Associate Director, Clinical Operations

About the role

Cogent Biosciences is seeking an experienced and highly motivated Associate Director, Clinical Operations to serve as a key operational leader across our clinical development programs. Reporting to the Senior Director, Head of Clinical Operations, this individual will function as both a hands-on study leader and a strategic clinical operations partner, helping drive execution and operational excellence across multiple stages of development. This role is ideal for someone who enjoys balancing operational detail with strategic program oversight - an individual who can independently lead complex global studies while also contributing to broader Clinical Operations strategy, portfolio planning, process improvement, and cross-functional decision-making. The successful candidate will be accountable for the planning, execution, oversight, and delivery of clinical trials across early-stage development programs, with opportunities to support later-stage development as programs advance. We are seeking someone who brings strong operational expertise, a sense of ownership, intellectual curiosity, and a willingness to work at both the strategic and tactical levels. The ideal candidate is equally comfortable reviewing site-level enrollment challenges, leading vendor governance discussions, influencing development strategy teams, and driving complex cross-functional initiatives.

Key facts

What you'll do

• Serve as the clinical operations lead for one or more global clinical studies, ensuring delivery of study objectives on timeline, budget, and quality expectations while providing strategic oversight of CROs and vendors to ensure accountability, quality, and operational execution.
• Develop and review study performance metrics and drive corrective and preventive actions when needed; evaluate and analyze site trends, evaluate study risks and mitigation strategies, and work with the cross-functional team in the review of clinical data.
• Develop strong partnerships with external stakeholders while maintaining sponsor ownership of study execution; serve as Clinical Operations representative on Strategy Teams, and coordinate and lead study team meetings and update the cross-functional Team on timelines and milestones for the study.
• Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, designing CRFs, and ensure proper team and external training.
• Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
• Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors.
• Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, motivational, and sponsor oversight visits, as needed.
• Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.
• Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.
• Limited travel possible to clinical sites for investigator and site engagement, with potential to travel (~25%).

Requirements

• BS/BA Degree or equivalent in science or a health-related field is preferred.
• Minimum 6-7+ years of relevant industry clinical development experience.
• Experience with complex therapeutic platforms.
• Demonstrated ability to manage multiple priorities and competing demands in a fast-paced, dynamic environment.
• Strong written and verbal communication skills and ability to influence and negotiate with cross-functional stakeholders.
• Proficiency with Microsoft Office and clinical trial management systems.
• Willingness to travel approximately 25% domestically to clinical sites for study monitoring, stakeholder meetings, and vendor management activities.
• Must be able to work in Waltham, Massachusetts, or the designated U.S. location for this role.
• Must comply with all company policies and procedures, including those governing conduct, ethics, and confidentiality.

Nice to have

Only items explicitly noted as preferred in the source are listed; no additional preferences have been introduced.

Practical notes

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Engagement: Full-time.

• Travel: Approximately 25% domestic travel to clinical sites for study monitoring, stakeholder meetings, and vendor management activities.

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Location: Position is based in Waltham, Massachusetts, United States.

• Deadlines: No specific application deadline is provided in the source; interested candidates are encouraged to apply in a timely manner.
• Visa: No visa sponsorship information is provided in the source.