Associate Director, Clinical Operations (Late-Phase)

Location: Hybrid in Thousand Oaks, California or San Francisco, California; candidates should be local to Thousand Oaks or the San Francisco Bay Area. Up to 25% travel may be required.

Company

Biotherapeutics company conducting late-phase clinical development programs.

What you will do

• Lead the execution of assigned Phase 2 and Phase 3 multi-center clinical trials.
• Define and implement trial operational strategies with cross-functional study teams and clinical leadership.
• Develop and manage trial timelines, milestones, risks, communications, and budgets.
• Contribute to clinical documents, including protocols, amendments, investigator brochures, case report forms, informed consent forms, and study plans.
• Select and manage vendors, oversee contractors, perform co-monitoring as needed, and support site and trial oversight.
• Ensure compliance with SOPs, ICH/GCP guidelines, FDA regulations, and clinical data quality standards.

Requirements

• Bachelor’s degree in life sciences.
• At least 8 years of relevant industry experience, including more than 3 years on acute and/or chronic pain studies.
• Experience directing and managing Phase 2 and Phase 3 clinical trials.
• Proficient knowledge of ICH GCP, CFR, and other applicable clinical trial regulations.
• Experience with resource, budget, and vendor management.
• Strong critical thinking, problem-solving, negotiation, communication, collaboration, and prioritization skills.

Culture & Benefits

• Work with cross-functional internal and external stakeholders, including scientific advisors, clinical consultants, CROs, and investigators.
• Fast-paced environment requiring independent work, attention to detail, and delivery against critical deadlines.
• Opportunity to contribute to department SOPs, systems, policies, best practices, and GCP inspection readiness.
• Potential responsibility for direct reports, including performance management, mentorship, and career development.