Director / Associate Director, Clinical Operations (Multiple Myeloma Franchise)

Location
San Diego, CA, United States
Posted
Sep 07, 2020
Ref
347SW
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate's Clinical Operations team is currently seeking a hands-on talented and motivated clinical operations professional to lead our hematology clinical program. The successful candidate must have extensive experience managing early and late-stage clinical trials, experience managing direct reports, and a good knowledge of clinical operations, GCP and FDA regulatory environment. The position provides leadership and guidance to clinical operations staff and establishes and maintains relationships with CROs and vendors supporting clinical operations deliverables. This position collaborates cross-functionally with clinical development, clinical operations, regulatory affairs, and quality assurance teams. Extensive oncology trial experience preferred. This is a full-time position reporting to the Executive Director, Clinical Operations, and is located at our Company's headquarters in San Diego, California.

Responsibilities:
• Responsible for leading strategic initiatives supporting Fate Clinical Operations and hematology clinical trials.
• Manage direct reports and contribute to training and mentoring of CTMs, associate CTMs and CTAs.
• Lead process development in support of the clinical operations department.
• Oversee study subject enrollment and strategy for participating clinical sites.
• Develop study documents and tools including study protocols, consent forms,
project plans, budgets, logs, templates, newsletters, and other, as needed.
• Develop SOPs and best practices and facilitate their implementation.
• Provide study status updates and reports to the executive leadership team.
• Oversee strategic relationships with vendors and key clinical investigators.
• Develop and deliver study training to investigators, site staff, and internal staff on
select study processes.
• Develop processes and provide oversight of study supplies management.
• Conduct external meetings (e.g., Investigator Meetings), conferences and events.
• Interface with representatives from other internal key functional groups including
research and development, regulatory, quality, and legal as appropriate.

Qualifications
• B.S. degree with minimum 8 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment
• Extensive experience leading teams
• Oncology experience required (solid tumor, lymphoma or multiple myeloma
experience highly preferred)
• Sponsor experience required
• Immunotherapy or cellular therapy experience highly preferred
• Excellent knowledge of clinical operations and experience with clinical study conduct from start-up through close-out
• Experience or exposure to the development of cell therapies a plus
• Working knowledge of ICH GCP and FDA regulations
• Ability to work, lead and motivate a cross-functional matrix team
• Excellent negotiation and conflict management skills; ability to influence change and
process improvements internally and at clinical sites and CROs
• Strong team orientation, with excellent written and oral communication skills

Working Conditions and Physical Requirements
• May require occasional evening and weekend work
• Full-time onsite work at Company's headquarters in San Diego
• Minimum 10% time traveling to clinical sites and clinical/professional meetings
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. For consideration send cover letter and curriculum vitae to: careers@fatetherapeutics.com and reference job 347SW.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. 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 product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.