The Director, Clinical Operations is a key member of the clinical operations team, leading the successful execution of clinical trials and programs. The successful candidate will have experience managing complex, early-stage, and/or pivotal auto-immune trials and oncology trials and a good knowledge of clinical operations, ICH/GCP and regulatory requirements, including those of the FDA. This position contributes to and supports Fate’s research and development efforts to advance next-generation cellular immunotherapies for cancer and auto-immune disorders. This is a full-time exempt position and is located at our corporate headquarters in San Diego, CA.
Responsibilities
- Operational leadership and management of several clinical studies, including direct management of clinical trial management team, and CROs.
- Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a highly dynamic and complex environment in accordance with appropriate quality standards including GCP/ICH requirements and Fate SOPs.
- Lead the identification, evaluation, selection, and oversight of clinical trial sites with the clinical trial management team. Partner effectively with participating study sites to ensure smooth study conduct. Assess expected and reported issues and employ strategic decisions to mitigate risk.
- Support the identification, evaluation, selection, oversight and as applicable, governance of clinical vendors, including Contract Research Organizations and disease specific consortiums/health organizations.
- Implement strategic operational activities to ensure efficient study enrollment and high-quality monitoring activities at participating clinical sites, as driven by Corporate Objectives.
- Liaise with finance/accounting and clinical outsourcing in communicating forecast/accruals, variances, and changes to study assumptions.
- Responsible for implementation and oversight of Trial Master File for inspection readiness.
- Develop study documents and tools including study protocols, consent forms, project plans, budgets, logs, templates, newsletters, and others as needed.
- Provide study status by developing and reporting key performance indicators, key risk indicators, and quality metrics and periodic reporting to senior management. Escalate study and/or program issues/risks in a timely and effective manner.
- Oversee study training to investigators, site staff, and internal staff on select study processes.
- Participate in the preparation and follow-up of internal process audits, vendor, and study site quality audits, as well as regulatory authority inspections.
- Responsible for the development and direct management of team members.
- Support the strategic identification, assessment, and planning for staff and CRO resourcing.
- May develop SOPs and best practices, participate in, or lead initiatives and facilitate their implementation.
Qualifications
- B.S. or advanced degree with minimum 10 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
- Strong leadership and risk management, effective decision making, and problem-solving skills required.
- Strong knowledge of strategic clinical operations. Extensive experience with clinical study conduct from start-up through close-out, with global trial and CRO management experience highly preferred.
- Extensive Auto-immune trial and Oncology trial experience required.
- Cell therapy experience highly preferred. Working knowledge of relevant GCPs and FDA regulations.
- Experience operating in a matrix organization.
- Experience managing clinical operations staff and CROs.
- Ability to work effectively with minimal supervision and multi-task activities to effectively manage deliverables across all trials.
- Strong team orientation, with excellent written and oral communication skills.
Working conditions and physical requirements
- Travel may be required (up to 25%).
- Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
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.
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 $200,000 to $235,000 per year.
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.
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