshooter of difficult technical problems as evidenced by repeated requests for assistance. 3. Consistently develop and execute novel methods, leading-edge techniques and approaches as well as innovative theories and technologies. Initiate, develop and lead technical feasibility analysis where new and unproven methods and technologies are required. 4. Incorporate knowledge of customer requirements and research analysis to make recommendations to meet business unit plans. Conceive design concepts and research methodologies that result in both breakthrough technologies and have a significant impact to the health care industry. 5. Recognized throughout for broad technical expertise as evidenced by solicitation of input on a variety of issues from across the field. 6. In addition to having an in-depth knowledge and understanding of GLP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations. 7. Participates in global task forces and committees. Routinely initiates exchanges of technical information with other research and support groups throughout the Corporation to meet business objectives. Interacts regularly with senior scientific staff.

1. Has record of additional training and accumulation of expertise post Ph.D. 2. Has numerous scientific publications, invention filings, patent applications, and/or technical achievements. 3. Frequently makes presentations inside and outside of. Invited to participate in scientific meetings, conclaves, etc. 4. MS with min. 20, or PhD with min. 12 years relevant work experience or equivalent. 5. Experience must be sufficient enough for incumbent to have achieved internal and external recognition in broad area of expertise. 6. Research lab experience includes research in GMP/GLP product development, cross-functional teamwork, and independent experimentation in method development and validation.

Contact email address: broseberry@cartermackay.com - 6th Apr 2010 [1876]

Client looking for an accomplished pharmacometrician to be the Director of Pharmacometrics. Must have strong publication record and experience in PK/PD. Must have experience in the planning, design, and interpretation of clinical trial results. Will be expected to perform various compartmental, noncompartmental, bayesian and categorical modeling, as well as data mining. THe candidate must be able to solve complex problems and work effectively with interdisciplinary teams. This is a high profile role within a large organization. Software proficiencies include WinNonlin, NONMEM, SAS, S+, R, Trial Simulator, WinBugs, etc. Qualified candidates please send resume to broseberry@cartermackay.com

Contact email address: broseberry@cartermackay.com - 6th Apr 2010 [1875]

Director, Clinical Pharmacokinetics

Large pharma client on East Coast seeks PhD or PharmD with a minimum of 8 years experience in PK/PD. Will be responsible for clinical trial design for phase I-IV studies, and data analysis/summary study reports. Will manage outsourcing, budgets, and regulatory document submission. The successful candidate will also provide input on project teams, coordinate with bioanalytical on methods used to support clinical studies, provide responses to regulatory agencies and advisory boards. Will prepare PK/PD development plans for drug development. Need to have solid experience with graphing software such as WinNonLin as well as superb communication skills. Please send resume to broseberry@cartermackay.com for consideration and further information.

Contact email address: vicky.depaepe@ablynx.com - 6th Apr 2010 [1874]

Senior) Scientist Pharmacokinetics

Ablynx is seeking an individual with a strong expertise in pharmacokinetic analysis, modeling and simulations to strengthen the pharmacology department. Experience in the field of protein drugs will be an asset. The main focus of the group is the nonclinical pharmacology of novel Nanobodies® in indications such as thrombotic and inflammatory diseases, allergy and cancer. The group supports discovery projects as well as projects in clinical development. The pharmacology team is expected to grow to ~ 50 colleagues by the end of 2010 and is organized in 3 teams: Bio-analysis, in vitro pharmacology and PK-Tox. We look for an individual who has relevant industry experience and who has a solid understanding of the PK/PD behavior of drugs with an emphasis on biologics. The candidate ideally should have experience in working in large inter- disciplinary teams. Good understanding of regulatory requirements for preclinical development as outlined by international guidelines is a plus. Compensation will depend on level of experience.

Responsibilities: Main responsibilities include: Represent the department in project teams. Support and guide project team decisions with scientific advice; Analyze PK/PD behavior of drugs in nonclinical and clinical studies; Predict and simulate nonclinical and clinical PK/PD behavior to guide and justify dosing and sampling schemes; Monitor own PK studies and oversee outsourced activities, collaborate with service providers and academic partners; Prepare and review study protocols and reports Help prepare and review documents relevant for filing to authorities;

Profile: Ph.D. in pharmaceutical sciences, MD or a related field 5 + years of relevant experience Proven track record in modeling and simulations Experience in working in interdisciplinary groups is a plus Team player, independent and motivated

External website http://www.ablynx.com

Contact email address: contcsc@optonline.net - 5th Apr 2010 [1873]

Associate Director Pharmacokinetics/Principal Scientist

RESPONSIBILITIES: Perform PK and PK/PD data analysis, modeling, simulation and prediction to provide human dose projection and exposure based on extrapolation from in vivo or in vitro data. Perform and implement both in vitro and in vivo experiments to acquire siRNA and their associated delivery systems PK, PK/PD and ADME properties. Represent DMPK in interdisciplinary project teams and provide guidance to implement strategies to enable programs to select drug candidates for nomination into development. Able to work independently and in a matrix team environment, including partner companies. Report writing for IND and NDA filings including the writing of SOP,s.

REQUIREMENTS: PhD/PharmD degree in Pharmacokinetics with at least 8 years of industrial experience in the evaluation large or small molecule therapeutics. Excellent knowledge in PK and drug metabolism principles is a must with working knowledge of PK/ADME science as related to drug discovery, development, delivery or general disposition. Experience in PK, and PK/PD data analysis including PK & PK/PD modeling, simulation and prediction is a must. Familiarity with various PK software packages, such as WinNonLin, ADAPT, SAAMI and NONMEM. Prior experience with IND,s, BLA,s and/or NDA,s is highly desirable.

Contact email address: bioehire@u.washington.edu - 30th Mar 2010 [1872]

The University of Washington Department of Bioengineering

The Department of Bioengineering and the School of Pharmacy at the University of Washington invite applications for a tenure track position in the area of Pharmacometrics. The primary appointment will reside in the Department of Bioengineering, School of Medicine, with a joint appointment in the Department of Pharmaceutics, School of Pharmacy. Areas of interest include, but are not limited to:

Development and testing of sophisticated pharmacometric models (e.g. PK/PD models and/or population PK/PD models) Development and application of models of disease pathophysiology and pharmacological management Development of novel therapeutic strategies utilizing systems biology and pharmacometric principles Development of mathematical statistical, and systems tools needed to solve these types of pharmacometric modeling problems

Applications are sought at all levels including Assistant, Associate or Full Professor. Ph.D., PharmD or M.D. degrees are required, and prior post-doctoral or higher level experience is valued. The successful candidate will be expected to develop an internationally recognized research program and to participate in the teaching and service missions of the two departments, Bioengineering and Pharmaceutics. Scientists and engineers who apply should show evidence of excellence, originality and productivity in research and potential for excellence in teaching.

Successful candidates will find a thriving world-class research setting for interdisciplinary work at the interface of medicine, pharmacy, and engineering, and across the spectrum of fundamental discovery research to translational and clinical medicine. The UW has been perennially ranked in the top 3 nationally for federal research funding and received over $1 billion in sponsored research in FY2007. The Department of Bioengineering has vibrant centers of excellence in drug delivery, nanotechnology, and biologic drug development. The department led the nation in NIH grant funding for Bioengineering over the past decade and has annual external research funding of ca. 30 million dollars. The School of Pharmacy is ranked #1 nationally for Schools of Pharmacy in research funding per faculty and The Chronicle for Higher Education ranked the Medicinal Chemistry and Pharmaceutical Sciences research programs “best in the nation,” based on faculty scholarly activities. Further outstanding collaborative opportunities exist with the new Institute for Health Metrics and Evaluation, within the Schools of Medicine and Public Health (www.healthmetricsandevaluation.org).

Applications must be submitted electronically at http://www.engr.washington.edu/facsearch/?dept=BioE. Applicant review will begin in March 2010 and continue until the position is filled. All positions are contingent on the availability of funding.

The University of Washington is building a culturally diverse faculty and strongly encourages applications from women, minorities, individuals with disabilities and covered veterans. Faculty engage in teaching, research and service. The University of Washington is the recipient of a 2006 Alfred P. Sloan Award for Faculty Career Flexibility and a 2001 National Science Foundation ADVANCE Institutional Transformational Award to increase the advancement of women faculty in science, engineering and math. The University is an Equal Opportunity, Affirmative Action Employer.

External website http://www.engr.washington.edu/facsearch/?dept=BioE

Contact email address: klausco@verizon.net - 29th Mar 2010 [1871]

Allergan Inc. Located in Irvine, CA is looking for a Director of Clinical Pharmacology.

Director of Clinical Pharmacology: Leads and drives all resource management, operational and administrative aspects in global clinical pharmacology by ensuring the execution of these studiesfor successfully development and registration. Exercises a high degree of quality, productivity and communication to the department and therapeutic areas for the timely completion of all clinical studies. Hires, develops and motivates staff to ensure scientifically valid studies conducted according to Good Clinical Practices. Leads assigned clinical pharmacology teams to rapidly deliver studies, which meet minimum and desired requirements in an efficient manner using high quality scientific rationale. Contributes to Global Clinical Pharmacology strategic and operational development by active participation in the CPQS leadership team. The employee must conduct their work activities in compliance with all Allergan internal requirements and with all applicable regulatory requirements. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

Bachelors degree with experience in a relevant field; BS degree with 15 years experience, MS degree with 12 years experience, Pharm D degree with 8 years experience
Clinical Pharmacology experience strongly preferred
Minimum 8 years experience working in a clinical pharmacology operations organization, preferably within pharma or CRO
Minimum of 8 years experience working in clinical research with a strong understanding of the clinical and drug development process
Minimum 8 years leading and managing highly diverse and educated teams

Please email me: Jennifer Fisher, Staffing Consultant HR, Allergan klausco@verizon.net

External website http://www.allergan.com

Contact email address: laura.stockman@thersagroup.com - 29th Mar 2010 [1869]

Senior Director, Modelling & Simulation

Competitive Package Germany You will join a leading, family-owned German corporation as it embarks on a major and forward-thinking transformation programme. Reporting to the SVP, Global Clinical Development, you will be part of the senior management team tasked with re-shaping, modernising and re-invigorating Global Clinical Development, creating a key business area with the technical skills, leadership skills and processes to become a world leader in the development of novel therapies for the treatment of acute and chronic pain.

In this newly created, Senior Director level position, you will build up a new department and define and lead the modelling & simulation strategy and activities across all project teams. You will build, mentor and direct the performance of a team of specialist scientists, internally championing the use of modelling & simulation tools and building an understanding of the added efficiency and effectiveness a population approach can bring to drug development. Externally, you will liaise with key opinion leaders and regulatory authorities to ensure that internal drug development programmes are kept abreast of the latest research and future directions in the field.

A PhD or MD, you will bring to the role extensive experience in pharmaceutical modelling and simulation. This will have spanned the entire value chain, with a particular emphasis on exposure-response modelling and clinical trial simulation. Prior experience of interacting with global regulatory authorities is essential for success in this high-profile role. A strong and inspirational leader, you will bring a successful track record of leadership achievements, combined with the ability to motivate, coach and build a world-class modelling & simulation department.

To apply, please e-mail your CV to 10221@theRSAgroup.com. Alternatively, call Laura Stockman on +44 (0)1707 259333 for an initial confidential discussion.

Contact email address: kelleo@clinforce.com - 29th Mar 2010 [1868]

Principal Scientist PK Director Level- Chicago

Job Description 1. Provide broad knowledge of advanced field or extensive knowledge of theories/practices within pharmacokinetics/drug metabolism and bioanalytical fields or related disciplines. 2. Understand and integrate information from more than one discipline and apply to complex problems requiring innovative techniques. Recognized throughout the division or as an expert troubleshooter of difficult technical problems as evidenced by repeated requests for assistance. 3. Consistently develop and execute novel methods, leading-edge techniques and approaches as well as innovative theories and technologies. Initiate, develop and lead technical feasibility analysis where new and unproven methods and technologies are required. 4. Incorporate knowledge of customer requirements and research analysis to make recommendations to meet business unit plans. Conceive design concepts and research methodologies that result in both breakthrough technologies and have a significant impact to the health care industry. 5. Recognized throughout the company for broad technical expertise as evidenced by solicitation of input on a variety of issues from across the field. 6. In addition to having an in-depth knowledge and understanding of GLP and related regulations and guidance, is able to provide expert insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations. 7. Participates in global task forces and committees. Routinely initiates exchanges of technical information with other research and support groups throughout the Corporation to meet business objectives. Interacts regularly with senior scientific staff.

Job Requirements 1. Has record of additional training and accumulation of expertise post Ph.D. 2. Has numerous scientific publications, invention filings, patent applications, and/or technical achievements. 3. Frequently makes presentations inside and outside of the company . Invited to participate in scientific meetings, conclaves, etc. 4. MS with min. 20, or PhD with min. 12 years relevant work experience or equivalent. 5. Experience must be sufficient enough for incumbent to have achieved internal and external recognition in broad area of expertise. 6. Research lab experience includes research in GMP/GLP product development, cross-functional teamwork, and independent experimentation in method development and validation.

Contact email address: hr@hessjobs.com - 22nd Mar 2010 [1866]

Title:PK/PD Study Director or Account Manager Location: Eastern Canada Type: Fulltime / non remote/ nonvirtual

Description: Eastern Canadian clinical research company is looking for a senior, experienced, dynamic study director OR account manager with study direction background to do business development and maintain existing customer relationships.

REQUIREMENTS: B.Sc., previous experience working with clients. 4 to 5 years in the CRO industry as study director or account manager or both. Best if preclinical- animal stage - service sales, but not essential. Experience with contracts, sales targets, revenues interesting but main focus on customer interaction. Self-starter, computer literate, with great people skills. Strong communication skills in English as large proportion of clients are American. Any French of interest. Salary commensurate with experience. Able to travel to the US, other parts of Canada, and the AsiaPacific region. Must live locally and work from company office, not from home. Prefer local Eastern Canadian applicants but others considered.

Key words: cro, contract research organization, account, manager, canada, rolodex, network, connections, sales, clinical, preclinical, toxicology, pk, pd

External website http://www.hessjobs.com

17th Mar 2010 [1864]

Senior Ethnopharmacology Scientist

This exciting new role has been created in response to the growing need for assessments of potential ethnic variability in the efficacy and safety of GSK compounds brought about by the increased alignment of development programs in the West and Japan, China and Asia-Pacific.

This permanent, full time position is part of GSK Research and Development and located in Sydney, Australia. In this role you will provide scientific and technical support as a member of a small multinational, matrix team in Clinical Pharmacology Modelling & Simulation. A good understanding of, or the ability to comprehend, the impact of ethnic variability on the drug development and registration process is essential. In addition to a background including pharmacology, experience in pharmacokinetics and pharmacokinetic modelling, pharmacogenetics and/or drug metabolism is required.

This position requires good scientific writing skills and the ability to evaluate scientific literature. To build good working relationships with a broad cross-section of other R&D functions world-wide, a team player is required, who has pride in achievement and demonstrates personal initiative. A life sciences PhD is necessary and research experience in academia or the pharmaceutical industry would be an advantage.

GlaxoSmithKline is one of the world’s leading research-based pharmaceutical and healthcare companies. By placing a high value on strong ethics, people, accountability and innovation, GlaxoSmithKline is an exceptional place to work.

At GlaxoSmithKline we strive to make a difference. For a new challenge and an opportunity for personal and career development please apply online at www.gsk.com.au/careers before COB Friday April 9.

For further information please contact: annette.s.gross@gsk.com.

External website http://www.gsk.com.au/careers

Contact email address: contcsc@optonline.net - 17th Mar 2010 [1863]

Lead the clinical pharmacology development of 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 including drug interaction, age and gender, renal and hepatic impairment, food effect, and ADME studies in healthy volunteers as well as contribute to the design, planning, execution and interpretation of studies conducted in early clinical development.

Responsible for the creation and design of clinical pharmacology plans in full development and contribute to the clinical pharmacology aspects of the clinical plan in early clinical development.

Supervise a staff of 1-2 Scientists

Oversee and manage the clinical study process from protocol development to final study report through regulatory dossier production, preparation of protocols and conduct of clinical studies for products that have been determined to satisfy a medical need and offer a commercial potential.

Serve as a clinical pharmacology expert to peers and direct reports, across the organization and to government regulatory agencies.

Responsible for and oversee the preparation of the clinical pharmacology components of regulatory submissions and responses to regulatory authority questions.

Represent the department to ensure integration of the clinical pharmacology plan with the global development plan.

Qualifications:

Ph.D. in pharmacology or pharmacokinetics or a PharmD with a minimum of 5 years of direct pharmaceutical industry experience in clinical pharmacology is required. Experience doing hands on PK modeling mandatory.

Experience as a study director contributing to the pharmacokinetic and pharmacodynamic aspects of clinical protocol design, writing, data interpretation, reviewing and reporting of results for multiple projects as well as experience developing clinical pharmacology plans is needed.

Must have previous experience in preparing regulatory submissions, including NDAs and INDs and responding to regulatory questions related to pharmacokinetics and pharmacodynamics.

Application and knowledge of current practices and issues in clinical pharmacology as well as in the bioanalytical, biopharmaceutics, regulatory, non clinical metabolism and pharmacokinetics, pharmacology, and toxicology areas is expected.

Require strong communication and leadership skills working in a highly matrix organization, with a successful track record as a direct supervisor, mentor and developer of people.

Contact email address: jennyx@hmplglobal.com - 12th Mar 2010 [1860]

Scientific Director in the Drug Metabolism and Pharmacokinetics (DMPK), Hutchison MediPharma Limited

Hutchison MediPharma Limited (HMPL) is a leading biotechnology company in China. It was founded in Shanghai Zhangjiang High Tech Park in September 2002 with financial support from the Hutchison Whampoa Group. Hutchison MediPharma's R&D activities are focused on two target therapeutic areas: auto-immune/inflammatory disorders and oncology. Currently, Hutchison MediPharma has several promising anti-inflammatory and anti-cancer drug candidates in various stages of clinical trials and a pipeline of early stage discovery projects. The discovery portfolio largely focuses on novel synthetic single chemical entities, supplemented by botanical candidates.

Hutchison MediPharma is seeking an enthusiastic, highly motivated, and team-oriented candidate for the position of Scientific Director in the Drug Metabolism and Pharmacokinetics (DMPK) group. Primary responsibilities of this position include:

1. Design and conduct of pharmacokinetic studies and complex pharmacokinetic and pharmacodynamic (PK/PD) modeling and simulation activities

2. Application of PK/PD principles to aid in the interpretation of in vivo pharmacology data for the selection and advancement of drug discovery candidates, and supporting development projects.

3. The incumbent will represent PKDM on multi-disciplinary project teams and work collaboratively with other PKDM project leaders in support of the site-wide portfolio of large and small molecules.

Preferred Qualifications:

1. PhD in Pharmacokinetics, 5 or more years of experience modeling PK and PD data in team-oriented environment, either industry or academic setting.

2. High level of working knowledge in WinNonlin, NONMEM, and Microsoft Office applications.

3. Expertise in drug development requirements and strategies, as well as global regulatory requirements, for this business segment.

4. Excellent organizational, oral and written communication and interpersonal skills.

5. Working knowledge of bioanalytical methods and instrumentation used to quantify drug in biological matrices a plus.

Website: www.hmplglobal.com Contact: Ms. Jenny Xu jennyx@hmplglobal.com

External website http://www.hmplglobal.com

Contact email address: Jamie@pharmasearchpartners.com - 11th Mar 2010 [1859]

I have two positions open 1. Director Clinical Pharmacology and PK, location Midwest with a Pharmaceutical client. Looking for experience in Oncology and a Doctoral degree 2. Executive Director Clinical Pharmacology requiring a MD degree and experience leading and growing global teams.This is with a fortune 50 pharmaceutical client please email me at jamie@pharmasearchpartners.com

Contact email address: recruitment@simcyp.com - 8th Mar 2010 [1857]

Senior Scientist in Modelling & Senior Scientist in Biostatistics

Simcyp is a fast-growing, research-based company that provides consultancy, knowledge integration tools, modelling solutions and databases relevant to drug development (implemented in its world-renowned Simcyp Population-based ADME Simulator) for its client base of major blue-chip pharmaceutical and biotechnology organisations.

The Sheffield (UK) based company focuses, in particular, on gathering information required for the modelling and simulation (M&S) of the time-course and fate of drugs (ADME) in patients using experimental data derived from in vitro systems. We are on course to become the global industry standard in this area. Consequently, there is a continuous requirement for high quality people to join us, help in our expansion and share in our success. We offer a unique and exciting mix of both an academic and a commercial environment and encourage regular attendance at scientific meetings as part of continuous education programs. The projects are scientifically challenging yet focused on solving practical issues relevant to modern drug development. All scientists are expected to participate in writing scientific reports relevant to their work under the guidance of our world-leading scientists within the group.

Senior Scientist in Modelling & Senior Scientist in Biostatistics closing date Friday 9th April 2010

Ref: boom/Mod/Biostat/mar10 We have two immediate openings for a biostatistician and a modelling expert who are keen to apply their skills to the development of new models (as opposed to routine data analysis) in drug development, mechanistic PKPD, predicting the fate of biologics and systems biology. Candidates should have experience of applied mathematics, biostatistics and data analysis in pharmacokinetics and/or pharmacodynamics related areas. This may include numerical solution of stiff and high-dimensional differential equations, the application of advanced optimisation techniques, optimal study design theory or Bayesian approaches in parameter estimation of large scale non-linear time-varying systems.

The successful applicants will join an internationally-recognised, multidisciplinary team in which s/he will be expected to take part in developing models and algorithms within the current framework of modelling and simulation guided by the Simcyp Consortium.

If you are interested in joining our team please visit www.simcyp.com to view the full job details or send your CV, covering letter and names of two references to recruitment@simcyp.com, quoting job ref: boom/Mod/Biostat/mar10 and where you saw the advert.

External website http://www.simcyp.com

Contact email address: broseberry@cartermackay.com - 4th Mar 2010 [1856]

PK/PD and drug metabolism Investigator Our client is looking for an individual with experience in both in vivo and in vitro DMPK experiments as well as knowledge in kinetics. Must have good understanding of metabolic pathways and related enzymes. Also required is the operation of LC/MS and sample extraction and preparation. Will be required to interpret nonclinical and preclinical data as well as design in vivo PK/PD studies. Those with demonstrated innovative research in these areas will have an advantage. Prior experience in regulatory writing is also an advantage. Must have a PhD and a minimum of 4 years post-doctoral experience in the pharmaceutical or biotech industry. Also required are strong written and verbal communication skills and the ability to supervise and mentor junior staff. Must have experience working in project teams and contribute to compound selection. US residents only. Please send resume to broseberry@cartermackay.com