Senior Director, Clinical Development-Infectious Disease
Vir Biotechnology, Inc.
14 hours ago
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
Senior Director, Clinical Development – Infectious Disease (Hepatitis Delta)
Responsibilities:
- Lead one HDV Phase 3 study and support the Clinical Development Sub team Lead.
- Execute late-stage clinical development plan with oversight of Phase III studies, including medical monitoring and benefit–risk assessment.
- Lead BLA-enabling activities and clinical components of global regulatory submissions (BLA, NDA, MAA) and Health Authority interactions.
- Contribute to life cycle management strategy, including potential post-marketing commitments from a clinical development perspective.
- Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure regulatory-ready datasets, narratives, and summaries meeting FDA/EMA/ICH standards.
- Contribute to key clinical/regulatory documents (protocols, IBs, IND submissions/reports, clinical study reports, development plans).
- Partner with Regulatory Affairs, Biostatistics, Clinical Operations, Safety, Translational Medicine, and Commercial to develop integrated development and registration strategies.
- Interpret and integrate clinical data across studies; drive internal decision documents, integrated analyses, and external publications/presentations.
- Build and maintain relationships with investigators, KOLs, and advisory boards.
- Ensure adherence to GCP/ICH and SOPs and contribute to continuous improvement.
Qualifications:
- MD or PharmD/PhD; 8–10+ years clinical development experience in biopharma with infectious disease or hepatology experience.
- Late-stage/registrational experience; leadership of or major contribution to Phase III programs.
- Direct experience supporting at least one BLA (or NDA/MAA) submission in a clinical leadership role (required).
- Deep familiarity with GCP/ICH and global regulatory expectations.
- Ability to design/interpret complex Phase II/III trials and integrated clinical packages.
- Proven experience leading cross-functional teams.
Benefits (stated): Expected salary range $235,500–$329,500/year; compensation/bonus/equity and benefits including health & welfare plans, non-accrual paid time off, holiday shutdown, commuter benefits, 401K match, and lunch in the office.
Application instructions:
- Applicants must be authorized to work in the U.S.; company cannot sponsor or take over visa sponsorship at this time.
Responsibilities:
- Lead one HDV Phase 3 study and support the Clinical Development Sub team Lead.
- Execute late-stage clinical development plan with oversight of Phase III studies, including medical monitoring and benefit–risk assessment.
- Lead BLA-enabling activities and clinical components of global regulatory submissions (BLA, NDA, MAA) and Health Authority interactions.
- Contribute to life cycle management strategy, including potential post-marketing commitments from a clinical development perspective.
- Partner with Regulatory Affairs, Biostatistics, Data Management, and Medical Writing to ensure regulatory-ready datasets, narratives, and summaries meeting FDA/EMA/ICH standards.
- Contribute to key clinical/regulatory documents (protocols, IBs, IND submissions/reports, clinical study reports, development plans).
- Partner with Regulatory Affairs, Biostatistics, Clinical Operations, Safety, Translational Medicine, and Commercial to develop integrated development and registration strategies.
- Interpret and integrate clinical data across studies; drive internal decision documents, integrated analyses, and external publications/presentations.
- Build and maintain relationships with investigators, KOLs, and advisory boards.
- Ensure adherence to GCP/ICH and SOPs and contribute to continuous improvement.
Qualifications:
- MD or PharmD/PhD; 8–10+ years clinical development experience in biopharma with infectious disease or hepatology experience.
- Late-stage/registrational experience; leadership of or major contribution to Phase III programs.
- Direct experience supporting at least one BLA (or NDA/MAA) submission in a clinical leadership role (required).
- Deep familiarity with GCP/ICH and global regulatory expectations.
- Ability to design/interpret complex Phase II/III trials and integrated clinical packages.
- Proven experience leading cross-functional teams.
Benefits (stated): Expected salary range $235,500–$329,500/year; compensation/bonus/equity and benefits including health & welfare plans, non-accrual paid time off, holiday shutdown, commuter benefits, 401K match, and lunch in the office.
Application instructions:
- Applicants must be authorized to work in the U.S.; company cannot sponsor or take over visa sponsorship at this time.