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Position:
Director
Employer:
Vir Biotechnology, Director - Pharmacometrics
Description:
Vir Biotechnology is seeking a Pharmacometrician responsible for leading the pharmacometrics strategy across therapeutic areas and programs, from early clinical development to market application and commercialization.
- The candidate will join the Clinical Pharmacology department reporting to the VP of Clinical Pharmacology.
- Develops and implements model informed drug development (MIDD) plans across projects and disease areas in order to optimize prospective studies, inform drug development strategy and project decision-making, in collaboration with Project Lead Clinical Pharmacologist.
- Responsible for pharmacometrics activities (population pharmacokinetics modeling and simulations, PK/PD, exposure-response, etc) working in close collaboration with the Project Lead Clinical Pharmacologist.
- Conduct modeling and simulations activities for programs across various stages of development (pre-IND through post-marketing).
- Present modeling and simulation data, acting as a technical pharmacometrics expert on cross-functional project sub-team.
- Identifies opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety.
- Help in providing support and/or development of quantitative methodology, pharmacometrics tools, software, hardware, and related business processes.
Qualifications/Experience:
- Ph.D. or equivalent degree with at least 10 years of experience OR MS or equivalent degree with at least 13 years of experience.
- Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics.
- Understanding and ability to guide quantitative/modeling efforts. Experience in performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, R, Monolix, Phoenix, etc.) for protein therapeutics (mAbs, siRNA, etc) and small molecule therapeutics.
- Ability to influence MIDD (model informed drug development) regulatory strategies in conjunction with the clinical pharmacology project lead.
- Strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author and defend pharmacometrics components of regulatory filings.
- Interact with and/or lead modeling/simulations activities with external CROs.
- Mentor and coach junior staff within Clinical Pharmacology.
Location:
REMOTE
Contact:
https://boards.greenhouse.io/virbiotechnologyinc/jobs/4090268005
Post Date:
9/23/2022 12:00:00 AM
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