Fate Therapeutics
Director, Clinical Operations
Fate Therapeutics, San Diego, California, United States, 92189
San Diego, CA
Clinical – Clinical Operations /
Exempt Full-time /
On-site
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.
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Clinical – Clinical Operations /
Exempt Full-time /
On-site
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.
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