Medical Director, Clinical Development

Location
San Diego, CA
Posted
Nov 19, 2021
Ref
554RE
Hotbed
Biotech Beach
Required Education
Doctorate/PHD/MD
Position Type
Full time

Description:

Fate Therapeutics is seeking a highly motivated hands-on physician leader to serve as a medical director in Fates Clinical Development Group. The medical director will support Fates cellular immuno-oncology program(s) in the disease area of B cell malignancies. This individual will develop and implement clinical strategies and be responsible for the oversight of contracted personnel and/or organizations to advance Fates clinical program(s). He or she will also serve as a liaison between Fate and clinical investigators and will maintain established and productive relationships with key opinion leaders, as well as Health Authority representatives. The ideal candidate should have experience in hematologic malignancies, with experience in the design and conduct of clinical studies in this therapeutic area. Experience with cellular therapies is desirable. This is a full-time position reporting to a VP, Clinical Development, and is based at the Companys corporate headquarters in San Diego, California or at our location in the San Francisco Bay area.

Responsibilities:

  • Provide clinical leadership of a comprehensive and integrated Clinical Development Plan for individual immuno-oncology programs from first-in-human studies through registrational studies.
  • Formulate study designs, lead protocol development and collaborate with cross-functional teams in study start-up activities in collaboration with clinical investigators, key opinion leaders and Health Authorities.
  • Have 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 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, in order to provide input and guidance for the strategic direction of Fate programs.
  • Participate as clinical contributor in Fate business development and investor-related activities.
  • Play a key role 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.
  • In collaboration with appropriate cross-functional team members 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

Qualifications:

  • M.D., M.D./Ph.D. degree or equivalent.
  • Board Certification or Board Eligibility in the field of Hematology and/or Medical Oncology highly desirable.
  • 5+ years of experience in clinical research including the design and execution of clinical trials, preferably within a pharmaceutical or biotech environment.
  • Experience or exposure to the development of adoptive cell therapies or biologic therapies is desirable.
  • Experience in novel and innovative designs for early Phase studies; Phase 3 trial experience is a plus.
  • Experience with U.S. and European Health Authority interactions and submission of clinical regulatory documents is desirable.
  • Strong written and verbal communication skills; willingness to engage with investigators, key opinion leaders and external advisors; and ability to effectively give presentations at conferences, advisory meetings and other public forums.
  • Engaged, hands-on, independent and goal-oriented mentality; willingness to work in highly dynamic work environment and embrace uncertainty.
  • Ability to multi-task and willingness to flexibly contribute simultaneously in multiple facets of drug development; willingness to learn new therapeutic areas.
  • Self-motivation; good judgment; strong commitment to follow up on tasks and action items; organizational, analytical, and problem-solving skills; risk identification and management; creative and innovative thinking all highly desirable.
  • Strong leadership skills with ability to work within and lead and motivate a cross-functional matrixed team.
  • Willingness to educate and mentor internal and external colleagues and collaborators.
  • Ability and willingness to travel as required.

Working Conditions and Physical Requirements:

  • May require occasional evening and weekend work.
  • Full-time onsite work at Companys headquarters in San Diego or in South San Francisco office.
  • Minimum 10% time traveling to clinical sites and clinical/professional meetings. May include international travel.

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.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first- in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company’s immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.