THE OPPORTUNITY
Vir Biotechnology is looking for a Medical Director to manage the clinical development of one or more of our oncology drug candidates. More specifically you will manage the entire lifecycle of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication. You will interact with cross-functional teams, including Clinical research, Clinical Operations, Research and Clinical Pharmacology, Regulatory Affairs and others.
The role requires the ability to independently research the area of study, and is a well-organized, strategic focused, resourceful individual with the ability to operate at a “hands on” level.
You will report to the EVP of Therapeutic Oncology.
This role is located in our San Francisco headquarters with an expectation of 4 days per week in office.
WHAT YOU'LL DO
- Contribute to clinical development planning and clinical strategy.
- Provide clinical leadership and medical strategic input for all clinical deliverables of your programs.
- Clinical deliverables may include clinical sections of individual protocols, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
- Represent clinical research in relevant sub-teams.
- Review all key documentation such as IND/CTA, health authority communications and other documents (DUSR, INDAR, DRMP, RMP, etc), protocols and amendments.
- Work collaboratively with regulatory and other functions to deliver the clinical research components in the preparation/review of regulatory documents, IND annual reports, IND safety reports, and investigator brochures.
- Provide ongoing medical and data monitoring for clinical trials including, but not limited to, assessment of eligibility criteria, toxicity management and drug safety surveillance.
- Keep abreast of the highest standards and levels of scientific and clinical knowledge in relevant therapeutic and disease area(s).
- Review all data generated across the program to update strategy and risk assessment.
- Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators.
- Serve as a scientific and clinical resource within Vir, providing scientific and clinical guidance to other relevant functions (e.g., research, toxicology, clinical pharmacology, development operations, regulatory, project management, etc).
WHO YOU ARE AND WHAT YOU BRING
- M.D. degree with 5+ years of relevant industry experience and the completion of a subspecialty fellowship in oncology is highly desirable.
- Experience in Oncology is required.
- Demonstrated ability to independently evaluate, interpret and present complex scientific data.
- Ability to run a clinical research program of complexity with moderate supervision.
- Experienced with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
- Demonstrated ability to work within a multi-disciplinary team of peers and outside experts.
- Solid interpersonal skills, as well as the ability to function in a team environment.
- Ability to adapt and learn quickly in new areas of research, clinical development, and have resourcefulness to independently gather relevant information.
WHO WE ARE AND WHAT WE OFFER
The expected salary range for this position is $194,000 to $284,000. 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 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 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 each day in the office.
#J-18808-Ljbffr