Associate Director, Clinical Pharmacology and Pharmacometrics
V
Vir Biotechnology, Inc.Biopharmaceutical
Remote - United StatesContractSenior
Salary95 - 118 USD per hour
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Job Details
- Experience
- 6+ years
- Required Skills
- R
Requirements
- PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or a related field.
- 6+ years of industry experience in clinical pharmacology and/or pharmacometrics.
- Extensive experience with biologics, including monoclonal antibodies and bispecifics.
- Proficiency in R and extensive hands-on experience with Monolix or NONMEM.
- Proficiency using standard PK analysis and graphing programs such as Phoenix WNL and Graphpad.
- Experience working on translational and clinical pharmacology from FIH dose selection through market authorization.
- Experience contributing to clinical pharmacology plans and regulatory submissions.
- Experience representing clinical pharmacology in regulatory engagements.
- Ability to communicate complex data and concepts to diverse audiences.
- Understanding of multidisciplinary requirements for drug development.
Responsibilities
- Represent clinical pharmacology and pharmacometrics on cross-functional project teams.
- Select and execute modeling and simulation approaches (PK/PD, PopPK, exposure-response) to inform dose selection, optimization, and justification.
- Collaborate with biometrics on the preparation of analysis-ready datasets.
- Develop fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization.
- Work collaboratively with clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory teams.
- Support the design and execution of Phase 1 clinical pharmacology studies (e.g., FIH, relative bioavailability, bioequivalence, hepatic and renal impairment).
- Author and provide technical input for regulatory documents and submissions, including protocols, IBs, briefing packages, and RTQs.
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