PK/PD and Other Jobs

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Contact email address: kevin-rinaldi@ouhsc.edu - 22nd Dec 2009 [1741]

Faculty Position in Pharmaceutical Sciences

The University of Oklahoma College of Pharmacy invites applications for an assistant or associate professor of pharmaceutics in the Department of Pharmaceutical Sciences.

The College of Pharmacy is located within the University of Oklahoma Health Sciences Center (OUHSC), a 325-acre comprehensive academic health center, recently noted for having one of the best academic institution work environments in the country by The Scientist (Nov. 2007). The OU Health Sciences Center has targeted growth in four broad areas: cancer, diabetes, neuroscience/vision and immunology/infectious disease.

The successful candidate will be expected to contribute at least 50% effort to teaching responsibilities of the department in pharmaceutics, coordinate the pharmaceutics laboratory on the OKC campus, and assist in teaching in other courses as necessary. Further information on the College of Pharmacy is available at: http://pharmacy.ouhsc.edu/.

Current research interests within the Department of Pharmaceutical Sciences include pharmacology/toxicology, pharmaceutics, pharmacokinetics, pharmaceutical chemistry, immunology/infectious diseases and nuclear pharmacy. Departmental faculty members may contribute to the Pharm.D., Ph.D. and Pharm.D./M.S. degree programs. Applicants must have a Ph.D. or equivalent degree in a pharmaceutical sciences discipline or closely related field, have experience teaching pharmaceutics and related disciplines in a professional pharmacy curriculum and meet the requirements to work in the United States. Highly qualified candidates will have a significant history of teaching in a professional pharmacy curriculum, a record of meaningful involvement in the education of graduate students and a history of peer-reviewed scholarship.

OUHSC is situated in the capital city of Oklahoma City; an area undergoing extensive revitalization and recently named the most recession-proof city in the United States by Forbes.com (April 2008). Oklahoma City is one of the most economically and geographically attractive major metropolitan areas in which to live.

Review of applications will begin immediately and continue until the positions are filled. Applicants should submit a letter of interest, complete curriculum vitae, description of teaching philosophy and scholarly interest(s), and the names, addresses (postal and email) and phone numbers of at least three professional references to:

Kevin Rinaldi, MBA Attn: Pharmaceutics Faculty Search Committee College of Pharmacy, University of Oklahoma Health Sciences Center PO Box 26901, Oklahoma City, OK 73126-0901 Phone: 405-271-6484, ext. 47291; E-mail: kevin-rinaldi@ouhsc.edu

The University of Oklahoma Health Sciences Center is an Equal Opportunity/Affirmative Action Employer

External website http://pharmacy.ouhsc.edu/employment/index.asp?ID=35

Contact email address: kevin-rinaldi@ouhsc.edu - 22nd Dec 2009 [1738]

Faculty Positions in Pharmaceutical Sciences

The University of Oklahoma College of Pharmacy invites applications for multiple faculty positions in the Department of Pharmaceutical Sciences. Tenure track positions are currently available for Assistant/Associate/Full Professors within the department.

The College of Pharmacy is located within the University of Oklahoma Health Sciences Center (OUHSC), a 325-acre comprehensive academic health center, recently noted for having one of the best academic institution work environments in the country by The Scientist (Nov. 2007). The OU Health Sciences Center has targeted growth in four broad areas: cancer, diabetes, neuroscience/vision and immunology/infectious disease.

Current research interests within the Department of Pharmaceutical Sciences include pharmacology/toxicology, pharmaceutics, pharmacokinetics, pharmaceutical chemistry, immunology/infectious diseases and nuclear pharmacy. Successful candidates will be expected to contribute to teaching responsibilities of the department in these areas. At this time the department is undergoing a major expansion. Further information on the College of Pharmacy is available at: http://pharmacy.ouhsc.edu/.

Departmental faculty members may contribute to the Pharm.D., Ph.D. and Pharm.D./M.S. degree programs. Applicants must have a Ph.D. or equivalent degree in a pharmaceutical sciences discipline or closely related field and meet the requirements to work in the United States. Highly qualified candidates will have significant post doctoral experience, a record of meaningful involvement in the education of professional and graduate students, and a strong track record of extramural research funding or industrial productivity. The successful applicant may also be eligible to receive an Endowed Professorship.

OUHSC is situated in the capital city of Oklahoma City; an area undergoing extensive revitalization and recently named the most recession-proof city in the United States by Forbes.com (April 2008). Oklahoma City is one of the most economically and geographically attractive major metropolitan areas in which to live.

Review of applications will begin immediately and continue until the positions are filled. Applicants should submit a letter of interest, complete curriculum vitae, description of research interest(s), and the names, addresses (postal and email), and phone numbers of at least three professional references to:

Kevin Rinaldi, MBA Attn: Pharmaceutical Sciences Faculty Search Committee College of Pharmacy, University of Oklahoma Health Sciences Center PO Box 26901, Oklahoma City, OK 73126-0901 Phone: 405-271-6484, ext. 47291; E-mail: kevin-rinaldi@ouhsc.edu

The University of Oklahoma Health Sciences Center is an Equal Opportunity/Affirmative Action Employer.

External website http://pharmacy.ouhsc.edu/employment

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

Contact email address: broseberry@cartermackay.com - 2nd Mar 2010 [1855]

Clinical Pharmacology Position--Title depending on experience--US

My client is in the Northeast US and is looking for a PhD with several years experience in PK/PD data analysis, clinical pharmacology, and working knowledge of WinNonLin and NONMEM. Experience working with large and small compounds is a plus, as is good knowledge in immunology as far as understanding antibodies and fusion proteins. Must have experience in analyzing physiologically based PK/PD data. Title dependent on experience. Contact broseberry@cartermackay for more information

Contact email address: rlp@judge.com - 26th Feb 2010 [1854]

Our client is a Major Pharmaceutical firm in NJ SENIOR RESEARCH INVESTIGATOR - MODELING & SIMULATION Position Description and Responsibilities: Will develop models of drug exposure, exposure-biomarker response, and disease progression (in particular for HCV, T2DM, and/or Alzheimer's disease) to facilitate drug development decisions, and will be responsible for: (1) collaborating with cross-functional team members to address key program and portfolio level questions by disease progression models; (2) resourcing and execution of the M&S plans; (3) reporting and interpretation of M&S results to inform decisions at clinical development milestones, and (4) contributing to regulatory submissions (pre- and post-approval). The individual will also be expected to develop M&S plans to bridge available data from compounds within and across development programs to inform portfolio level decisions. This individual will represent the M&S function in cross-functional matrix/project teams, and identify and respond to opportunities for M&S input over the course of drug development.

Position Requirements: Ph.D. and/or M.D. in medical/pharmaceutical sciences or engineering or a related field, with 1-3 years of post-doctoral (in industry or academia) experience in M&S (population pharmacokinetic, exposure-response and disease progression) analyses using S-PLUS/R and NONMEM. Strong oral and written communication skills necessary to formally present and report information internally and externally is required. The ability to work in a dynamic team oriented environment is essential.

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

Contact email address: broseberry@cartermackay.com - 25th Feb 2010 [1853]

Principal Scientist, Team Lead

The successful candidate will be responsible for conducting and reporting plant and animal bioconcentration and metabolism studies for product registration following regulatory testing/current GLPs, including the use of the Microsoft platform. Also responsible for monitoring regulatory and technical changes, along with their incorporation and providing significant input to the marketing of these services. Will lead a team of lab personnel as well as be in charge of performace reviews, time off, etc.

Requirements: BS degree and 15 years comparable laboratory experience. MS degree and 8 years of comparable laboratory experience. Ph.D and 5 years of comparable laboratory experience.

Knowledge/experience desired: Preferably prior experience in a CRO environment as well as working with C14 material. Product chemistry testing experience/E-fate also helpful. US residents only. If interested, send CV to broseberry@cartermackay.com

Contact email address: giorgia.signoretto@thersagroup.com - 25th Feb 2010 [1852]

Senior Scientist / Project Representative, in vivo Pharmacokinetics - Research DMPK

Excellent Opportunity; Location: Belgium.

You will join an established biopharmaceutical company, dedicated to the discovery, development and commercialisation of innovative pharmaceutical and biopharmaceutical products in the fields of CNS and immunology.

Based within the CNS Research Hub and reporting to the Senior Director of Research DMPK, you will be responsible for the provision of practical and strategic PK support to all CNS drug discovery projects. You will be the primary point of contact on all issues relating to PK, PK/PD and PB/PK and will work closely with CNS Pharmacology and Experimental Medicine on the design and optimisation of in vivo pharmacological and early clinical models. As a senior member of the Research DMPK department, you will also take a leading role in the DMPK support to drug discovery project teams, defining the DMPK strategy, providing data interpretation and risk assessment and influencing project strategy.

Educated to MSc or PhD level, you will bring to the role several years pharmaceutical or biotechnology industry experience, gained within a Discovery DMPK environment. You will demonstrate a strong technical background in a range of in vivo and in-vitro DMPK methodologies including bioanalysis, and a successful track record of representing your department on project teams. A good knowledge of the application of PK, PK/PD and PB/PK tools in drug discovery is essential in this high profile role. As a proactive and flexible networker with strong project management and influencing skills, you will have the knowledge and personal presence to be recognised as an internal expert in PK and PK/PD.

To apply, please contact Giorgia Signoretto on +44 1707 228612 or giorgia.signoretto@thersagroup.com

Contact email address: contcsc@optonline.net - 24th Feb 2010 [1850]

In this role, you will lead the design, analysis, interpretation and reporting of pharmacokinetic/pharmacodynamic, drug disposition, and drug metabolism data from clinical studies utilizing state of the art technology in support of clinical development plans.

Perform pharmacokinetic and pharmacodynamic modeling, contribute to PK/PD related regulatory documents and draft PK/PD sections in support of clinical development plans, and provide PK/PD perspective on cross functional teams.

Participate in regulatory interactions as needed as well as evaluate feasibility of clinical studies and provide input to the design and review of clinical protocols.

Qualifications

Requirements for this position include a Ph.D. or a PharmD with at least 1 year of industry experience in pharmacokinetic, pharmacodynamic and drug metabolism techniques.

Experience designing, conducting and interpreting studies in population PK, PK/PD correlations. Light modeling and simulations experience required.

Display strong written and oral communication skills necessary to deliver scientific presentations.

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: contcsc@optonline.net - 24th Feb 2010 [1849]

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.

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: vijayr@mail.nih.gov - 20th Feb 2010 [1848]

Post-doctoral Fellowship in Alcohol Clinical Pharmacology – NIAAA Laboratory of Clinical and Translational Studies

We are recruiting a postdoctoral fellow to conduct research in the Section on Human Psychopharmacology of the Laboratory of Clinical and Translational Studies (LCTS) at the National Institute of Alcohol Abuse and Alcoholism (NIAAA), a part of the National Institutes of Health (NIH), Department of Health and Human Services (DHHS). The laboratory is located within the Mark O. Hatfield Clinical Research Center on the main NIH intramural campus in Bethesda, MD, an outstanding research environment.

The research conducted by the Section is focused on evaluating genetic and environmental factors influencing the pharmacokinetics and pharmacodynamics of alcohol in humans, as well as the development of human laboratory paradigms, utilizing intravenous alcohol challenges and self-administration methods, to screen novel potential medications for the treatment of alcoholism.

Candidates with a Ph.D., Pharm.D./Ph.D., or M.D./Ph.D. in clinical pharmacology, psychology, neuroscience, or related field, are encouraged to apply. Strong verbal and written communication skills are essential. Salary will be set commensurate with experience and accomplishments. To apply, candidates must click on the button below, or submit a letter of application, along with CV including list of publications, and three letters of recommendation, to Dr. Vijay Ramchandani by e-mail to vijayr@mail.nih.gov or by mail to:

Laboratory of Clinical and Translational Studies NIAAA/NIH 10 Center Drive, MSC 1540 Bethesda, MD 20892-1540 ,pWomen and minorities are strongly encouraged to apply. The NIH is. dedicated to building a diverse community in its training and employment programs.

Contact email address: broseberry@cartermackay.com - 14th Feb 2010 [1847]

Director, Preclinical DMPK services

My client is a mid-large size CRO in midwestern US. They are looking for a PhD with strong background in preclinical DMPK and also in the management of atleast 5 scientists. Will be responsible for planning, coordinating, and directing client contracted programs for R&D. Will be responsible for quality and timeline adherence of client contractual obligations. Will prepare technical reports and papers as well as be in charge of laboratory budget. Requirements include a PhD with atleast 6 years of experience in industry and must have CRO experience. Must be able to design and interpret study results and have excellent communication skills and leadership abilities.

Contact email address: jchapman@haallc.com - 9th Feb 2010 [1846]

Description -In this role, you will lead design of clinical pharmacology studies as well as analysis, interpretation, and reporting of PK, drug disposition, and drug metabolism data from clinical studies for compounds and biologicals in therapeutic areas of immunology and oncology utilizing state of the art technology in support of clinical development plans. -You will perform PK and PK/PD modeling, contribute to PK related regulatory documents and draft PK sections in support of clinical development plans, and provide PK perspective on cross functional teams. -You will also participate in regulatory interactions as needed as well as evaluate feasibility of clinical studies and provide input to the design and review of clinical protocols. -In addition, you must maintain a high proficiency on the latest scientific literature in the areas of drug metabolism, PK, PK/PD and clinical pharmacology. -You will also serve as a mentor to junior level PK scientists

Qualifications -Requirements for this position include a PhD or a PharmD with a postdoctoral fellowship training in PK, Biopharmaceutics or a related field with a minimum of three years experience in PK, PK/PD and drug metabolism techniques industry experience is preferred. -Experience in designing, conducting and interpreting studies in PK, population PK, PK/PD correlations, modeling and simulation utilizing state of the art applications is highly desirable. -Candidate must display strong written and oral communication skills necessary to deliver scientific presentations. -The ability to work in a dynamic team oriented environment as demonstrated by participating in and contributing to cross functional teams is necessary.

All interested and qualified candidates please send your CV to jchapman@haallc.com

Contact email address: klausco@verizon.net - 8th Feb 2010 [1845]

Clinical Project Manager – Clinical Pharmacology Allergan Pharmaceuticals Location: Irvine, CA

JOB SUMMARY: With minimal supervision, responsible for providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to multiple drug development programs. Responsible for clinical PK/PD study design, protocol preparation, management, execution, data analysis and study report preparation. Responsible for managing the activities of personnel associated with conducting the Clinical PK/PD studies and assurance of compliance with Allergan SOPs, and FDA and ICH regulations. Responsible for preparation of PK/PD components of Briefing Documents, INDs and NDAs. Also responsible for effective communication within the corporation (and with external organizations, where appropriate) of the issues and actions related to the successful completion of these projects. Provides PK/PD input to the strategic development plans for multiple drug development programs. May serve as the clinical representative to the global development team, as the development project team clinical operations sub-team leader or as a team leader of the global development team.

MINIMUM REQUIREMENTS Education and Experience * PhD/PharmD/MD/OD/DO with 6 years pharmaceutical industry or clinical medicine experience with extensive training in pharmacokinetics, pharmacodynamics and data analysis. Five years of Phase I clinical trial experience or equivalent; or * Master’s degree with 9 years pharmaceutical industry or clinical medicine experience with extensive training in pharmacokinetics, pharmacodynamics and data analysis; minimum two years Phase I clinical research/development experience or * Bachelor’s degree with 11 years pharmaceutical industry or clinical medicine experience with extensive training in pharmacokinetics, pharmacodynamics and data analysis; minimum two years Phase I clinical research/development experience. Essential Skills and Abilities * Knowledge of drug development process and ability to design and implement Clinical Pharmacology development plans. * Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including site monitoring), regulatory compliance (including individual global/country directives/regulations as necessary) and statistical reporting including demonstrated, ongoing application of these knowledge domains to current studies for which the CRM is responsible. Please send your resume to Jennifer Fisher, Staffing consultant Allergan Inc. klausco@verizon.net

External website http://www.allergan.com

Contact email address: timothy.symes@novartis.com - 3rd Feb 2010 [1844]

Principal Scientists, PK/PD – Clinical and Non-Clinical - Basel, Switzerland (www.basel.ch/en) (Novartis Global HQ - business language is English - Novartis assists relocation costs and work permits)

Novartis is a GREAT place to be – 30 new product approvals in the US/Europe/Japan in 2009, a full pipeline, and 145 projects in pharmaceutical clinical development including 60 that involve new molecular entities.

The Novartis Institutes for BioMedical Research is fundamental to this success with research focussed on signalling pathways rather than individual genes and proteins. Working for NIBR in Basel is particularly rewarding - the campus is outstanding with best-in-class architecture and design delivering a state-of-the-art workplace.

We are hiring strong PK/PD talent to join our Drug Metabolism and Pharmacokinetics unit to drive forwards and manage new change initiatives for the understanding and application of PK/PD.

You'll work across DMPK nonclinical and clinical groups to embed PK/PD into groups and projects, liaising with Modelling & Simulation and other functions supporting PK/PD. You’ll deliver PK/PD expertise in drug discovery/early development and later throughout the entire continuum of development - actively involved in all projects, prepare submissions and responses to Health Authorities, leading line function sub-teams

Interested to hear more for you or someone you know? Drop me an email or look for the job descriptions 52882 and 50566 on our career site

Only able to work in the US? We're also hiring in New Jersey (East Hanover)

External website http://www.nibr.com/careers/

Contact email address: gemick@comcast.net - 2nd Feb 2010 [1841]

SENIOR RESEARCH INVESTIGATOR Location: Lawrenceville, New Jersey

Job Responsibilities:

Qualifications:
Contact email address: Dorothy.Kinney@rightthinginc.com - 1st Feb 2010 [1840]

Title: Scientist I/II MD, Gaithersburg - Corporate Headquarters Req: 02216

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.

Major Duties and Responsibilities : * Analyze, interpret and report pharmacokinetic and pharmacodynamic data from pre-clinical and clinical studies *Analyze, interpret and prepare toxicokinetic study reports * Perform population PK and PK/PD analysis and simulation * Help Senior PK PD team members prepare data sets, posters, publications, PK and PD analysis for execution of project deliverables * Prepare PK, PK/PD and population PK components of investigators brochure, study protocols, study reports, project summaries and development plans * Perform PK/PD analysis and simulations for prediction of pre-clinical and clinical PK and dosing * Investigate relationship between PK and clinical effects, biomarkers and side-effects * Able to work cross-functionally with other MedImmune departments including Research, clinical testing, 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 Health Authority Inquiries on PK and PK/PD related issues * Prepare and review scientific publications, posters and abstracts. Special Skills/Abilities: * Candidate should possess good understanding of pharmacokinetic and pharmacodynamic principles * Candidate should have hands-on experience in population PK/PD modeling and simulation using NONMEM * Candidate should have worked with WinNonlin or other PK and PK/PD software. * Interest in planning, designing, interpreting and reporting of preclinical and clinical pharmacokinetic and pharmacodynamic studies including population PK/PD modeling is essential * Strong analytical and critical thinking skills * Strong written and oral communication skills and interpersonal skills are essential

Job Complexity: Ability to evaluate, analyze and interpret standard and complex pharmacokinetic and pharmacodynamic data from pre-clinical and clinical studies in order to aid rational and informed decision making in drug development at MedImmune.

Education: Candidates with a Ph.D (or equivalent) degree in pharmacokinetics, biopharmaceutics or related field

Experience: At least 0-4 years of pharmacometrics experience in pharmaceutical industry or regulatory agency. Hands-on experience in modeling (preferably, with NONMEM) and programming skills (preferably, in S-Plus, R or SAS) are desired

Apply online at www.medimmune.com/careers Req #. 02216

External website http://www.medimmune.com/careers

Contact email address: telder@greylock-recruiting.com - 31st Jan 2010 [1839]

Director of Clinical Pharmacology and Pharmacokinetics. Please contact recruiter for more info. 1 direct report. This position will be dealing in multiple therapeutic areas. Experience in pre-clinical or nonclinical pharmacokinetics as well as experience in clinical PK and pharmacology is strongly desired. PhD required. 5-10 years of experience required. Please contact TJ Elder 617-680-1952.

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

20th Jan 2010 [1838]

Research Investigator II
Requisition No. 60863BR
Novartis Institutes of BioMedical Research
Emeryville, CA

About Novartis Institute of Biomedical Research:
At Novartis Institutes for BioMedical Research (NIBR), the global research organization of Novartis, we are committed to discovering innovative medicines to cure disease and improve human health. By hiring the best academic, biotech, and pharmaceutical trained scientists, we have fostered an atmosphere for drug discovery where innovation is rewarded. It is ultimately the talent of the individual that determines our success, while our state-of-the-art technologies and resources enable these ideas to be realized.

We are looking for a highly qualified Ph.D. level scientist in the area of Pharmacokinetics. The successful candidate will:



To apply for this position, please visit http://www.novartis.com, click on the Careers tab, select Job Search US, then select the link for Novartis Institutes for BioMedical Research (NIBR) in Emeryville, CA and click on the link for Requisition No. 60863BR.

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

Contact email address: chao.c.chen@gsk.com - 20th Jan 2010 [1837]

GlaxoSmithKline (GSK) has an opening for a Senior/Principle Scientist in the Clinical Pharmacology Modelling & Simulation Department in Harlow (UK) or Verona (Italy). Driving the success of GlaxoSmithKline - one of the world's leading pharmaceutical organisations - is a continual search for innovation. In addition to the research and development capability that sets the benchmark for our industry, we're committed to recruiting and retaining the best and brightest by providing unequalled career development opportunities within the organisation.

Due to an increased commitment of GSK to the application of pharmacokinetics/pharmacodynamics (PK/PD), we now have an opportunity within our Clinical Pharmacology Modelling & Simulation Department. As a member of this department, you'll be part of a team exploring, learning and utilising state-of-the-art methodologies to enhance the understanding of PK/PD characteristics of compounds in the GSK portfolio. What's more, you'll be working across the GSK drug pipeline from pre-candidate selection through post-licensing within therapeutically-aligned groups.

By designing clinical PK and PD studies, participating in drug development teams, inputting into clinical development plans, conducting mathematical and statistical modelling of population PK/PD data and writing the critical components of regulatory documents, you will be the public face of Clinical Pharmacology Modelling & Simulation within and outside GSK. With a PhD in Pharmacokinetics, Biopharmaceutics or a related field, an established track record in effectively applying clinical pharmacology principles and pharmacometric methodologies using NONMEM, S-PLUS, and/or other relevant tools, you'll have a sound understanding of clinical pharmacology and the role of PK and modelling in drug development. You need to have excellent written and verbal communication skills and be comfortable forming close and effective relationships with your colleagues throughout the business.

At GlaxoSmithKline we provide a supportive working environment, and a range of development challenges and opportunities. We also offer highly competitive benefits and compensation packages designed to attract and retain the very best talent.

If you are interested in this position please visit www.gsk.com/careers quoting Req ID 57392. Should you require more information about the position please contact Chao Chen: chao.c.chen@gsk.com.

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

Contact email address: gemick@comcast.net - 15th Jan 2010 [1836]

SENIOR RESEARCH INVESTIGATOR

Description -In this role, you will lead design of clinical pharmacology studies as well as analysis, interpretation, and reporting of PK, drug disposition, and drug metabolism data from clinical studies for compounds and biologicals in therapeutic areas of immunology and oncology utilizing state of the art technology in support of clinical development plans. -You will perform PK and PK/PD modeling, contribute to PK related regulatory documents and draft PK sections in support of clinical development plans, and provide PK perspective on cross functional teams. -You will also participate in regulatory interactions as needed as well as evaluate feasibility of clinical studies and provide input to the design and review of clinical protocols. -In addition, you must maintain a high proficiency on the latest scientific literature in the areas of drug metabolism, PK, PK/PD and clinical pharmacology. -You will also serve as a mentor to junior level PK scientists

Qualifications -Requirements for this position include a PhD or a PharmD with a postdoctoral fellowship training in PK, Biopharmaceutics or a related field with a minimum of three years experience in PK, PK/PD and drug metabolism techniques industry experience is preferred. -Experience in designing, conducting and interpreting studies in PK, population PK, PK/PD correlations, modeling and simulation utilizing state of the art applications is highly desirable. -Candidate must display strong written and oral communication skills necessary to deliver scientific presentations. -The ability to work in a dynamic team oriented environment as demonstrated by participating in and contributing to cross functional teams is necessary. -Experience in building an internal network of collaborators is desired

Contact email address: contcsc@optonline.net - 14th Jan 2010 [1835]

Senior Scientist/Principal Scientist:DMPK

Overview: Our client is looking for a scientist with PK/PD expertise to be part of the multidisciplinary small molecule drug discovery program. 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:

Requirements:
Contact email address: jchapman@haallc.com - 12th Jan 2010 [1834]

In these roles, you will lead the design, analysis, interpretation and reporting-of pharmacokinetic, drug disposition, and drug metabolism data from clinical studies for compounds in therapeutic areas utilizing state of the art technology in support of clinical development plans. You will perform pharmacokinetic and pharmacodynamic modeling, contribute to PK related regulatory documents and draft PK sections in support of clinical development plans, and provide PK-perspective on cross functional teams. You will also participate in regulatory interactions as needed as well as evaluate feasibility of clinical studies and provide input to the design and review of clinical protocols. In addition, you must be at the forefront of scientific literature in the areas of clinical pharmacology, modeling – simulation and pharmacokinetics pharmacodynamics. You will also serve as a mentor to junior level PK scientists. The level of experience will determine the title of the position ranging from Sr. Scientist to Director level.

Job Requirements Requirements depend on the position that is being pursued. Sr. Scientist level 0-3 years, Prin. Scientist 3-5, Associate Director 5-10, and Director 10 plus years of industry experience in the areas of Clinical Pharmacology, Pharmacokinetics / Pharmacodynamics, and or Modeling & Simulation.

Location for all of the roles is the North East. All interested and qualified Candidates please your CV to jchapman@haallc.com .

Contact email address: contcsc@optonline.net - 11th Jan 2010 [1833]

Associate Director Pharmacokinetics

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 is required. Prior experience with IND’s, BLA’s and/or NDA’s is highly desirable.

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: dferre15@its.jnj.com - 8th Jan 2010 [1832]

Johnson & Johnson Pharmaceutical Research & Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Scientist, Advanced Modeling and Simulation (AM&S), located in Raritan or Titusville, NJ (USA).

The Scientist conducts advanced PK/PD modeling research utilizing available modeling techniques, with a focus on Oncology compounds. Primarily supports regulatory filing activities by defining the dose-concentration-pharmacological effects relationships of drugs using modeling and simulation methodologies, from data acquired at various development stages. Performs population PK and PK/PD analysis for regulatory submission of Oncology compounds. Uses state-of-the-art computer simulation techniques to predict various possible trial outcomes aimed at optimizing trial designs. Has technical responsibility for organizing, executing, and reporting modeling and simulation research. Collaborates with colleagues and groups within or outside AMS as needed and, under supervision, is responsible for executing technical analyses pertaining to his/her field.

This position requires a MS with 3 or more years of relevant industry experience in Pharmaceutical Sciences, (Clinical) Pharmacology, Physiology or Chemical/Biomedical Engineering or a PhD with at least 2 years of post-doctoral or pharmaceutical development experience in the various aspects of modeling and simulation. This preferably includes hands-on experience with the population approach in describing PK/PD systems with clinical pharmacology data. A working knowledge of preclinical or clinical pharmacokinetics, drug metabolism, PK/PD modeling principles and statistics is required. Experience with NONMEM, SPLUS, R and/or other modeling and simulation software is strongly preferred. Has a keen interest in planning, conducting, evaluating and reporting PK/PD studies. Good communication and interpersonal skills are essential. Ability to work in a team environment is a must. Experience in late development projects in Oncology would be an asset.

requisition # 7092091202 — Scientist AM&S

External website http://www.jnj.com/careers

Contact email address: dferre15@its.jnj.com - 8th Jan 2010 [1831]

Johnson & Johnson Pharmaceutical Research & Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Research Fellow AM&S, located in Raritan or Titusville, NJ (USA).

The Research Fellow independently conducts advanced PK/PD modeling research with emphasis on disease progression modeling and implementation of systems biology and mechanism-based approaches. Supports product development by defining the dose-concentration-pharmacological effect relationships of drugs using modeling and simulation methodologies from data acquired at various stages of drug research and development, and basic and clinical disease research, with a focus on Oncology compounds. Performs population PK and PK/PD analysis for regulatory submissions. Uses state-of-the-art computer simulation techniques to formulate various clinical trial design scenarios and outcome analyses. Has full technical responsibility for interpreting, organizing, executing, and coordinating assignments. Conceptualizes, plans, develops and executes R&D projects that have a major impact on key development programs.

PhD or equivalent in Pharmaceutical Sciences, Clinical Pharmacology or Chemical/Biomedical Engineering is required. The successful candidate has preferably a minimum of 12-15 years of pharmaceutical development experience in the various aspects of modeling and simulation. This preferably includes hands-on experience with the population approach in describing PK/PD systems with various types of clinical pharmacology data, coaching junior staff, identifying research projects and successfully managing them in collaboration with internal or external teams. In-depth knowledge of preclinical or clinical pharmacokinetics, drug metabolism, PK/PD modeling principles and statistics are required. The successful candidate has experience with NONMEM, SPLUS and/or other modeling and simulation software is required. A thorough experience in planning, conducting, evaluating and reporting PK/PD studies in an R&D environment is a must. Excellent communication and interpersonal skills. Ability to work in a team environment. Good presentation and reporting skills are required. Good supervisory experience is a plus.

External website http://www.jnj.com/careers

Contact email address: jennyx@hmplglobal.com - 30th Dec 2009 [1827]

Hutchison MediPharma Limited (HMPL) is a leading biotechnology company in China. It was founded in Shanghai's 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.

External website http://www.hmplglobal.com

Contact email address: reggie.arjungi@regeneron.com - 22nd Dec 2009 [1824]

Regeneron Pharmaceuticals

Req Number: 1760 Title: QC Associate IV/V - PK/PD Division: Development Location: Tarrytown, N.Y.

Description: The ideal candidate will have a BS/BA or MS/MA degree in a biological or related science with 2-8+ experience in a QC function. Computer proficiency with Excel and Word required. Experience with GLP and GLP documentation required; LIMS experience a plus. Candidate must have experience supervising other individuals. Detailed documentation skills a must. Duties as follows: - QC of all notebook documentation, sample analysis reports, summary reports, LIMS labels for accuracy - 100% - Supervision of other QC associates - 100%

Experience: TECHNICAL SKILLS: Oral, written communication skills; computer skills; Experience with GLP and GLP documentation OTHER SKILLS: Individual is responsible for QCing all notebook documentation, sample analysis reports, summary reports, LIMS labels for accuracy. Experience with GLP and GLP documentation required; LIMS experience a plus. Supervisory experience required. Detailed documentation skills

External website http://www.regeneron.com

Contact email address: reggie.arjungi@regeneron.com - 22nd Dec 2009 [1823]

Regeneron Pharmaceuticals

Req Number: 1762 Title: Staff Scientist/Senior Staff Scientist - PK/PD Division: Development Location: Tarrytown, N.Y.

Description: We are looking for a candidate with a PhD in Biology, Chemistry, Immunology, Biochemistry or related areas with at least 7 years of laboratory experience. The candidate must have a demonstrated ability to work independently and in a team environment. Clear and candid oral/written communication skills are required as is knowledge and hands-on experience with immunoassays (ELISA-based). Animal handling techniques are demanded, i.e. animal handling, dosing via numerous routes, blood and tissue sampling and data collection analysis and interpretation. Knowledge of GLPs is required. The candidate must also pay good attention to details and demonstrate excellent record keeping skills. The candidate should have good communication skills. Computer proficiency (Word, Excel, etc.) is expected and experience with Softmax and LIMS is a plus. Responsibilities are as follows: - Sample Analysis 75% - Animal Handling and PK Sample Collection - 5% - Data Entry, Report Writing - 20%

Experience: TECHNICAL SKILLS: - Experience supervising research associates - Experience analyzing/conducting PK studies (Experience working with rodents including dosing and sample collection) - Experience analyzing toxicology samples - Extensive working knowledge and experience in ELISA-related immunoassay - Experience writing sample analysis reports, ND and BLA sections - Literate with knowledge of Word, Excel, and Power Point - LIMS experience - GLP experience OTHER SKILLS: Specific include a demonstrated ability to work independently, conduct biological experiments, and to analyze biological data. Good communication skills and ability to work effectively in a team environment; knowledge of GLP regulation is a plus. Experience with report writing.

External website http://www.regeneron.com

Contact email address: reggie.arjungi@regeneron.com - 22nd Dec 2009 [1821]

Regeneron Pharmaceuticals

Req Number: 1759 Title: Research Associate I/II/III PK/PD Division: Development Location: Tarrytown, N.Y.

Description: We are looking for a candidate with minimum BS in Biology, Chemistry, Immunology, Biochemistry or related areas with 0-8 years of laboratory experience. A MS in Pharmacology or Pharmaceutical Sciences major would be ideal. The candidate must have a demonstrated ability to work independently and in a team environment. Clear and candid oral/written communication skills are required as is knowledge and hands-on experience with immunoassays (ELISA-based). Animal handling techniques are demanded, i.e. animal handling, dosing via numerous routes, blood and tissue sampling and data collection analysis and interpretation. Knowledge of GLPs is required. The candidate must also pay good attention to details and demonstrate excellent record keeping skills. The candidate should have good communication skills. Computer proficiency (Word, Excel, etc.) is expected and experience with Softmax and LIMS is a plus. Responsibilites as follows: - Sample Analysis - 72% - Animal Handling and PK Sample Collection - 5% - Data Entry - 5% - GLP Compliance and record keeping - 15% - Reagent Prep - 3%

Experience: TECHNICAL SKILLS: - Extensive working knowledge and experience in ELISA-related immunoassay - Experience working with rodents including dosing and sample collection - Literate with knowledge of Word, Excel, and Power Point - LIMS experience - GLP experience

OTHER SKILLS: Specific include a demonstrated ability to work independently, conduct biological experiments, and to analyze biological data. Good communication skills and ability to work effectively in a team environment; knowledge of GLP regulation is a plus.

External website http://www.regeneron.com

Contact email address: reggie.arjungi@regeneron.com - 22nd Dec 2009 [1820]

Regeneron Pharmaceuticals

Req Number: 1757 Title: Research Associate III-IV PK/PD Division: Development Location: Tarrytown, N.Y.

Description: We are looking for a candidate with minimum BS in Biology, Chemistry, Immunology, Biochemistry or related areas with 0-8 years of laboratory experience. A MS in Pharmacology or Pharmaceutical Sciences major would be ideal. The candidate must have a demonstrated ability to work independently and in a team environment. Clear and candid oral/written communication skills are required as is knowledge and hands-on experience with immunoassays (ELISA-based). Animal handling techniques are demanded, i.e. animal handling, dosing via numerous routes, blood and tissue sampling and data collection analysis and interpretation. Knowledge of GLPs is required. The candidate must also pay good attention to details and demonstrate excellent record keeping skills. The candidate should have good communication skills. Computer proficiency (Word, Excel, etc.) is expected and experience with Softmax and LIMS is a plus. Responsibilites as follows: - Sample Analysis - 72% - Animal Handling and PK Sample Collection - 5% - Data Entry - 5% - GLP Compliance and record keeping - 15% - Reagent Prep - 3%

Experience: TECHNICAL SKILLS: - Extensive working knowledge and experience in ELISA-related immunoassay - Experience working with rodents including dosing and sample collection - Literate with knowledge of Word, Excel, and Power Point - LIMS experience - GLP experience Other Skills include: Specific include a demonstrated ability to work independently, conduct biological experiments, and to analyze biological data. Good communication skills and ability to work effectively in a team environment; knowledge of GLP regulation is a plus.

External website http://www.regeneron.com

Contact email address: reggie.arjungi@regeneron.com - 22nd Dec 2009 [1818]

New Job Opening: Research Associate PK/PD (Regeneron Pharmaceuticals) Click the link to view job description: Qualified candidates – email your resume to reggie.arjungi@regeneron.com *In the subject line write: Response to posting on B – job number 1761

External website https://sh.webhire.com/servlet/av/jd?ai=874&ji=2411859&sn=I

Contact email address: contcsc@optonline.net - 17th Dec 2009 [1817]

Lead the clinical pharmacology development of therapeutic 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. Responsible for the development 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. Supervise 1-2 PhD level scientists. Responsible for the preparation of the Clinical Pharmacology components of regulatory submissions and responding to regulatory authority questions. Serve as a clinical pharmacology expert across the organization and to regulatory agencies. Represent the department 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 or equivalent. 8+ years relevant 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, data interpretation, review and reporting of results. Experience developing a clinical pharmacology plan. Demonstrated experience in preparing regulatory submissions. Experience responding to regulatory questions related to pharmacokinetics and pharmacodynamics. . Leadership skills with a successful track record as a direct supervisor, mentor and developer of people. 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: tycho.heimbach@novartis.com - 16th Dec 2009 [1816]

Postdoctoral Fellow (Nonclinical PK/PD Section/DMPK) Novartis Job ID# 57452BR

NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH EAST HANOVER, NEW JERSEY USA

Welcome to Novartis – the company that considers its employees to be its greatest asset. Good Business. Great Opportunities. Novartis is a world leader in the research and development of products that protect and improve health and well-being. Its core businesses are pharmaceuticals, vaccines, consumer health, generics, eye care, and animal health. Globally Novartis employs approximately 101,000 people in more than 140 countries. Its global headquarters are located in Basel, Switzerland and its US headquarters are in New Jersey. We’re part of a team that’s making a difference in the quality of people’s lives. Think What’s Possible.

JOB DESCRIPTION: This position will be responsible for interacting with project teams within our DMPK function to establish PK/PD models. Modeling using WinNonlin, NONMEM and/or other appropriate simulation tools e.g. GastroPlus is highly desired. The successful candidate will design, conduct and interpret PK and PK/PD studies to build preclinical and clinical PK/PD models for the projection of early efficacious human dosing regimen. Primary responsibilities also include the development and validation of PBPK and PBPK/PD models and development of modeling strategies. The candidate will routinely advise drug development teams on PK/PD related issues for oral and non-oral delivery routes.

MINIMUM REQUIREMENTS: Ph.D. degree in pharmacokinetics, biopharmaceutics, biomedical engineering, chemical engineering, or other related discipline with specific experience in PK/PD and/or PK modeling with 0-3 years required. The candidate must be able to work independently and have a strong understanding of PK/PD. The candidate should should be able to provide technical assistance on individual projects, spanning across multiple therapeutic areas. Hands-on experience in PK and PK/PD modeling is a must. Good oral and written communication skills are required. Previous experience with some of the PKPD softwares such as: WinNonlin; ADAPT; NONMEM, GastroPlus.

JOB APPLICANTS: Please send CV and cover letter to Tycho Heimbach, Ph.D at Tycho.Heimbach@novartis.com, through the Novartis on-line career center (reference Novartis JobID#).

Contact email address: btsuji@buffalo.edu - 15th Dec 2009 [1815]

POST-DOCTORAL POSITION IN PHARMACOMETRICS & INFECTIOUS DISEASES

The School of Pharmacy and Pharmaceutical Sciences of the University at Buffalo is offering a post-doctoral fellowship in the area of pharmacokinetics and pharmacodynamics focusing on infectious diseases. Our group offers a stimulating environment with world-class training both in mathematical modeling and infectious disease experimentation. The candidate has the opportunity to perform in vitro studies directed toward the characterization of antimicrobial pharmacodynamics and to evaluate these and other data via population PK/PD modeling and simulations.

The position will be available for one year with the option of a one year extension assuming mutual agreement. The candidate must be a prospective or recent recipient of a Ph.D., M.D., Pharm.D., or equivalent degree in a relevant subject area (incl. infectious diseases, pharmaceutics, PK/PD modeling, biostatistics). The successful candidate should have a strong willingness to learn new experimental and modeling techniques. Hands-on experience with PK or PK/PD modeling or antibacterial in vitro studies will be a plus. Both US and international candidates are welcome to apply.

Please email Brian Tsuji, Pharm.D. your curriculum vitae, letter of interest, a time window for potential starting dates, and names, email addresses, and phone numbers of three references. Email: btsuji@buffalo.edu.

Please email me for further information and questions. Best regards Brian Tsuji & Alan Forrest

Contact email address: bsantos-research@ferrergrupo.com - 15th Dec 2009 [1814]

We are a leading pharmaceutical company with several research centers throughout Europe. Our company focuses on the discovery and development of innovative medicines in the area of cardiovascular, central nervous system, infectious diseases, dermatology and inflammation.

We offer a SENIOR POSITION IN PHARMACOKINETICS & METABOLISM: Tasks: Development and validation of analytical methods related to bioanalysis and metabolism (discovery, development and clinical) . Technical skills: PhD in chemistry, pharmacy with experienced in regulatory submissions, with additional knowledge on the computational tools for bioanalysis and automatization of process of bioanalysis.

All the candidates should be fluent in the English language. Knowledge of Spanish, although useful, is not a requirement.

The position is based in Barcelona a beautiful city located in the north-east part of Spain which is known for its beautiful architecture, Mediterranean climate and cuisine, beautiful beaches and the Pyrenees mountains.

In addition to working in a thriving environment with an experienced and professional team and salaries commensurate with the requirements and status of these positions, our benefit package includes Spanish government sponsored retirement plan, free medical insurance, unemployment plan and assistance with relocation where appropriate.

To apply, please send a Curriculum Vitae along with a cover letter to bsantos-research@ferrergrupo.com, To apply by E-mail or internet.

Benjamin Santos Lobo PhD Head of Departament Pharmacokinetics and Metabolism R&D Center. Ferrer Internacional S.A. 08028 Juan de Sada 32 Barcelona Tel +34 93 5093230 Fax +34 93 4112764 bsantos-research@ferrergrupo.com www.ferrergrupo.com

Contact email address: broseberry@cartermackay.com - 9th Dec 2009 [1813]

Principal Investigator/Associate Director, PK/PD

There are two separate positions with a mid size pharmaceutical company with strong financial backing and pipeline stability. The main purpose of the successful candidate will be to design, implement, and interpret PK/PD and PK/ADME studies as well as bioanalytical data. Also required is the ability to perform and interpret in vivo and in vitro data to assess study compound properties. This data will be used by the successful candidate to perform PK/PD analysis, modeling and simulation, and human dose predicition. The Principal Investigator/Assoc. Director will be expected to work in a matrix team environment, collaborate with partner companies, and provide input for the selection of drug candidates for development.

There will also be required contribution to regulatory documents such as IND’s and NDA’s. This position will have direct reports and encompass both GLP and non-GLP studies. This position provides work in both preclinical development and early clinical studies, especially as it pertains to modeling and simulation with WinNonLin, NONMEM, ADAPT, and SAAMI.

Requirements include a PhD degree in Pharmacokinetics or related field with at least 5 years of industry experience in establishing PK/PD relationships. Also required is a strong knowledge of PK/ADME science as it pertains to drug development. Must have experience in PK modeling with software such as WinNonLin, NONMEM, etc.This individual must have strong leadership and communication skills, be self motivated, and be able to multitask. Prior experience in filing IND’s, NDA’s, or BLA’s is strongly desired

If interested, please contact broseberry@cartermackay.com/315-635-1227

Contact email address: gemick@comcast.net - 20th Nov 2009 [1812]

Principal Scientist-Associate Director Clinical Pharmacology PK-PD State: Delaware Department: Clinical Pharmacology

Responsibilities:

Education and Experience: Skills and Capabilities: Reporting Relationships:
Contact email address: rocco.dimarinis@laxai.com - 17th Nov 2009 [1811]

Senior Clinical Scientists/Clinical Pharmacologists positions with major northeastern pharmaceutical firm.PhD, PharmD, MD with working knowledge of various approaches to PK and PD data analysis. Population data analysis knowledge and appropriate computer software experience e.g., MS Word, Excel, PowerPoint, WinNonlin. Knowledge of Splus, Spotfire and NONMEM a plus. An overall knowledge of ICH GCP and the drug development process is required.

Will be responsible for the planning, management, data evaluation and reporting of clinical pharmacology studies .Incumbent will provide scientific input for final study reports and annual report documentation, and assist in high-level IND and NDA documentation process.

Resumes to: Rocco DiMarinis Director Resource Management www.laxai.com rocco.dimarinis@laxai.com 908.756.7300 Ext 304

Contact email address: gemick@comcast.net - 12th Nov 2009 [1809]

Director, Clinical Pharmacology-CV/MET # 28380 Location:Lawrenceville: New Jersey Description and Responsibilities:

Requirements:
Contact email address: broseberry@cartermackay.com - 10th Nov 2009 [1808]

Director, Modeling and Simulation Northeastern United States

Job Summary: Ensure current methods in modeling and simulation is used during preclinical and clinical development to support product development and decision making. Responsibilities:Develop and execute M&S plans for development compounds that contribute to dose selection, sample size power, sampling scheme, issue resolution and decision making in conjunction with Translational Medicine, Clinical Pharmacology and Clinical Development.Conduct key model based analyses and interact with external partners to conduct these analyses. Develop innovative study designs for translational medicine and clinical pharmacology studies.Partner with Bioinformatics. Will also support model based predictions of human pharmacokinetics and pharmacodynamics based on preclinical data. Job Requirements

Ph.D. in Pharmaceutical sciences or equivalent.Minimum requirement 6 years clinical pharmacology and pharmacokinetics experience.Must have up to date hands on expertise in modeling and simulation..In-depth knowledge of current regulatory requirements (FDA, GCP and ICH).Ability to work independently and to effectively prioritize, proactively identify and resolve problems and work in a team environment.Must possess excellent communication and interpersonal skills.Demonstrated experience in population pharmacokinetic-pharmacodynamic modeling required using NONMEM. Experience in clinical trials simulation desirable. About 15% planned travel. Interested and qualified candidates only, please contact broseberry@cartermackay.com or call 315-635-1227.

Contact email address: klausco@verizon.net - 6th Nov 2009 [1807]

Scientific Director, Clinical Pharmacokinetics and Pharmacodynamics (PK Modeling Guru)

Allergan is a global, technology-driven multi-specialty health care company pursuing therapeutic advances to help patients live life to their fullest potential.

Responsibilities: Direct and conduct highly sophisticated research requiring the application of advanced knowledge in clinical pharmacokinetics, drug metabolism, pharmacodynamics, modeling, and clinical trial simulation. Prepare and review registration summaries for corporate and regulatory registrations; play a major role in training, motivating, developing, and mentoring junior CPK staff. Help identify clinical pharmacology goals and formulate global development plans to support R&D needs. Incumbent functions in a matrix/team setting, oversees and coordinates activities performed by technical and clinical staff in multifunctional areas. Direct and implement clinical pharmacology studies that requires the application of advanced knowledge in clinical pharmacokinetics, drug metabolism, pharmacodynamics, modeling, simulation, and state-of-the-art PK/PD software applications Prepare and review clinical pharmacology study reports and registration summaries for corporate and regulatory registrations Develop and implement clinical pharmacology development plan in cross functioning project teams. Establish new department standard operating procedures and guidances. Build and maintain PK/PD and drug metabolism expertise in department. Represents the company and participates in scientific meetings to acquire and share new ideas and to maintain state-of-the-art knowledge in field of specialization. Writes patents, scientific articles and makes presentations at national scientific meetings. Required experience: Ph.D.-level education with a minimum of 15 years of post-doctoral experience National recognition. National recognition to be defined as having achieved one or more of the following: Scientific findings that have the potential to open new markets and market opportunities and will add to the company's technology base Proven experience in drug discovery and clinical drug development Patent applications in the area of specialization Scientific publications in area of specialization

Essential Skills and Abilities Clinical pharmacokinetics, drug metabolism, pharmacodynamics, modeling, and simulation, Demonstrated expertise in using state-of-the-art PK/PD software applications Demonstrated industry experience beginning from drug discovery to clinical drug development Strong experience in interactions with regulatory agencies Please email resume to: Jennifer Fisher klausco@verizon.net or apply online at www.allergan.com

External website http://www.allergan.com

Contact email address: klausco@verizon.net - 6th Nov 2009 [1806]

Clinical Project Manager – Clinical Pharmacology Allergan Pharmaceuticals Location: Irvine, CA

JOB SUMMARY: With minimal supervision, responsible for providing clinical pharmacokinetic (PK) and pharmacodynamic (PD) expertise to multiple drug development programs. Responsible for clinical PK/PD study design, protocol preparation, management, execution, data analysis and study report preparation. Responsible for managing the activities of personnel associated with conducting the Clinical PK/PD studies and assurance of compliance with Allergan SOPs, and FDA and ICH regulations. Responsible for preparation of PK/PD components of Briefing Documents, INDs and NDAs. Also responsible for effective communication within the corporation (and with external organizations, where appropriate) of the issues and actions related to the successful completion of these projects. Provides PK/PD input to the strategic development plans for multiple drug development programs. May serve as the clinical representative to the global development team, as the development project team clinical operations sub-team leader or as a team leader of the global development team.

MINIMUM REQUIREMENTS Education and Experience * PhD/PharmD/MD/OD/DO with 6 years pharmaceutical industry or clinical medicine experience with extensive training in pharmacokinetics, pharmacodynamics and data analysis. Five years of Phase I clinical trial experience or equivalent; or * Master’s degree with 9 years pharmaceutical industry or clinical medicine experience with extensive training in pharmacokinetics, pharmacodynamics and data analysis; minimum two years Phase I clinical research/development experience or * Bachelor’s degree with 11 years pharmaceutical industry or clinical medicine experience with extensive training in pharmacokinetics, pharmacodynamics and data analysis; minimum two years Phase I clinical research/development experience. Essential Skills and Abilities * Knowledge of drug development process and ability to design and implement Clinical Pharmacology development plans. * Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including site monitoring), regulatory compliance (including individual global/country directives/regulations as necessary) and statistical reporting including demonstrated, ongoing application of these knowledge domains to current studies for which the CRM is responsible.

External website http://www.allergan.com

Contact email address: john.rynak@infi.com - 29th Oct 2009 [1805]

Associate Director / Group Lead, Drug Metabolism Location: Cambridge, MA Infinity Pharmaceuticals is an innovative cancer drug discovery and development company that is seeking to leverage its strength in small molecule drug technologies to discover, develop, and deliver to patients first-in-class or best-in-class medicines for the treatment of cancer and related conditions.

Position Deliverables: The position requires an understanding of the theory and practice of in vitro and in vivo drug metabolism studies. The individual, with supervision, will primarily design and perform a variety of drug metabolism studies in support of our drug discovery and development efforts. Hands-on experience with enzyme phenotyping, metabolite structural elucidation, and CYP450 inhibition is strongly desired. Knowledge of pharmacokinetic principles is desirable as the individual may provide support as needed. The successful candidate will be responsible for applying different scientific skills including assay development and LC-MS/MS operation. The selected individual will work closely with DMPK team members to analyze and interpret data which will be presented in a multidisciplinary team environment. Qualities vital to our success include flexibility, open communication, and teamwork.

Position Requirements: * MS/PhD in Analytical Chemistry, Biochemistry or related field with 5-10 years experience. * Extensive experience with a variety of drug metabolism studies, e.g. metabolic stability and metabolite profiling in microsomes, hepatocytes or biological samples from in vivo studies. * Experience in LC-MS/MS operation, method development, maintenance, and troubleshooting. * Strong interpersonal skills. * Strong oral and written communication skills. Interested candidates may apply online at: http://www.infi.com/careers.html

External website http://www.infi.com

13th Oct 2009 [1804]

Job title: Case Medical Evaluator Location: Bridgewater, NJ Client: sanofi-aventis Duration: 5 months min

Duties: ***Contractors will be working on SINGLE CASES. Prefers somone with CME exp. or someone who has freshly completed medical residency in the United States. May consider someone who has completed residency outside of the US. · Medical expert in the Case Management Pharmacovigilance Unit for assigned products. · Medical evaluation of all adverse events for assigned products. · Participate to signal detection for assigned products. · Prompt identification and immediate communication of potential alert reports and safety signals to the Global Safety Officer. Skills: · Individual Case Reviews: For assigned products, reviews all individual adverse event reports for clinical and regulatory assessment. Directs follow-up for serious cases. Approval of all individual case reports to regulatory authorities (all serious/listed/(associated) cases). Identify all SUSAR cases for prompt review by GSO. Identification of potential safety signals and informing Global Safety Officer of all potentially-important cases and issues. · Clinical: assesses cases for clinical implication, enters company case evaluation comment into Clintrace, directs follow-up with relevant units (ASO, URC …). · Supports signal detection/analysis activities with Global Safety Officer.

Education: · MD or PharmD degree preferred. · At least 3 years in Pharmacovigilance, or related experience, preferred. · Excellent teamwork and interpersonal skills. · Good clinical judgement and ability to communicate complex clinical issues in a scientifically sound and understandable way effectively. · Initiative and capability to work under pressure. · Procedures and guidelines SOPs, Working practices). · Database (Clintrace). Sarath K. Nanda Talent Acquisition Lead (SAS/Biostatistics/Clinical Data Management) Tel: 973-481-0100 Ext: 3016 Fax: 973-273-4639 sarath.nanda@makroscientific.com

Candidate HelpDesk : 973-679-5005 “I grow my network through quality referrals from people like you. Do you know anyone who could benefit from my services?” Makro Scientific Life Sciences Staffing Division of Makro Group One Washington Park, Suite 1502, Newark, NJ 07102 www.makroscientific.com Other Offices: Northern California, Pennsylvania, Illinois ** Makro is 3-time INC 5000 company for 2007/2008/2009 ** Makro is 3-time FAST 50 in NJ for 2005/2006/2007 (by Deloitte) ** Makro is 3-time FAST 500 in USA for 2005/2006/2007 (by Deloitte) ** Makro is NJ Finest for 2008 (by NJBIZ)

External website http://www.makroscientific.com/makroscientific/jobs/login.aspx

Contact email address: monica.ko@regeneron.com - 5th Oct 2009 [1802]

Seeking PK Biometrician/Pharmacometrician/PK Scientist

Position Description: Develops of novel pharmacometric, statistical, and mathematical models; applies these and existing models to solve complex scientific statistical and pharmacokinetic and pharmacodynamic problems related to preclinical and/or clinical development, as well as, manufacturing and research.

Essential Functions of the Job (Major Duties and Responsibilities): -Provides consultative pharmacometric and statistical support to scientists. -Develops pharmacometric including population PK/PD models -Analyzes and interprets PK/PD data; Generates tables and listings. Creates derived PK/PD files according to standard specifications. -Writes PK/PD sections of clinical study protocol, statistical analysis plans, clinical study reports, regulatory documents and publications. Provides input for standard operation procedures and best practices. -Assists in training of fellow scientists and statisticians in pharmacometric methods and use of PK/PD software investigating theoretical problems arising out of research.

Required Skills: -Knowledge of statistics including nonlinear mixed effort model and Monte-Carlo simulation, SAS including IML, tabulate and Gplot procedures, differential equations and basic or advanced pharmacokinetics. -Good working knowledge of SAS (Base, Stat, IML, Macro, Graph) programming is required. Knowledge of R/S-Plus graphics is a plus. -Knowledge of basic genetics and microarray data analysis is a plus. -Excellent writing and communication skills; includes presentations to internal scientific and managerial review meetings and to regulatory agencies. -Knowledge of Winnonlin and NONMEM are highly desirable skills for this position.

Education and Experience: -Masters Degree or Ph.D. in statistics, engineering math, computational biology, pharmacy, physics, and/or relavent fiellds is required. -One to three (1-3)years of experience.

If interested, please send your resume immediately for consideration. Also, please apply directly on our career site: www.regeneron.jobs (job#1631) EOE/M/F/D/V

External website http://www.regeneron.jobs

Contact email address: sarath.nanda@makroscientific.com - 24th Sep 2009 [1801]

POSITION TITLE: (Contract) Statistician Location: Madison, NJ Duration: 4-5 months

I. Responsibilities:

II. Qualifications and Experience

Qualification Rating Clinical Advanced Degree * Yes SAS * 1+ Yrs.

External website http://www.makroscientific.com

Contact email address: rehchristian@praintl.com - 24th Sep 2009 [1800]

The Early Development Services (EDS) division of PRA International is a global leader in providing early-phase clinical research and bio-analytical services to the pharmaceutical and biotechnology industries. With a reputation built on excellence, quality and professionalism, we work with leading pharmaceutical and biotechnology companies, performing clinical research and bio-analytical trials on many of the most advanced experimental drugs and biological in development today. Employees of EDS are enthusiastic and dedicated and work in a dynamic informal organization. EDS CEE is a group within Early Development Services focusing on early-phase clinical trials in special patient populations. With management offices in Germany, and clinical operations in several cities across Central Europe, we now have an opening for a

Director Medical Affairs for our Berlin office. As Director Medical Affairs your responsibilities will focus on the medical and scientific management of clinical trials performed in Germany and Central Europe in compliance with local law and GCP principles. You will act as a Global Study Director (GSD) in studies. The successful candidate(s) will have both a clinical and commercial focus, with a real commitment to client satisfaction. Part of the job is to travel to several cities across Central Europe. A life science degree is required, a medical degree would be an advantage. Relevant industry/CRO experience would be beneficial. You should also have a very good command of English. We offer a competitive salary and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale. If you are interested in a dynamic job and career please send your application and resume to CareerEDS@praintl.com. For more information you can contact Kris Strobos, Sr. HR Officer 0031 6 20131273 or visit our website.

External website http://www.praintl.com

Contact email address: joyce.mordenti@medivation.com - 23rd Sep 2009 [1799]

Associate Director / Director, Pharmacokinetics

Join the team at Medivation for an exciting opportunity to take molecules from bench to bedside! Essential functions include but are not limited to the following: ** Evaluate the preclinical and clinical PK, PK/PD, and metabolism properties of small molecule drug candidates ** Collaborate with colleagues in Clinical, Preclinical, Chemistry, Regulatory, and CMC in a team-oriented environment to support programs in all phases of development ** Design, manage, and report preclinical DMPK studies, preclinical PK/TK analyses, and clinical pharmacology studies, including first-in-human studies ** Prepare Nonclinical Pharmacokinetics, Biopharmaceutics, and Clinical Pharmacology sections of regulatory submissions

Position requires PhD, minimum 10 years of related experience beyond post doc, and prior strategic role in progression of drug candidates from bench to bedside. Experience must include design and oversight of human studies, authorship of relevant IND/NDA sections, and company representation at FDA meetings. Hands-on experience with PK/PD modeling and simulation is required; population PK modeling is a plus. The compensation package for this position will be competitive, and consist of base salary, annual bonus opportunity, stock options, and a comprehensive benefits package. Interested candidates are invited to submit their CV and cover letter to hr@medivation.com. Please reference job code 090922PK in subject line.

External website http://www.medivation.com

Contact email address: hr@frontierbsi.com - 22nd Sep 2009 [1798]

Frontier BioSciences, a US-based preclinical Contract Research Organization is currently seeking candidates for their laboratory facility in Chengdu, China. Interested individuals should send their CV to hr@frontierbsi.com, and reference the position they are applying for.

SENIOR QUALITY ASSURANCE AUDITORS – Chengdu, China

Educational and Experience Requirements: Bachelors Degree in a related science (Biology, Chemistry, etc.) and a minimum of 5 years related regulatory/QA experience, preferably in the pharmaceutical/biotechnology industry. Basic understanding of Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs). Good Manufacturing Practices (cGMPs), especially as related to the pharmaceutical/biotechnology industry and the ability to communicate understanding to others. Experience in performing QA/Regulatory Compliance audits. Working knowledge of applicable US-FDA regulations and guidelines to include ICH guidelines. Strong computer skills, i.e., MS Word, Excel, PowerPoint. Excellent verbal and written communication skills; fluency in Chinese highly preferred. US-CRO experience a plus Please see the complete job description on our website.

External website http://www.frontierbsi.com

Contact email address: hr@frontierbsi.com - 22nd Sep 2009 [1797]

Study Director - Preclinical Toxicology

Frontier BioSciences, a US-based preclinical Contract Research Organization is currently seeking candidates for their laboratory facility in Chengdu, China. Interested individuals should send their CV to hr@frontierbsi.com, and reference the position they are applying for.

Qualifications: Masters or Doctoral degree in toxicology or related field or DVM with relevant experience; US-CRO experience a plus; expertise in toxicology, reproductive toxicology, immunology, pharmacology and/or related fields; D.A.B.T. or working toward certification; excellent computer, communication and writing skills; previous publications preferred; ability to work independently.

Please review the complete job description on our website.

External website http://www.frontierbsi.com

Contact email address: jtatone@tpna.com - 17th Sep 2009 [1795]

Takeda San Diego Principal Scientist, DMPK - Takeda San Diego Job Number: 0900370

OBJECTIVES: Serve as DMPK and PK/PD expert to discovery project teams, provide input into research strategies and be involved in collaboration with other Takeda sites in advancing compounds to IND. Provide expertise in area of PK/PD data analysis, interpretation and study design, and to participate in core-level decision-making. This individual will be expected to present, promote and defend their ideas in cross-functional team settings, and influence critical strategic decisions in multiple therapeutic areas

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: Ph.D. or Pharm. D. with emphasis in pharmacokinetics and PK/PD and minimum 8 years of relevant experience, OR MS in life science and minimum 14 years of relevant experience, OR BS in life science and minimum 17 years of relevant experience DMPK Leadership in advancing compounds through discovery into IND-enabling stage Proficiency in PK, PK/PD, PK/efficacy modeling using various software such as WinNonlin and NONMEM Thorough understanding of the commonly used approaches for human PK prediction, and hands-on experience in application to multiple discovery programs Successful experience in predicting human efficacious dose and assisting clinical dosing schedule optimization Experience in the therapeutic areas of Oncology, Inflammation or Metabolic Disease Demonstrated independent thought/creativity in science and success in coordinating and executing research to further corporate goals Demonstrated inter-disciplinary knowledge of drug discovery and ability to use this knowledge to influence project strategy Demonstrated ability to successfully direct multiple scientific endeavors simultaneously High-level technical skills, with demonstrated application and creativity Excellent communication, collaboration and multitasking skills and ability to work in a team setting High degree of scientific discretion/intuition Conveys ideas in an experimentally detailed yet scientifically concise manner Demonstrated proficiency at presentation of original work at conferences Competent in authorship of peer-reviewed scientific papers

We are an equal opportunity employer. www.tpna.com www.takedasd.com No Phone Calls or Recruiters Please. Feel free to send your resume directly to jtatone@tpna.com as well!

External website http://www.takedasd.com

Contact email address: broseberry@cartermackay.com - 17th Sep 2009 [1794]

Director, PD-Biomarker and Immunology. My West Coast Client is an international leader in biotechnology. They are looking for a PhD or MD or MD/PhD to lead their Immunology Pharmacodynamic Biomarker dept. This dept. is within the Translational Pharmacology and early development group. The successful candidate will lead a large group of research associates and scientiststo successfully integrate PD-Biomarkers strategies and assays into their preclinical and clinical development programs in the areas of Immunology, Infectious Diseases, Neurology, Tissue Growth and Repair. He/She will provide scientific leadership to develop PD-biomarker strategies and novel assays to determine drug MOA, activity and relevant biological effects in patients. This candidate will be expected to form close collaborations with research Discovery, Diagnostics, Clinical ITGR, Safety and PKPD groups.

Primary responsibilities are as follows: Provide scientific leadership for the company's Pharmacodynamic-Biomarker strategies for all non-oncology projects. Advance the understanding of the pharmacology of drugs and disease and integrate PD-markers into our drug development programs when and where appropriate. The Director will provide scientific advice regarding PD-Biomarkers to Peer Review Committees and Senior Leadership, as well as optimize to use of biomarker programs.

Requirements: PhD or M.D./PH.D. in a relevant scientific field (e.g. Immunology, Pharmacology, Pathology, Molecular biology). A strong knowledge of PD biomarkers and their use in defining PK/PD and dose-response relationships is desireable.A minimum of eight (8-10) years experience in basic, clinical or industrial research post PhD. A strong publication record is required as is the ability to build, lead and manage a large group of highly motivated scientists. Qualified individuals please send your resume to broseberry@cartermackay.com or call Brenda Roseberry at 315-635-1227.

External website http://broseberry@cartermackay.com

Contact email address: ramesh.akkarapak@makroscientific.com - 16th Sep 2009 [1793]

Job Title: Senior Biochemist Location: West Point, PA Duration: 1 year

Required Skills: Familiarity with immunoassay (ELISA) and handling/processing of biological fluids (e.g., serum, plasma) obtained from animals and/or human to support PK and TK studies. An MS degree in biochemistry/biology and 2-5 years of industrial experience in bioanalysis using ELISA techniques are required.

Job Responsibilities: Sample packaging and shipment to CROs. Assist sample tube labeling and record keeping. Aliquot serum samples obtained from GLP studies. Pick up samples from different location across the campus. Be able to learn and utilize the analysis of drugs in serum or in buffers using immunoassay methods. Should be able to contribute to report preparations and data processing. Familiarity with GMP guidelines is a plus. Searching for more jobs? Visit at: http://makroscientific.com/makroscientific/Jobs/searchJobs.aspx Contact: Ramesh The best telephone number to reach me is 973-481-0100 Ext: 3059. I appreciate if you forward your updated word formatted resume at ramesh.akkarapak@makroscientific.com for review before we speak. For any reason, you are not able to submit your resume or for any further information, please call our Candidate Help Desk at 973-679-5005.or E-mail your resume at recruiter@makroscientific.com. We shall be happy to help you. *** MAKRO is an INC 5000 company for 2007, 2008 and 2009 *** MAKRO is a 3-time FAST 50 technology firm in NJ for 2005/2006/2007 (awarded by Deloitte) *** MAKRO is a 3-time FAST 500 technology firms in USA for 2005/2006/2007 (awarded by Deloitte)

Contact email address: gemick@comcast.net - 16th Sep 2009 [1791]

Sr. Scientist/Principal Scientist Clinical Pharmacology Jersey City, NJ Summary Clinical Pharmacology and Drug Dynamics

Duties and Responsibilities

Requirements Education: Ph.D. in Pharmacokinetics and Pharmacodynamics Experience: 3-7 years of postdoctoral and industrial experience Knowledge, Skills and Abilities:

Contact email address: gemick@comcast.net - 16th Sep 2009 [1790]

Sr. Principal Scientist – Fellow Clinical Pharmacology and Drug Dynamics Clinical Pharmacology Jersey City, NJ Summary

PhD in Pharmacokinetics and Pharmacodynamics or related field with 12+ years experience in the pharmaceutical industry primarily in clinical pharmacology, and also in the preclinical pharmacokinetics and drug discovery research disciplines. This individual will have responsibility for the pharmacology, pharmacokinetics, pharmacodynamics and safety evaluation of compounds under discovery research, pre-clinical and Phase I development at Forest within the scope of Clinical Pharmacology and Drug Dynamics Department. This person will lead and serve as a consultant for topics such as noon-compartmental PK, population PK-PD, MTD and QT prolongation, to the scientists in Clinical Pharmacology and Drug Dynamics Department across all therapeutic areas of interest.

Duties and Responsibilities Participates in writing package inserts. Provides input and supervision of preclinical pharmacokinetics and toxicokientics, clinical pharmacology and human pharmacokinetics and bioavailability sections of the NDA's, and SNDA's. Reviews in-licensing dossier, evaluates and participates in in-licensing of drug products. Conducts due diligence. Develops Clinical Pharmacology and Pharmacokinetic strategy for in-licensed compounds. Responsible for conducting and reporting all Pharmacokinetics, Pharmacodynamics, ADME and Bioequivalence and bioavailability studies. Reviews in-licensing dossier, evaluates and participates in in-licensing of drug products. Conducts due diligence. Develops Clinical Pharmacology and Pharmacokinetic strategy for in-licensed compounds. Designs study and generates clinical pharmacokinetic, bioavailability and bioequivalence reports. Directs and coordinates activities between clinical sites and Pharmacokinetics department. Analyzes data and prepares reports for IND, NDA, and ANDA submissions. Analyzes data and prepares toxicokinetic reports.

Requirements Education: Ph.D. in Pharmacokinetics and Pharmacodynamics or related field. Experience: 7+ years of relevant technical/managerial experience in Pharmaceutical Industry. Knowledge, Skills, and Abilities * Understanding of the drug development process * Knowledge of GCP/ICH guidelines and FDA regulations * PK/PD software skills (WinNonlin, Kinetica, TopFit, NONMEM, etc.) * Good organizational and interpersonal skills * Ability to communicate effectively verbally and in writing: good presentation skills * Computer and software skills (Word, Excel)

Last update: Sun 14 Mar 2010 09:27:55 am

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