Medical Director, Autoimmunity

Fate Therapeutics, Inc.; San Diego (CA); On-site; USD 290,000 - 310,000; Full time

Benefits offered by this job

Annual bonus

Equity options

Generous benefits package

Job summary

A leading biopharmaceutical company located in San Diego is seeking a Clinical Development Leader for autoimmune programs. This role requires an M.D. or M.D./Ph.D. degree, along with 4+ years of clinical development experience, helping to guide trials from first-in-human studies through to registrational studies. The candidate will be a key player in protocol development and cross-functional collaboration. A competitive salary package is offered, anticipating a range between $290,000 - $310,000 annually.

Qualifications

• 4+ years of experience in clinical development with trials design and execution.
• Experience managing clinical programs from Phase 1 to 3 is preferred.
• Knowledge of autoimmune diseases such as lupus or rheumatoid arthritis.

Responsibilities

• Lead clinical development plans for autoimmune programs.
• Contribute to study designs and protocol development.
• Engage in Clinical Study Reports preparation and reviews.

Skills

Clinical leadership

Protocol development

Collaboration

Multi-tasking

Presentation skills

Education

M.D. or M.D./Ph.D. degree

Board Certification in medical rheumatology

Job description

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.

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

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About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

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