Senior Director, Clinical Pharmacology and Translational PK/PD

Vir Biotechnology•San Francisco, CA

1d•Hybrid

About The Position

Vir Biotechnology 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 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. The company believes the success of its colleagues drives the success of its mission and is committed to creating a company where everyone feels supported and encouraged to give their best. The opportunity is for an experienced Sr. Director of Clinical Pharmacology and Translational PK/PD to lead the technical and operational aspects of the department in support of programs across all stages of preclinical and clinical development. This role will work across Vir Bio's portfolio of infectious disease and oncology programs, providing hands-on leadership while managing and developing a team. The individual will work collaboratively with internal and external cross-functional teams and consultants to support the successful and timely advancement of drug development programs, evaluating and applying best practices and innovative techniques to foster successful execution and outcomes of clinical studies. This role reports to the VP of Translational Development and is located in the San Francisco headquarters with an expectation of at least 3 days per week in office.

Requirements

PhD, PharmD, or MD with relevant training in clinical pharmacology, pharmacokinetics, pharmaceutics, or related field with 13+ years industry experience in Clinical Pharmacology, DMPK and/or related fields
Mastery of nonclinical and clinical pharmacokinetic concepts and methodologies with deep understanding of multidisciplinary drug development requirements
Expertise in PK/PD, PopPK and exposure-response modeling with proficiency in R and extensive hands-on experience with Monolix or NONMEM
Extensive experience leading translational and clinical pharmacology work from FIH dose selection through market authorization
Strong understanding of regulatory requirements and experience contributing to regulatory submissions and engagements
Working knowledge of bioanalytical techniques in support of clinical development of small molecules and biologics
Experience with biologics, including monoclonal antibodies and bispecifics required
Proficiency using standard PK analysis and graphing programs (Phoenix WNL, Graphpad, R, etc.)
Proven ability to manage and develop teams

Nice To Haves

experience in oncology and/or infectious disease indications strongly preferred

Responsibilities

Oversee clinical pharmacology and translational PK/PD operations and deliverables across all stages of development for both infectious disease and oncology programs
Represent clinical pharmacology and translational PK/PD as technical expert on cross-functional project teams and provide strategic input to program advancement
Develop fit-for-purpose clinical pharmacology strategies to enable development and regulatory decisions from pre-IND through market authorization
Select and execute appropriate modeling and simulation approaches (PK/PD, PopPK, exposure-response) to inform dose selection, optimization, and justification for Phase 2 and pivotal trials
Author and provide technical input for regulatory documents and submissions (protocols, IBs, briefing packages, INDs, NDAs/BLAs) and responses to questions
Work collaboratively with cross-functional teams, including clinical research, clinical operations, biomarkers, bioanalytical, biometrics, CMC, research, and regulatory in support of program advancement
Establish and manage collaborations with external vendors and collaborating partners
Generate and manage departmental budget(s) and optimize resource allocation across multiple programs
Manage and develop the Clinical Pharmacology and Translational PK/PD team, including hiring, mentoring, and building departmental capabilities to support organizational needs