Associate Director of Clinical Operations

Role overview

The Associate Director of Clinical Trial Management is accountable for driving clinical studies from the initial protocol idea through final clinical study report delivery. This position owns day-to-day trial execution for moderately to highly complex studies, spanning different geographies, designs, and phases, while keeping milestones on track. The role also anticipates and resolves operational risks, contributes to ongoing process enhancements, and helps shape SOPs, clinical development plans, and other company priorities.

Location and reporting line

This position may be based in South San Francisco or performed remotely within the United States. The role reports to the Vice President, Clinical Operations & Development.

Key responsibilities

The Associate Director will oversee the operational side of clinical trials, from feasibility assessment and study planning through closeout support. This includes building execution plans, creating timelines and tracking metrics, coordinating vendors, and ensuring study documents, training materials, and meeting activities are prepared and maintained to a high standard.

The role also plays a major part in quality, compliance, and budget control by ensuring adherence to GCP, ICH, SOPs, and applicable regulations; maintaining inspection-ready files; reviewing monitoring outputs; coordinating responses to audit findings; and managing study budgets and invoices within approved scope and contractual terms.

In addition, this position leads cross-functional study teams, partners with internal and external stakeholders, supports site and personnel selection and training, reviews site-facing documents, and provides coaching and guidance to clinical staff. Some line-management responsibility for clinical trial management personnel may be included.

Operational duties

• Evaluate whether studies are operationally feasible and translate that assessment into practical execution plans.
• Build, monitor, and update study timelines and performance metrics.
• Support vendor strategy by helping choose external providers and overseeing their work.
• Draft vendor specifications and maintain oversight plans for key vendors such as CROs.
• Review vendor deliverables, budgets, and performance reports.
• Create or review training content for sponsor teams, CROs, CRAs, sites, and other study contributors.
• Prepare and deliver project debriefs when needed.
• Organize and lead study meetings, including Clinical Study Team meetings, Investigator meetings, DSMBs, and Advisory Committees.
• Provide operational input to refine protocol design, informed consent forms, CRFs, monitoring conventions, and edit checks.
• Build productive working relationships with investigators and site personnel.
• Manage study spend against financial targets and approve clinical invoices in line with scope and agreements.
• Coordinate with regulatory or ethics bodies as required.
• Review monitoring reports, delegated visit summaries, and site documentation to resolve issues and maintain quality.
• Support QA planning and help close out audit observations.
• Maintain complete, current, audit-ready clinical trial files, including central study documentation.
• Support the review and approval of study manuals, plans, templates, and site documents such as monitoring plans, laboratory manuals, seizure diaries, pharmacy manuals, and CRF completion guides.
• Participate in the evaluation, selection, and training of sites and internal or contract study staff.
• Guide clinical team members and, where applicable, manage direct reports.
• Work closely with Medical Monitors/Directors, Regulatory Affairs, Data Management, investigators, CROs, vendors, and other stakeholders.

Core strengths needed

• Broad experience in clinical study and project management.
• Strong written, verbal, and presentation skills.
• Highly organized with the ability to maintain dashboards and raise issues early.
• Comfort working through complex therapeutic areas and detailed protocols.
• Independent, resourceful problem-solver.
• Effective in fast-moving, uncertain, and changing environments.
• Proven leadership and team-building capability.

Physical and travel expectations

This role is primarily office-based in nature, involving extended time sitting and using standard computer equipment, which may lead to muscle strain. The employee will also regularly stand, walk, and sit, with occasional light lifting of supplies or materials. Travel may be required up to 20%.

Education and experience

A bachelor’s degree, or an equivalent blend of education and relevant experience, in a science or health-related discipline is required. Candidates should bring at least 8 years of clinical trial experience in pharmaceutical, biotech, or CRO environments, including a minimum of 5 years in trial management.

Preferred background includes at least 4 years working for a pharmaceutical or biotech sponsor on complex clinical studies and leading cross-functional teams. Experience with regulatory inspections is also preferred.

Knowledge requirements

The successful candidate should have a strong working understanding of GCP, ICH guidelines, regulatory expectations, and collaboration with Clinical Quality Assurance.