Cogent Biosciences

Cogent Biosciences

Associate Director, Clinical Operations

Waltham, Massachusetts, United States · Director

Sponsorship not specifiedDetected 20 hours ago
GCPNegotiationProcess ImprovementClinical TrialsClinical ResearchFDA RegulatoryResearch

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.
  • 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

  • Serve as the clinical operations lead for one or more global clinical studies, ensuring delivery of study objectives on timeline, budget, and quality expectations.
  • 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.
  • Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendors
  • 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.
  • 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.

Requirements

  • Minimum 6-7+ years of relevant industry clinical development experience
  • Experience with complex therapeutic platforms
  • BS/BA Degree or equivalent in science or a health-related field is preferred
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Company info

  • 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.
  • 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.
  • 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 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.

Visa & Work Authorization

  • Develop strong partnerships with external stakeholders while maintaining sponsor ownership of study execution
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This listing is sourced directly from Cogent Biosciences's careers page and normalized into a canonical job model.