Senior Medical Director

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 This is a unique opportunity for a highly motivated and talented physician to play a key role in the development of bezuclastinib, the lead Cogent molecule, in the GIST indication. You will be a key team member in the research and development organization and will be a vital part of helping to achieve the Cogent vision: to discover, develop, and commercialize best-in-class therapies that have a dramatic impact for patients with genetically defined diseases. Cogent is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Cogent culture and be a part of a passionate, transparent, and collaborative work environment. Working on a cross-functional multidisciplinary product team, and leading clinical development subteams, you will drive the development strategy, the design of clinical trials, and take accountability for the execution of the clinical development plan in support of the overall asset strategy in the GIST indication. You would be involved in supporting life cycle management opportunities and further regulatory activities for bezuclastinib in GIST. Primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation is expected, potentially in collaboration with and supported by a clinical scientist. Responsibilities In collaboration with the Head of Clinical Development, provide strategic and medical leadership for the bezuclastinib clinical development program in GIST Provide clinical and medical support to life cycle management activities in GIST as needed Collaborate with commercial and medical affairs colleagues to support launch activities for bezuclastinib in GIST Provide primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation for the Peak clinical trial. Design, prepare and initiate study protocols and other required documentation in compliance with project plans, federal regulations, good clinical practice (GCP) and good medical practice. Work collaboratively with matrix team members in trial execution and oversight. Provide support to the clinical trial study team to manage safety, site education, protocol-related and eligibility questions. Provide medical oversight and input into clinical trial documents including but not limited to the study protocol, informed consent form (ICF), statistical analysis plan (SAP), case report form (CRF), clinical study report (CSR) Provide medical and scientific input into other documents including but not limited to the investigators’ brochure, regulatory filings and submissions, abstracts, manuscripts and publications, clinical study reports, etc.; Collaborate with the regulatory team to develop briefing documents and other regulatory documents in support of submissions Interact with clinical trial sites, external clinical experts, contract research organizations (CROs) and regulatory agencies, as needed. Support investigator meetings, steering committee meetings, data monitoring committee reviews as the study physician. Assist with regulatory submissions by answering protocol-related questions from regulatory authorities, ethics committees and institutional review boards (IRBs) You will work collaboratively with all stakeholders from internal cross functional team members to external consultants, CRO partners, key opinion leaders, investigators, and various committee members. You will develop a deep understanding of the clinical and competitive environment and work with the asset team to develop the target product profile Qualifications MD with experience in medical oncology highly preferred Minimum of 4 years of experience in clinical development at a biotechnology or pharmaceutical company. Experience in late phase is highly preferred Critical strategic thinking to guide the clinical development program and life cycle management activities Significant knowledge and experience in the design and execution of clinical trials with experience in overseeing global clinical trials from design through execution. Experience with regulatory submissions is highly preferred. Demonstrated experience in clinical research, including designing, planning and monitoring clinical trials, particularly Phases 2-3 A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, result oriented environment. Outstanding communication skills (written and verbal, both formal and informal). Strong interpersonal, organization, and planning and communication skills. Effective skills directed toward driving collaboration, achieving results, influencing, and reaching consensus across internal and external stakeholders A working knowledge of biostatistics, data management, clinical operations, translational sciences, clinical pharmacology and other technical disciplines and processes intimate with the drug development process Salary Range $320,000 - 375,00 USD Exact compensation will vary based on skills, experience, and location. Our Locations 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 . Our Offer To You At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart . We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles . Our benefits also include a 401(k) match with immediate vesting , generous paid time off, 12 weeks of fully paid parental leave, paid family and medical leave for all employees regardless of location, and company-paid short-term disability coverage for up to 20 weeks . Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond. We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. 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. All employment is decided on the basis of qualifications, merit, and business need. #J-18808-Ljbffr