Cogent Biosciences

Compensation

Full Description

Who We Are Cogent Biosciences is a publicly traded biotechnology company dedicated to developing precision therapies for genetically defined diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease and offer meaningful hope to patient's. The company’s lead therapeutic candidate, bezuclastinib, is a highly selective tyrosine kinase inhibitor designed to potently target KIT D816V and other mutations in KIT exon 17. These mutations are known drivers of systemic mastocytosis (SM) and advanced gastrointestinal stromal tumors (GIST) - both serious conditions driven by oncogenic KIT signaling. Bezuclastinib is currently being evaluated in multiple registration-directed trials across Non-Advanced SM (NonAdvSM), Advanced SM (AdvSM), and GIST. In July 2025, Cogent announced that its registration-direct SUMMIT trial in patients with NonAdvSM achieved statistical significance across all primary and key secondary endpoints, and the company is on track to file its first New Drug Application for this patient population by the end of 2025. The company also remains on track to announce top-line results for its APEX trial in patients with AdvSM in the second half of 2025 and for its PEAK trial in patients with GIST by the end of 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor, and the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting other serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS. Through its commitment to precision medicine and targeted innovation, Cogent Biosciences is working to transform the treatment landscape for patients with serious and underserved diseases. By leveraging validated biology and a rational drug discovery approach, Cogent aims to create real solutions that address the underlying drivers of disease. Our culture of inquisitiveness fuels continuous learning and innovation; we challenge assumptions, ask bold questions, and embrace a mindset of discovery to uncover transformative insights. The Role The Associate Director, Investigator-Initiated Trials & Expanded Access Programs will play a critical role in ensuring continued access to investigational therapies prior to commercialization. This role bridges between Clinical Operations and Medical Affairs and will lead the strategic development and operational oversight of the company's Expanded Access Programs (EAPs), Investigator-Sponsored Trials (ISTs), and Rollover Protocols. This role is responsible for ensuring compliant, efficient, and ethical execution of these programs in alignment with corporate strategy, global regulations, and Good Clinical Practice (GCP). The Associate Director will implement and oversee programs that enhance the patient experience, support trial retention, and maintain compliant access to study drugs beyond clinical trial enrollment. The ideal candidate will have a strong background in clinical operations, project management, and bring strong cross-functional leadership, regulatory knowledge, and a deep commitment to patient-centered care. Key Responsibilities • Expanded Access Program (EAP) Lead • Design, implement, and manage expanded access strategies for Cogent products in compliance with global and country level regulatory requirements and internal SOPs. • Lead cross-functional collaboration to enable timely decision-making, allocate resources efficiently, and maintain a seamless flow of information to internal and external partners. • Oversee all aspects of the program, including timelines, budget, and resources. • Collaborate with legal, pharmacovigilance, supply chain, and relevant cross functional teams to support access and distribution. • Provide training and ongoing support to physicians on EAP program requirements, partnering with Medical Affairs on outreach/engagement strategy supporting access to patients • Contribute to the development of policies and strategies aligned with product lifecycle and global access objectives. • Identify potential risks and develop mitigation strategies. • IST (Investigator-Sponsored Trials) Operational Lead • In partnership with Medical Affairs, provide operational support for Investigator-sponsored Trials • Develop and implement processes to ensure consistent and efficient IST program execution, including tracking project timelines, managing risks, and coordinating with investigators. • Rollover Programs • * Develop, plan, and manage all aspects of clinical trial rollover programs, from feasibility and startup through closeout. • Serve as the primary point of contact for and collaborate with internal and external stakeholders, including Medical Affairs, Regulatory Affairs, investigators, and Contract Research Organizations (CROs). • Ensure all program activities adhere to Good Clinical Practice (GCP), ICH guidelines, and all applicable national and international regulatory requirements. • Develop and implement strategies to ensure efficient patient enrollment and retention within the extension program • Oversee the creation of patient-facing materials, tools, resources to improve continued trial engagement and retention Qualifications • A bachelor's degree in life science, medicine, or a pharmacy-related field is required. An advanced degree (e.g., MS, MPH, PharmD, PhD) is strongly preferred. • 8+ years of relevant experience in the pharmaceutical or biotech industry, with a minimum of 3 years of direct experience managing EAP and/or IST programs. • Demonstrated experience in a leadership or senior role with responsibility for program strategy and oversight. • Regulatory expertise: In-depth knowledge of GCP, FDA regulations governing Expanded Access (21 CFR Part 312), and ethical considerations for clinical research. • Leadership and influence: Proven ability to lead cross-functional teams and influence internal and external stakeholders without direct authority. • Communication: Excellent communication and interpersonal skills, with the ability to navigate sensitive topics with patients and external partners. • Business acumen: Strong financial management skills for budget oversight and contract negotiation. Salary Range 160,000 - 205,000 $USD Target Bonus: 20% Exact compensation will vary based on skills, experience, and location. Our Locations Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building. Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization. Our Offer To You To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits. 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.