THE OPPORTUNITY

Vir Biotechnology is looking for a Director, Clinical Pharmacology and Pharmacometrics (Temporary Staff-Remote) who will lead the design, execution, interpretation and reporting of clinical pharmacology data across all stages of drug development.  In this role you will work collaboratively 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.  Additionally, you will apply quantitative modeling approaches, including PK/PD, Population PK and exposure response analysis to guide recommended doses for Phase 2 and pivotal trials. 

This a longer term contract position.

WHAT YOU'LL DO

• Represents clinical pharmacology and pharmacometrics on cross functional project teams
• Select and execute appropriate modeling and simulation approaches (PK/PD, PopPK, exposure-response) to inform dose selection, optimization, and justification
• Work closely with biometrics on preparation of analysis ready datasets
• Leads development of fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization
• Work collaboratively with cross functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, and regulatory in support of program advancement
• Lead the design and execution of Ph1 clinical pharmacology studies (i.e FIH, relative bioavailability, bioequivalence, hepatic impairment, renal impairment, etc)
• 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

WHO YOU ARE AND WHAT YOU BRING

• PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field
• 8+ years industry experience in Clinical Pharmacology and/or Pharmacometrics
• Ability to communicate complex data and concepts to diverse audiences
• Deep understanding of the multidisciplinary requirements for drug development and ability to work effectively across functions to enable program advancement
• Expertise in PK/PD, PopPK and exposure-response modeling. Proficiency in R and extensive hands-on experience with Monolix or NONMEM required
• Extensive experience leading translational and clinical pharmacology work from FIH dose selection through market authorization
• Ability to lead the design and reporting of various Phase 1 studies and contribute to Phase 2/3 studies with respect to dose selection/justification and sampling strategy
• Experience contributing to clinical pharmacology plans and clinical pharmacology components of regulatory submissions as well as representing clinical pharmacology in regulatory engagements
• Extensive experience with biologics, including monoclonal antibodies, bispecifics.
• Experience leading clinical pharmacology and/or pharmacometrics 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)