The Director, Clinical Operations is a key member of the clinical operations team, responsible for leading the successful execution of clinical trials and programs. The ideal candidate will have experience managing complex, early-stage, and/or pivotal trials in autoimmune and oncology indications, along with strong knowledge of clinical operations, ICH/GCP guidelines, and regulatory requirements, including those of the FDA. This full-time exempt position is based in San Diego, CA.
Responsibilities:
- Provide operational leadership and management for multiple clinical studies, including the direct oversight of the clinical trial management team and CROs.
- Ensure clinical trial activities and deliverables are completed on time, within budget, and in compliance with quality standards, including GCP/ICH requirements.
- Lead the identification, evaluation, selection, and oversight of clinical trial sites, ensuring smooth study conduct through effective collaboration with site staff. Anticipate and mitigate risks proactively.
- Oversee the identification, evaluation, selection, and governance of clinical vendors, such as CROs and disease-specific organizations.
- Implement strategic operational initiatives to ensure efficient study enrollment and high-quality monitoring at clinical sites, aligned with corporate objectives.
- Collaborate with finance/accounting and clinical outsourcing teams to communicate forecasts, accruals, variances, and study assumptions.
- Ensure inspection readiness by managing the implementation and oversight of the Trial Master File.
- Develop study-related documents and tools, including protocols, consent forms, project plans, budgets, templates, and other required materials.
- Provide study status updates through key performance indicators, risk indicators, and quality metrics. Report regularly to senior management and escalate issues as necessary.
- Oversee training for investigators, site staff, and internal teams on specific study processes.
- Participate in or support audits, including internal process audits, vendor audits, study site quality audits, and regulatory inspections.
- Lead and manage the development of team members and support resource planning for staff and CROs.
- Contribute to or develop SOPs and best practices and facilitate their implementation.
Qualifications:
- Bachelor’s or advanced degree with a minimum of 10 years of experience managing clinical trials in a biotech, pharmaceutical, or CRO environment.
- Strong leadership, risk management, decision-making, and problem-solving skills.
- In-depth knowledge of strategic clinical operations with extensive experience in conducting clinical studies from start-up through close-out. Global trial and CRO management experience highly preferred.
- Extensive experience with autoimmune and oncology trials is required.
- Experience with cell therapy is highly preferred, along with knowledge of GCPs and FDA regulations.
- Proven experience in a matrix organization and managing clinical operations staff and CROs.
- Ability to work independently, prioritize multiple tasks, and manage trial deliverables effectively.
- Strong team player with excellent written and verbal communication skills.
