Associate Director, Clinical Pharmacology, Pharmacometrics

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Vir Biotechnology, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Vir Biotechnology, Inc. is a company focused on leveraging the potential of the immune system to address critical unmet medical needs and improve patient outcomes. It specializes in the discovery, engineering, and development of antibody-based medicines for viral health challenges such as COVID-19 and Ebola. Vir Biotechnology employs innovative platforms like the next-generation antibody and the PRO-XTEN™ protease-releasable masking technologies. With a therapeutic concentration on infectious diseases like hepatitis B and delta, as well as strategic programs in oncology, Vir is committed to advancing medical science and delivering transformative medicines efficiently. The company is supported by an experienced leadership team proficient in progressing product candidates through various stages of research to commercialization.

📋 Description

• 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

🎯 Requirements

• 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)

🏖️ Benefits

• Health insurance • 401(k) matching • Paid time off • Professional development opportunities