Associate Director, Clinical Operations
Cogent BiosciencesWaltham, Massachusetts, United States · Posted 1 month agoDescription
Who We Are:
Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.
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. This individual will serve as a trusted partner to the Head of Clinical Operations and will be expected to identify risks proactively, influence key stakeholders, and help scale operational excellence within a growing clinical organization.
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.
Responsibilities:
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- Serve as the clinical operations lead for one or more global clinical studies, ensuring delivery of study objectives on timeline, budget, and quality expectations. Provide strategic oversight of CROs and vendors, ensuring 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 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%).
Qualifications:
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- 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
- Multi-phase clinical trials
- Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoring
- Familiarity with clinical data review and data management processes
- Excellent knowledge of GCP, ICH, and FDA regulations
- Experience with SOP review and development
Salary Range:
$185,000- $215,000USD
Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open, collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.
Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline.
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