Vir Biotechnology
Senior Director, Clinical Research-Infectious Disease
San Francisco, California, United States · Director · Full-time
No sponsorship$236k-$330kDetected 28 days ago
GCPHRIntellectual PropertyClinical TrialsClinical ResearchFDA RegulatoryResearchAnimal StudiesLeadershipPublic SpeakingBiostatisticsRegulatory Affairs
About the role
- This role is located in our San Francisco headquarters with an expectation of at least 3 days per week in office.
Responsibilities
- Lead one of our HDV Phase 3 studies for Clinical Development and support the Clinical Development Sub team Lead
- 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
- 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.
- We believe the success of our colleagues drives the success of our mission.
Requirements
- MD, or PharmD/PhD and 8-10+ years of clinical development experience in the biopharmaceutical industry, with infectious disease or hepatology experience.
Compensation
- The expected salary range for this position is $235,500 to $329,500 per year.
Benefits
- 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
- 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
- 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.
Company info
- The 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.
- All employment decisions at Vir Biotechnology are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications.
- Employment decisions are made without regard to any legally protected characteristics.
- This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs.
- Vir Biotechnology also strongly commits to providing employees with a work environment free of unlawful conduct or harassment.
- Vir Biotechnology Human Resources leads recruitment and employment for Vir Biotechnology.
- Unsolicited resumes sent to the company from recruiters do not constitute any type of relationship between the recruiter and Vir Biotechnology and do not obligate us to pay fees should we hire from those resumes.
- We ask that external recruiters and/or agencies not contact or present candidates directly to our hiring manager or employees.
- For hires based in the United States, Vir Biotechnology, participates in E-Verify.
- We are committed to creating a company where everyone feels supported and encouraged to give their best.
Visa & Work Authorization
- 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.
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