Executive/Senior Director, Clinical Operations

Fate Therapeutics is looking for an Executive or Senior Director in Clinical Operations to drive the efficient and compliant delivery 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, completion, and successful closeout. This is a full-time exempt position reporting to the Senior Vice President, Clinical Operations and is located at our corporate headquarters in San Diego, CA 

Responsibilities

• Drive and lead the successful execution of assigned operational components of the Company’s clinical programs utilizing strong project management, leadership, and organizational skills.
• Partners with internal and external stakeholders to drive robust data-driven decisions.
• Ensure the clinical operations organization effectively integrates 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, study recruitment, Clinical Research Organization (CRO) management, and trial site management.
• Identify potential risks to clinical programs and develop and implement mitigation strategies to address them proactively.
• 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 Operations 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.
• Mentor and lead a high-performing clinical operations team, fostering a culture of collaboration, accountability, and continuous improvement.

Qualifications

• Bachelor’s degree with a minimum o f14years in clinical research in the pharmaceutical or biotechnology industry. Advanced degree and relevant certifications preferred.
• Strong leadership competencies and influencing skills with senior leaders and cross functional leaders.
• Proven track record of building and leading high-performing teams, with strong interpersonal and communication skills.
• Strong analytical and decision-making skills, with the ability to navigate complex challenges and implement effective solutions.
• 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 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.
• Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.
• Experience in cell-based therapies is highly preferred.

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 $250,000 - $295,000.

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 OpportunityFate 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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