Associate Director, Clinical Operations: People & Functional Leadership
About The Position
The Associate Director, Clinical Operations provides line management and functional oversight for a team of 6–12 clinical trial staff across Clinical Trial Associate (CTA), Clinical Research Associate (CRA), Clinical Trial Manager (CTM), and Clinical Project Manager (CPM) levels. Trials are conducted in-house rather than outsourced to a CRO, so the role and team are directly responsible for site management, monitoring, and trial execution. Individual contributors retain day-to-day accountability for their assigned trials. The role is responsible for developing staff, allocating workload and resources across studies or programs, and ensuring consistent quality and process adherence. It also provides operational guidance, supports inspection readiness, and collaborates with cross-functional partners and senior leadership to align trial execution with program timelines and improve processes.
Requirements
- 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.
- Bachelor's degree in life sciences, nursing, or a related field.
- Ability to sit for prolonged periods.
- Ability to travel domestically and internationally.
Nice To Haves
- Advanced degree.
- Experience building or improving Clinical Operations processes, tools, and ways of working in a growing biotech environment.
Responsibilities
- Directly manage, coach, and develop a team of 6–12 clinical staff across CTA, CRA, CTM, and CPM levels.
- Conduct performance reviews, set goals, and plan career development for direct reports according to their roles and levels.
- Lead recruitment, onboarding, and training for new team members.
- Identify training needs and coordinate role-specific development.
- 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.
- Ensure team members follow ICH-GCP, SOPs, and applicable regulatory requirements across assigned trials.
- Review and approve key study deliverables, such as monitoring plans, TMF completeness, and site management plans, as appropriate to level.
- Provide hands-on guidance on site selection, initiation, monitoring, and close-out performed in-house by the team's CRAs and CTMs.
- Serve as an escalation point for site-level or protocol-execution issues that direct reports cannot resolve independently.
- Partner with QA on audit and inspection readiness and CAPA follow-up for the team's studies.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Director
