Clinical Pharmacologist

Overview

Join our client’s team where you will lead the design, execution, interpretation and reporting of clinical pharmacology data across all stages of drug development. Work in a collaborative environment with internal and external cross-functional teams to support the successful and timely advancement of drug development programs. You will present clinical pharmacology data and strategy to internal teams, acting as a technical expert on cross-functional project teams and sub-teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory in support of program advancement. This is a Contract 6 month role based in our San Francisco California office with expectations to be onsite 3 days a week. Responsibilities

Lead the design and execution of Phase 1 clinical pharmacology studies (e.g., FIH, relative bioavailability, bioequivalence, hepatic impairment, renal impairment, etc.). Represent clinical pharmacology on cross-functional project teams and subteams. Lead development of fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization. Provide expertise in dose selection, optimization, and justification, working with PMX to leverage modeling and simulation approaches (PK/PD, PopPK, exposure–response). Author and provide technical input for regulatory documents and submissions (protocols, IBs, briefing packages) and RTQs. May provide guidance to junior clinical pharmacologists in analysis and reporting of study-level clinical pharmacology data and drafting of clinical pharmacology sections of protocols, CSRs, IBs. Qualifications

If YOU ARE A

PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field with 10+ years industry experience in clinical pharmacology and a deep understanding of the multidisciplinary requirements for drug development,

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ability to design and facilitate operation and reporting of various Phase 1 studies and contribute to Phase 2/3 studies with respect to dose selection/justification and sampling strategy,

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extensive experience with biologics, including monoclonal antibodies, bispecifics; experience leading clinical pharmacology strategy for oncology and/or immunology indications preferred. Familiarity with clinical pharmacology strategies for immune modulating agents. Proficiency using standard PK analysis and graphing programs (Phoenix WNL, Graphpad, R, etc). Experience contributing to clinical pharmacology plans and clinical pharmacology components of regulatory submissions as well as representing clinical pharmacology in regulatory engagements.

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to join a company that values innovation, teamwork, and pharmaceutical excellence! —

Please note that candidates for this position must be legally authorized to work in the US without sponsorship to be considered for employment.

All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law. Details

Seniority level : Director Employment type : Contract Job function : Manufacturing and Research Industries : Pharmaceutical Manufacturing Referrals increase your chances of interviewing at PeopleSolutions, Inc. by 2x

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