Principal Scientist, Pharmacokinetics
Job Description

Partial Job Description

1) Review bio-analytical method validation reports from CROs and ensure compliance with compendia and other regulatory requirements

2) Review summary basis of approval, prescribing information and other relevant literature of marketed products to prepare summaries in support of pharmacokinetic (PK) studies

3) Design PK studies for demonstrating bioequivalence (BE) for solid, liquid, topical and specialized dosage forms, including parenterals, ophthalmics, otics, nasal sprays, metered dose inhalers, and transdermal patches

4) Develop, review, and recommend scientifically supported PK study BE protocols for ANDAs (and some NDA products)

5) Establish in-vitro in-vivo correlations

6) Conduct model dependent and model?independent analysis of dissolution or drug release data. Analyze data using statistical tools (SAS, etc.) in order to demonstrate bioequivalence of proposed generics.

7)The incumbent will work closely with Product Development scientists in India, US and Israel in designing pharmacokinetic (PK) studies for pharmaceutical products. The incumbent will act as an advisor in clinical drug development, CRO outsourcing, study monitoring, project management, and ensure study designs and their conduct are in compliance with US regulatory requirements.
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Job Requirements

Qualifications / Skills Required

1) 5 plus years of hands-on experience in independently designing pharmacokinetic studies for ANDAs and/or NDA submissions (preferably oral and topical dosage forms)

2) PharmD or PhD in Pharmaceutical Sciences

3) Expertise in Pharmacokinetics / Bioequivalence or Bio-pharmaceutics or associated area

4) Generic industry experience for filing of ANDAs

5) Well versed with FDA and EMEA guidelines on clinical studies and its conduct

6) Good understanding of statistical methodology required in clinical sciences

7) Demonstrated ability to work independently, manage and prioritize multiple projects, and perform concertedly in a team environment,

8) Experience with an industry standard software for Non-compartmental Analysis and PK/PD modeling

9)Team oriented, well-organized, strong written and verbal communication skills

Company Overview

Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.

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