Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B viruses and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV.
We believe the success of our colleagues drives the success of our mission. We are committed to creating a company passionate about equality, inclusion, and respect. When everyone feels supported and encouraged to give their best, we will collectively deliver outstanding results. We are proud to be the first company to be ranked at the top of the Deloitte Fast 500 list two years in a row (2023 & 2022)!
THE OPPORTUNITY
Vir Biotechnology (Vir), a San Francisco-based company focused on immunology, seeks a Director of Clinical Research. You will report to the Senior Director, Clinical Research – Translational. You will contribute at all stages of development, focusing initially on early-stage development with opportunities to engage from discovery through registration world-wide.
This is an onsite position in our San Francisco, CA office.
WHAT YOU'LL DO
- Work with the clinical team on all scientific aspects of conceptualizing and planning trials.
- Responsible for oversight of ongoing and planned clinical trials including publication planning, investigator meetings and Scientific Advisory Boards.
- Lead clinical evaluations of business development opportunities that would be brought in for future development.
- Work with a senior member of the clinical development team to provide high-level input to complex Phase I-IV clinical trial protocol design, clinical study reports, and Health Authority inquiries.
- Collaborate with the clinical development team to provide ongoing clinical monitoring for clinical trials including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice and Vir Bio SOPs.
- Collaborate with the clinical development team on the clinical research components for the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures, and development plans.
- Coordinate the collection and assimilation of ongoing data for internal analysis and review.
- Manage the preparation and review of data listings, summary tables, study results and scientific presentations.
- Help prepare scientific information for presentation at scientific conferences and clinical study investigator meetings.
- Analyze data for presentation to senior management and regulatory agencies.
- Be a scientific and clinical resource within Vir Clinical Research.
- Provide scientific and clinical guidance to other relevant departments (e.g. research, toxicology, clinical pharmacology, development operations, regulatory, project management).
- Maintain relationships with therapeutic area opinion leaders worldwide to discuss the science and research approaches critical for study protocol design, clinical endpoints and data interpretation.
WHO YOU ARE AND WHAT YOU BRING
- MD (or non-US equivalent of M.D. degree)/PhD or PharmD with six (6) + years' experience required in pharmaceutical industry with experience in clinical research studies and trial design.
- Familiarity with infectious diseases, immunology, or oncology.
- BLA or NDA experience will be valued.
- Experience developing clinical strategies, with global trial and phase 3 experience valued.
- influence in both scientific and interpersonal contexts with all partners.
- Familiarity with good clinical practices and International Conference on Harmonization Guidelines.
- Leadership experience setting vision, leading change, and mentoring others in a flexible matrixed environment.
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WHO WE ARE AND WHAT WE OFFER:
The expected salary range for this position is $194,000.00 to $284,000.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors.
Vir's compensation and benefits are aligned with the current market and commensurate with your experience and qualifications. All full-time employees receive a package that includes: compensation, bonus and equity and many other Vir benefits and perks such as: health, dental, vision, life and disability insurance benefits, non-accrual paid time off, company shut down for holidays, commuter benefits, child care reimbursement, education reimbursement, 401K match and lunch for all onsite employees!
Vir Biotechnology (“Vir”) is an equal opportunity employer. All employment decisions at Vir are based on legitimate, non-discriminatory business requirements, job duties and individual qualifications. Employment decisions are made without regard to race, color, religion, sex (including pregnancy), gender, gender identity, gender expression, sexual orientation, age, parental status, marital status, national origin, ancestry, disability, medical condition, genetic information (including family medical history), political affiliation, military service or any other legally protected characteristic.
This commitment extends to all management practices and decisions, including recruitment and hiring, compensation, appraisal systems, promotions, training and career development programs. Vir also strongly commits to providing employees with a work environment free of unlawful discrimination or harassment.
Vir Human Resources leads recruitment and employment for Vir. Unsolicited resumes sent to Vir from recruiters do not constitute any type of relationship between the recruiter and Vir and do not obligate Vir 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, Inc., participates in E-Verify.
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