Primary RoleThe Associate Director, Clinical Operations provides line management and functional oversight for a team of clinical trial staff spanning Clinical Trial Associate (CTA), Clinical Research Associate (CRA), Clinical Trial Manager (CTM), and Clinical Project Manager (CPM) levels. Trials are run in-house rather than outsourced to a CRO, so this role and its team hold direct, hands-on responsibility for site management, monitoring, and trial execution rather than oversight of a CRO's delivery. This role is responsible for staff development, workload/resource allocation across assigned studies or programs, and ensuring consistent quality and process adherence across the team, while individual contributors retain day-to-day accountability for their assigned trials.
What you'll doPeople Management- Directly manage, coach, and develop a team of 6-12 clinical staff across CTA, CRA, CTM, and CPM levels
- Conduct performance reviews, goal setting, and career development planning tailored to each direct report's role and level
- Lead recruitment, onboarding, and training for new team members
- Identify training needs and coordinate role-specific development (e.g., TMF management for CTAs, site monitoring for CRAs, vendor oversight for CTMs, cross-functional leadership for CPMs)
Resource & Workload Management- Allocate staff across studies based on trial phase, complexity, and enrollment status
- Monitor team capacity and escalate resourcing gaps or overallocation to the Director/Senior Director
- Support study budgeting and FTE planning in partnership with Clinical Operations leadership
Operational & Quality Oversight- Ensure team members follow ICH-GCP, SOPs, and applicable regulatory requirements across assigned trials
- Review and approve key study deliverables (monitoring plans, TMF completeness, site management plans) as appropriate to level
- Provide direct, hands-on guidance on site selection, initiation, monitoring, and close-out - activities performed in-house by the team's CRAs and CTMs rather than a CRO
- Serve as an escalation point for site-level or protocol-execution issues that direct reports cannot resolve independently
- Partner with QA on audit/inspection readiness and CAPA follow-up for the team's studies
Cross-Functional Collaboration- Represent Clinical Operations staffing and capacity needs in program-level planning meetings
- Partner with Clinical Development, Regulatory, Biostatistics, and Data Management leads to align trial execution with program timelines
- Provide input to senior leadership on process improvements and standardization across trials
LocationMountain View, CA or Remote (US)
Salary Range$170,000 - $185,000
*depending on qualifications and experience levelTravel RequiredTravel required (approximately 25-30%)
QualificationsRequired Skills/Abilities: - 10+ years of hands-on clinical trial experience across multiple Clinical Operations roles, including CTA, CRA, CTM, and/or CPM experience.
- 3+ years of direct people management experience.
- Direct experience with site monitoring, site management, and clinical trial execution in an in-house operating model.
- Strong working knowledge of ICH-GCP, FDA/EMA regulations, and the clinical trial lifecycle.
- Demonstrated experience managing and developing Clinical Operations staff across varying levels of seniority.
- Strong organizational, communication, and problem-solving skills, with the ability to manage competing priorities across multiple studies.
- Experience with inspection readiness, audits, and CAPA follow-up.
- Experience supporting multiple clinical programs or studies simultaneously.
Bonus Skills/Abilities: - Experience building or improving Clinical Operations processes, tools, and ways of working in a growing biotech environment.
Supervisory Responsibilities:
- Directly manages, coaches, and develops Clinical Operations staff across CTA, CRA, CTM, and CPM levels, including performance management, goal setting, career development, and workload allocation.
Education and Experience:- Bachelor's degree in life sciences, nursing, or related field (advanced degree a plus)
Physical Requirements: - Required to sit for prolonged periods of time.
- Ability to travel domestically and internationally.
- While performing the duties of this job, the noise level in the work environment is usually
