THE OPPORTUNITYVir 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.
WHAT YOU'LL DO- 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
WHO YOU ARE AND WHAT YOU BRING- 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
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WHO WE ARE AND WHAT WE OFFERThe expected salary range for this position is $235,500 to $329,500 per year. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir Biotechnology's compensation and benefits are aligned with the current market and commensurate with the person's experience and qualifications. All full-time employees receive a package that includes compensation, bonus and equity as well as many other Vir Biotechnology benefits and perks such as health and welfare benefit plans, non-accrual paid time off, company shut down for holidays, commuter benefits, 401K match and lunch each day in the office.
Applicants must currently be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
