Medical Director, Autoimmunity

Responsibilities

• Provide clinical leadership of a comprehensive and integrated Clinical Development Plan for individual autoimmune programs from first-in-human studies through registrational studies.
• Contribute to study designs, lead protocol development, and collaborate with cross-functional teams in study start-up activities in partnership with clinical investigators, key opinion leaders and Health Authorities.
• Direct hands-on involvement in all aspects of study conduct, in collaboration with Fate clinical development and contracted personnel, in the conduct of clinical activities including medical monitoring, data review, analysis, and reporting that conforms to the highest ethical, safety and quality standards and in compliance with Fate, GCP and regulatory standards.
• Remain current on the therapeutic landscape in the relevant therapeutic areas through review of the scientific literature, interactions with key opinion leaders and other external experts and attendance at relevant scientific meetings to provide input and guidance for the strategic direction of Fate programs.
• May participate as clinical contributor in Fate business development and investor-related activities.
• May participate in Health Authority interactions.
• Review available preclinical data that could inform the design of future clinical trials.
• Attend and present at investigator meetings and site initiation visits as applicable.
• Actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, and other periodic clinical reports.
• Collaborating with cross-functional groups formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data.
• May oversee direct reports or contractors.

Qualifications

• M.D., M.D./Ph.D. degree or equivalent.
• Board Certification or Board Eligibility in the field of medical rheumatology preferred.
• 4+ years of experience in clinical development, including the design and execution of clinical trials, preferably within a pharmaceutical, biotech or CRO.
• Experience in managing clinical programs from Phase 1 through Phase 3 is preferred.
• Knowledge of autoimmune diseases such as lupus, systemic sclerosis, vasculitis, rheumatoid arthritis, or other relevant indications.
• Experience or exposure to the development of adoptive cell therapies or biologic therapies is desirable.
• Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable.
• Willingness to engage with investigators, key opinion leaders, and external advisors, as well as effectively give presentations at conferences, advisory meetings, and other public forums.
• Ability to multi-task and willingness to flexibly contribute simultaneously to multiple facets of drug development; willingness to learn new therapeutic areas.
• Willingness to educate and mentor internal and external colleagues and collaborators.

Working Conditions & Physical Requirements

• Travel will be required (up to 30%).
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $290,000 - $310,000.