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.ย
The Role:
Cogent Biosciences isย seekingย an experienced and highly motivatedย Associate Director, Clinicalย Operationsย 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.ย
ย 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.ย
ย 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 toย identifyย risks proactively, influence key stakeholders, and help scale operational excellence within a growing clinical organization.ย
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.ย
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Responsibilities:
- Serve as the clinical operations lead for one or more global clinical studies, ensuring delivery of studyย objectivesย on timeline, budget, and quality expectations.ย Provide strategic oversight of CROs and vendors, ensuring accountability, quality, and operational execution.ย
- Develop and reviewย study performance metrics and drive corrective and preventive actions when needed.ย Evaluate and analyze site trends, evaluate study risks and mitigation strategies, and work with the cross-functional team in theย reviewย clinical data.ย
- Develop strong partnerships with external stakeholders whileย maintainingย sponsor ownership of study execution.ย Serve as Clinical Operations representative on Strategyย Teams, andย coordinate and lead study team meetings and update theย cross-functionalย Team on timelines and milestones for the study.ย ย
- Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, designing CRFs, andย ensureย proper team and external training.ย
- Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.ย
- Support the evaluation of study vendors, including negotiation of contracts and budgets with CROs, clinical sites and vendorsย
- Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, training, motivational, and sponsor oversight visits, as neededย
- Ensure that study documentation isย maintainedย according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.ย
- Collaborate with Clinical, Regulatory, and Quality team members to ensure complianceย ofย department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs.ย
- Limited travel possible toย clinicalย sitesย for investigator and site engagement, with potential toย travelย ย (~25%).ย
Qualifications:
- BS/BA Degree or equivalent in science or a health-related field is preferredย
- Minimumย 6-7+ย years of relevant industry clinical development experienceย ย
- Experience with complex therapeutic platformsย ย
- Multi-phaseย clinical trialsย ย
- Experience with all aspects of trial and site startup and vendor selection and management, study management, and monitoringย
- Familiarity with clinical data review and data management processesย
- Excellent knowledge of GCP, ICH, and FDA regulationsย
- Experience with SOP review and developmentย
Salary Range:
$185,000- $215,000USDย
Target Bonus: 20%
Exact compensation will vary based on skills, experience, and location.
Our Locations
Waltham, MA: Ourย headquarters is located in the Greaterย Bostonย life sciencesย community, withย an open, collaborative office environment designedย to support teamwork and connection. Employeesย benefitย from convenient on-site amenities, including freeย on-site parking and gym facilities in the building.ย
Boulder, CO:ย Our Boulder location is home toย Cogent'sย discovery research organization and a key scientific hub with strong leadershipย based on site. Situated in the greater Denver-Boulderย biopharmaceutical corridor, this office playsย a central roleย in advancing our discovery efforts andย pipeline.ย
Our Offerย Toย Youย
At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package thatย sets us apart.ย We cover 100% of medical, dental, and vision premiums for you and your family,ย andย helpย reduceย out-of-pocket costs by funding up to 75% of in-network deductibles.ย Our benefits also includeย a 401(k) match with immediate vesting,ย generous paid time off,ย 12 weeksย of fully paid parental leave, paidย familyย and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up toย 20 weeks.ย Additionalย perksย likeย wellnessย programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.ย
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce.ย We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law.ย All employment is decided on the basis of qualifications, merit, and businessย need.ย