Senior Director of Clinical Operations

About the role

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Director of Clinical Operations based in United States. This is a senior clinical operations leadership role with direct ownership of the delivery of a clinical-stage therapeutic trial. You will oversee clinical and regulatory execution from study start-up through close-out, with accountability for quality, timelines, and budget. The role combines hands-on trial leadership with portfolio-level influence across clinical operations, quality, regulatory strategy, and technology. You will make real-time decisions on safety, protocol interpretation, trial methodology, and operational risks while supporting the wider clinical portfolio. The position offers close collaboration with senior medical, operations, quality, product, and corporate development stakeholders. You will help establish scalable SOPs, systems, and clinical delivery standards as the organization advances toward increasingly complex trials. This is an opportunity to shape clinical operations at a growing, technology-enabled biopharma organization while remaining closely involved in trial execution.

Responsibilities

• Own clinical delivery for an assigned clinical-stage therapeutic asset from study start-up through close-out.
• Maintain accountability for clinical and regulatory execution, study quality, timelines, and budget.
• Work closely with and provide leadership to the Clinical Program Manager responsible for day-to-day trial execution.
• Make and guide real-time clinical, safety, quality, protocol, and trial methodology decisions.
• Proactively identify, assess, and mitigate operational and clinical risks throughout the study lifecycle.
• Contribute to the clinical development plan for the assigned asset and collaborate with relevant program leadership.
• Provide senior clinical operations expertise across a portfolio of multiple clinical-stage assets.
• Help build clinical operations and regulatory capabilities as the portfolio moves toward more complex, FDA-facing trials.
• Establish and maintain high standards for clinical monitoring, oversight, quality, and operational execution.
• Lead or contribute to the development and refinement of clinical operations SOPs and processes across the portfolio.
• Partner with Quality leadership to ensure processes, controls, and documentation support consistent trial quality.
• Provide clinical delivery input into the design and evolution of clinical trial technology, including EDC, CTMS, eTMF, and other operational systems.
• Collaborate with technology and product teams to ensure clinical systems effectively support trial delivery.
• Guide, mentor, and support the professional development of members of the broader Clinical Operations team.
• Serve as a senior authority for operational and quality decisions across the clinical portfolio.
• Provide portfolio-level sign-off and oversight on safety, trial design, proportionality, and essential clinical documentation.
• Review and provide senior oversight of key trial materials, including monitoring plans, risk assessment and mitigation plans, protocol deviations, and eTMF readiness.
• Apply a proportionate, risk-based approach to clinical oversight, focusing resources on the areas of greatest clinical and operational risk.
• Advise less-experienced clinical operators while encouraging appropriate ownership and decision-making within trial teams.
• Collaborate with cross-functional leaders to resolve clinical, operational, safety, quality, and regulatory issues.

Requirements

• 15+ years of experience in clinical operations with substantial hands-on delivery experience across multiple Phase 2 drug trials.
• Demonstrated experience working on complex neurology trials in chronic indications, ideally including Parkinson’s disease.
• Extensive firsthand experience making clinical, quality, and safety judgments in real time across multiple clinical trials.
• Proven experience providing senior review and sign-off on essential trial documentation.
• Strong knowledge of monitoring plans, risk assessment and mitigation plans, protocol deviations, eTMF readiness, and related clinical operations documentation.
• Demonstrated ability to apply a proportionate, risk-based approach to clinical oversight rather than relying solely on checklist-based processes.
• Experience contributing to or leading SOP and process design at a portfolio or functional level.
• Broad experience across different clinical trial types, phases, and therapeutic areas.
• Strong judgment and ability