Associate Director, Clinical Pharmacology and Pharmacometrics (Temporary)

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Its clinical-stage portfolio includes programs for chronic hepatitis delta and multiple PRO-XTEN® dual-masked T-cell engagers across validated targets in solid tumor indications. Vir Biotechnology also has a preclinical portfolio of programs across a range of infectious diseases and oncologic malignancies. 

Vir Biotechnology has exclusive rights to the universal PRO-XTEN® masking platform for oncology and infectious disease. PRO-XTEN® is a trademark of Amunix Pharmaceuticals, Inc., a Sanofi company.

We believe the success of our colleagues drives the success of our mission. We are committed to creating a company where everyone feels supported and encouraged to give their best.

Vir Biotechnology is looking for an Associate Director, Clinical Pharmacology and Pharmacometrics (Temporary Staff) who will support 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. 

• 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
• Supports the 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
• Supports 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

• PhD or PharmD or equivalent with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field
• 6+ years industry experience in Clinical Pharmacology and/or Pharmacometrics
• Ability to communicate complex data and concepts to diverse audiences
• Understanding of the multidisciplinary requirements for drug development and ability to work effectively across functions to enable program advancement
• Experience in PK/PD, PopPK and exposure-response modeling. Proficiency in R and extensive hands-on experience with Monolix or NONMEM required
• Experience working on translational and clinical pharmacology work from FIH dose selection through market authorization
• 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 with 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)