Senior Director, Head of Clinical Pharmacology

Vir Biotechnology•San Francisco, CA

22h•$235,500 - $329,500•Hybrid

About The Position

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. THE OPPORTUNITY Vir Biotechnology is looking for an experienced Sr. Director of Clinical Pharmacology to lead the technical and operational aspects of the department in support of programs across all stages of preclinical and clinical development. You will work across Vir Bio's portfolio of infectious disease and oncology programs, providing hands-on leadership while managing and developing a team. In this role, you will work collaboratively with internal and external cross-functional teams and consultants to support the successful and timely advancement of drug development programs. You will evaluate and apply best practices and innovative techniques to foster successful execution and outcomes of clinical studies. You will report to the VP of Translational Development. This role is located in our 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
Extensive experience leading translational and clinical pharmacology work from candidate 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
Proven ability to manage and develop teams

Nice To Haves

experience in oncology 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 across all phases of drug development
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