THE OPPORTUNITY
Vir Biotechnology is looking for a Pharmacometrician to lead our pharmacometrics strategy across therapeutic areas and programs, from early clinical development to market application and commercialization. The Director, Pharmacometrics will join the Clinical Pharmacology department and report to the VP of Clinical Pharmacology.
This is an onsite position in our San Francisco headquarters.
WHAT YOU'LL DO
- Working in collaboration with the Project Lead Clinical Pharmacologist you will develop and implement model informed drug development (MIDD) plans across projects and disease areas to optimize prospective studies and inform drug development strategy and project decision-making.
- With the Project Lead Clinical Pharmacologist you will be responsible for pharmacometrics activities including population pharmacokinetics modeling and simulations, PK/PD and exposure-response.
- Conduct modeling and simulations activities for programs across multiple stages of development, from pre-IND through post-marketing.
- Present modeling and simulation data as a technical pharmacometrics expert on cross-functional project sub-teams.
- Identify opportunities where modeling and simulation can promote the understanding of pharmacological activity, efficacy and safety.
- Provide support and help develop our quantitative methodology, pharmacometrics tools, software, hardware, and related business processes.
WHO YOU ARE AND WHAT YOU BRING
- PhD with at least 10 years of experience OR MS degree with at least 13 years of experience
- Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics or biostatistics.
- Experience with quantitative modeling including performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, R, Monolix, Phoenix) for protein therapeutics (e.g. mAbs, siRNA) and small molecule therapeutics.
- Experience managing MIDD (model informed drug development) regulatory strategies together with clinical pharmacology project leads to achieve desired outcomes.
- Experience with quantitative systems pharmacology (QSP) and physiologically based pharmacokinetic (PBPK) modeling.
- Experience with clinical pharmacology studies to support intrinsic/extrinsic factors and the ability to author and defend pharmacometrics components of regulatory filings.
- Lead modeling and simulations activities with external CROs.
- Mentor junior staff within Clinical Pharmacology.
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $194,500 to $284,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity as well as many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite employees!
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