Clinical Research Director jobs in San Francisco, CA

Vir Biotechnology (Vir), a San Francisco based company focused on infectious diseases and immunology, seeks a Director of Clinical Research.  Reporting to the VP for Clinical Development, you will play a key role at all stages of development, focusing initially on early stage development with opportunities to engage from discovery through registration world-wide.

Preference given to candidates willing to work onsite in our San Francisco, CA office. We will consider remote employees. Vir only supports candidates within the United States and reserves the right to approve work locations.

RESPONSIBILITIES AND LEARNING OPPORTUNITIES:

• Work collaboratively 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 VirBio 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 and summarize data for presentation to senior management and regulatory agencies.
• Serve as a scientific and clinical resource within Vir Clinical Research
• Provide scientific and clinical guidance to other relevant functions (eg, research, toxicology, clinical pharmacology, development operations, regulatory, project management, etc)
• 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.

QUALIFICATIONS AND EXPERIENCE:

• 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, and/or oncology preferred.
• BLA or NDA experience will be highly valued.
• Experience formulating, developing, and executing clinical strategies, with global trial and phase 3 experience highly valued.
• Ability to communicate and influence in both scientific and interpersonal contexts with internal and external stakeholders.
• Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred.
• Leadership experience setting vision, leading change, and mentoring others in a flexible matrixed environment.