Clinical Operations Director

7 days ago

California, United States Meet Full time
Director Clinical Operations Job Description

Meet is seeking a highly experienced Director Clinical Operations to lead the successful execution of clinical trials and programs. As a key member of the clinical operations team, you will be responsible for providing operational leadership and management for multiple clinical studies, including the direct oversight of the clinical trial management team and CROs.

Key Responsibilities:

  • Provide strategic operational leadership and management for multiple clinical studies, ensuring timely completion, within budget, and in compliance with quality standards.
  • Lead the identification, evaluation, selection, and oversight of clinical trial sites, ensuring smooth study conduct through effective collaboration with site staff.
  • 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.

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