Senior Director, Clinical Development-Infectious Disease

Vir Biotechnology•San Francisco, CA

1d•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 a Senior Director, Clinical Development-Infectious Disease to facilitate late‑stage clinical development for our hepatitis delta (HDV) portfolio, with a primary focus on activities supporting the Phase III clinical program and health authority submission activities. Reporting to the VP, Clinical Development, this senior leader will serve as the key clinical voice in shaping and executing the clinical development strategy You will concentrate on advancing our HDV assets through global Phase III,BLA‑enabling activities and support on relevant commercial activities. This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.

Requirements

MD, or PharmD/PhD and 8-10+ years of clinical development experience in the biopharmaceutical industry, with infectious disease or hepatology experience. Other therapeutic areas experience(s) may be considered with strong regulatory submission experience.
Demonstrated late‑stage/registrational experience, including leadership of or major contribution to Phase III programs, and direct experience supporting at least one BLA (or NDA/MAA) submission in a clinical leadership role required
Deep familiarity with GCP, ICH guidelines, and global regulatory expectations for registrational trials
Proven ability to design and interpret complex Phase II/III clinical trials and integrated clinical packages, and to interact effectively with Health Authorities, KOLs, and internal senior leadership.
Demonstrated experience leading cross‑functional teams

Responsibilities

Lead one of our HDV Phase 3 studies for Clinical Development and support the Clinical Development Sub team Lead
Execute the late‑stage clinical development plan providing oversight of Phase III studies, incl, including medical monitoring and benefit–risk assessment
Lead BLA‑enabling activities and clinical components of global regulatory submissions (e.g., BLA, NDA, MAA) and Health Authority interactions
Contribute to the development and execution of a life cycle management strategy, including but not limited to potential post marketing commitments from a clinical development perspective
Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure clinical datasets, narratives, and summaries meet FDA, EMA, and ICH standards for regulatory filings
Contribute to key clinical and regulatory documents, including protocols, IBs, IND submissions and reports, clinical study reports, and development plans
Partner with Regulatory Affairs, Biostatistics, Clinical Operations, Safety, Translational Medicine, and Commercial to develop and execute integrated development and registration strategies
Interpret and integrate clinical data across studies and drive preparation of internal decision documents, integrated analyses, and external publications/presentations
Build and maintain strong relationships with investigators, KOLs, and advisory boards in infectious diseases
Ensure adherence to GCP, ICH guidelines, and SOPs, and contribute to continuous improvement of clinical development processes