Associate Director, Clinical Operations (Late-Phase)

Position Summary

Reporting to the Senior Director, Clinical Operations, the Associate Director will be responsible for leading the execution of assigned late-phase clinical trials. This individual will work directly with the cross-functional study team to define and implement the operational strategy for assigned trials, and deliver on milestones within prescribed timelines and budget, and with high quality. The ideal candidate will be experienced in leading Phase 2 and Phase 3 multi-center trials, possess strong verbal and written communication skills, and be able to work effectively and independently in a fast-paced environment.

Candidates should be local to Thousand Oaks, CA or the San Francisco Bay area.

Responsibilities Include (but Are Not Limited To)

• Define and implement the operational strategy for assigned clinical trials, in collaboration with the cross-functional team and clinical leadership.
• Provide expertise into the development of clinical documents (eg., study protocols and amendments, investigator brochures, case report forms, informed consent forms, study plans, site manuals, etc.). Author portions of clinical documents as required.
• Develop and manage trial timelines to ensure alignment with overall program objectives and milestones.
• Effectively manage trial communication to ensure stakeholders are informed of and aligned on trial activities and progress.
• Proactively identify, communicate, and manage risks that may affect trial milestones, quality, or budget.
• Identify and select qualified vendors. Responsible for vendor performance management.
• Perform co-monitoring, as required, to support site, vendor and trial oversight.
• Ensure clinical studies are conducted in compliance with SOPs, ICH/GCP guidelines, and FDA regulations. Oversee and ensure high quality of clinical trial execution and trial data.
• Oversee and direct clinical contractors, as required.
• Oversee and ensure accuracy of clinical trial budgets. Oversee accruals reporting and forecasting for assigned trials. Review vendor invoices for accuracy.
• Contribute to Clinical Operations resource and budget planning.
• Contribute to the development of department SOPs, systems, policies, best practices, and standards that support high quality clinical trial execution and GCP inspection readiness.
• May manage direct reports, including ongoing performance management, mentorship, and career development.
• Up to 25% travel may be required, consistent with project needs.
  
  

Minimum Requirements

• Bachelor’s Degree in life sciences
• 8 years relevant industry experience
• Proficient knowledge of ICH GCP, CFR, and other applicable regulatory requirements for clinical trial conduct.
• Prior experience directing and managing Phase 2 and Phase 3 clinical trials. Prior experience with pain or analgesia trials preferred but not required.
• Prior experience with resource, budget, and vendor management.
• Demonstrated critical thinking, problem solving, and negotiation skills
• Demonstrated ability to successfully work in cross-functional project teams with an emphasis on teamwork, collaboration, and communication.
• Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders (e.g., scientific advisors, clinical consultants, CROs, investigators).
• Self-disciplined, detail-oriented, and able to prioritize tasks to meet critical deadlines.