Clinical Operations Associate Director

Role Summary

The Clinical Operations Associate Director combines end-to-end design, execution, and reporting of oncology clinical trials with leadership in study teams and across matrix teams. This position is responsible for planning and leading the delivery of studies to time, quality, and budget, aligned with the clinical study protocol. The role serves as the Study Delivery Lead (SDL) and leads the Study Delivery Team across in-house, outsourced, and alliance delivery models.

Responsibilities

• Accountable for the global study delivery strategy and overall study deliverables.
• Guide assessment, selection, engagement, management, and oversight of vendors.
• Ensure compliance with ICH/GCP guidelines, applicable laws and regulations, and company SOPs for designated studies.
• Make decisions balancing risk/benefit with impact on the study; mitigate risk where appropriate.
• Collaborate to develop and manage study-level budgets within project allocation.
• Prepare materials for internal governance and financial review cycles.
• Build relationships and collaborate with aligned staff in other functions.
• Encourage matrix and line teams to seek alternative perspectives and develop solutions.
• Lead and conduct investigator meetings and other study-related meetings; participate in governance meetings as necessary.
• Identify and communicate resource gaps for assigned studies.
• Lead risk management and quality efforts to ensure study compliance and inspection readiness.
• Lead or contribute to process improvement initiatives.
• Provide expert clinical operational input into protocol development.
• Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study.
• As the SDL, lead the SDT and collaborate with SDT members.
• Develop patient-centric documents and address patient burden with appropriate functions.
• Engage Clinical Operations staff in process development, problem solving, and training initiatives as needed.
• Provide proactive oversight of CRO and vendor performance.
• Support study-level status updates focusing on delivery to corporate and project objectives.

Qualifications

• Required: BS/BA with a minimum of 11 years of related experience; or MS/MA with a minimum of 9 years; or PhD/PharmD with a minimum of 5 years; or equivalent combination of education and experience.
• Experience in Biotech/Pharmaceutical industry preferred; management experience including outsourcing to CROs.

Knowledge / Skills

• Extensive clinical development experience with at least 6 years as a global study leader, delivering studies on time, cost, and quality in pharma/biotech or CRO settings.
• Operational experience leading high-performing global study teams in Oncology trials.
• Ability to identify and resolve issues to ensure timely delivery; strong leadership, influencing, and negotiation skills.
• Experience leading in a matrix environment to deliver projects, develop clinical plans, and manage change.
• Knowledge of either study management or data management and global regulatory guidelines (ICH/GCP).
• Experience working with investigators, external experts, regulatory agencies; oversight of CROs and third-party vendors; ability to realign CROs when at-risk and conduct after-action reviews.
• Ability to build internal and external relationships in a dynamic, matrixed environment.
• Strong project and budget management skills; able to author patient-facing materials, study procedures manuals, pharmacy manuals, and ICFs.
• Broad expertise to contribute to company objectives and adapt policies as needed.
• Excellent analytical and business communication skills.

Education

• BS/BA, MS/MA, or PhD/PharmD in a related field with corresponding years of experience as listed above.

Additional Requirements

• Travel may be required up to 20% in support of clinical study activities.