Executive Director, Clinical Operations
San Diego, CA
Clinical – Clinical Operations /
Exempt Full-time /
Hybrid
Fate Therapeutics is looking for an Executive Director in Clinical Development Operations to lead the execution of the company's clinical programs. This key contributor will work closely, effectively, and collaboratively with other functional leaders across the organization, as well as external stakeholders such as Clinical Research Organizations and trials sites. The ideal candidate will have experience leading complex, early-stage clinical studies in oncology and/or autoimmunity from strategic planning to study recruitment and completion, and successful closeout. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities
- Drive and lead the successful execution of all operational components of the Company’s clinical programs utilizing strong project management, leadership, and organizational skills; partner with internal and external stakeholders to drive robust data-driven decisions.
- Oversee an efficient, scalable, and sustainable Clinical Development Operations organization that effectively integrates clinical operations with other functional areas to translate the portfolio strategy and objectives from pre-IND through clinical development.
- Accountable for operational execution and strategy across multiple clinical programs, including developing and executing study plans, driving efficient start-up activities and study recruitment, Clinical Research Organization (CRO) management, and trial site management.
- Accountable for assigned portfolio project variable and headcount costs, development and tracking of assumptions related to resource allocation, and oversight of timelines and operational interdependencies for clinical trial execution.
- Lead the development and continuous improvement of SOPs and GCPs relevant to the Clinical Development organization and adherence to established laws, regulations, and guidelines.
- Create synergies with other functional area leaders including Clinical Outsourcing, Program Management, R&D, Manufacturing, Biometrics, Regulatory, QA, Safety Science and Pharmacovigilance, Legal, Finance, and external partners to ensure operational study interfaces are efficiently established and maintained.
- Effectively lead Clinical Operations team members; inspire, influence, and motivate, foster open communication, set clear goals, delegate tasks, and monitor performance.
Qualifications
- BS/BA or advanced degree with a minimum of 14 years of pharmaceutical and/or biotech experience in a clinical drug development setting.
- Strong leadership competencies and influencing skills with senior leaders and cross functional leaders.
- Extensive experience with clinical operations line management, performance management, and staff coaching.
- Proven leadership of clinical operations functions and execution of clinical trials including successful study start-up, site selection, patient recruitment, and relationship building with investigators and CROs; deep knowledge of study site selection and site start up in the oncology or autoimmunity space.
- Experience in clinical resource allocation and budget forecasting.
- Management experience including out-sourcing to third-party organizations, e.g., CROs.
- Expert knowledge of FDA and ICH/GCP regulations and guidelines.
- Experience in the development of protocols, SOPs, clinical study reports, INDs, NDAs and other clinical, regulatory and safety documents required.
- Effective oral and written communication skills to influence, inform and guide the clinical operational team.
- Strong project management skills.
- Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.
- Experience in cell-based therapies is highly preferred.
- Excellent organizational, communication and people management skills required.
Working conditions & physical requirements
- Travel may 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 $275,000 - $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 first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.
