DIRECTOR, CLINICAL RESEARCH INFECTIOUS DISEASE
Vir integrates diverse innovations in science, technology, and medicine to transform the care of people with serious infectious diseases. Vir is taking a multi-program, multi-platform approach to applying these breakthroughs, including the development of treatments that induce protective and therapeutic immune responses. Vir’s scale and scope together with leading scientific and management expertise, allow it to perform significant internal R&D, in license or acquire innovative technology platforms and assets, and fund targeted academic research.
Vir Biotechnology (Vir), a San Francisco based company focused on infectious disease, seeks a Director of Clinical Research, Infectious Disease. Reporting to the VP for Clinical Development, the Director of Clinical Research, Infectious Disease, is a crucial position at Vir. You will play a key role at all stages of development, focusing initially on late stage development for all infectious disease programs from the drug discovery stage through product registrations world-wide.
- Will work collaboratively with the clinical team on all scientific aspects of conceptualizing and planning trials.
- Responsible for various aspects and oversight for ongoing and planned clinical trials including but not limited to abstract submission, investigator meetings and Scientific Advisory Boards.
- May serve as a resource to other functions in evaluating business development opportunities.
- Will work with a senior member of the clinical development team to provide high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.
- Will work collaboratively with the clinical development team to provide ongoing clinical monitoring for clinical trials including, but not limited to, assessment of eligibility criteria, toxicity management and drug safety surveillance.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as VirBio SOPs.
- Will work collaboratively with the clinical development ton the clinical research components in the preparation/review of regulatory documents, IND annual reports, IND safety reports, Investigator Brochures and development plans.
- Coordinates the collection and assimilation of ongoing data for internal analysis and review.
- Coordinates and manages the preparation and/or review of data listings, summary tables, study results and scientific presentations.
- Helps to prepare scientific information for presentation at scientific conferences as well as clinical study investigator meetings.
- Analyze and summarize data for presentation to senior management and regulatory agencies.
- Provide assistance and support in managing relationships with regulatory affairs, biostatistics, and other non-clinical departments. Provide strategic guidance on non-regulatory clinical trial plans.
QUALIFICATIONS AND EXPERIENCE:
- 10+ years of relevant experience in industry and preferably with ID specialization or relevant work.
- The successful candidate will have the knowledge, experience, and skills typically developed by a strong track record of accomplishment in the field of clinical research. BLA or NDA experience will be highly valued.
- Excellent scientific written and oral communication skills as well as interpersonal skills are required. Must possess a proven ability to work highly effectively with multiple departments.
- Must be capable of working with attention to detail in a time sensitive environment.
- Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred.
- The candidate we seek is expected to maintain a professional relationship with therapeutic area opinion leaders worldwide, and is equally comfortable discussing the science and research approaches that are critical for study protocol design, clinical endpoints and data interpretation.
- Innate flexibility to work in a rapidly growing matrixed environment. Strong leadership skills with an ability to set a vision, lead change, and mentor others.
- Strategic thinker with ability to formulate, develop and execute clinical strategies.
- Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict and drive consensus among individuals from a variety of cultures and disciplines.
- MD preferred, however PharmD with extensive late phase experience will be considered.