Senior Medical Director
Job description
About the role
Cogent Biosciences is seeking a Senior Medical Director to assume ownership of the medical strategy and execution for bezuclastinib within the specific indication of gastrointestinal stromal tumor (GIST). This is a remote position based in the United States where the successful candidate will provide strategic and medical leadership that guides the development program from protocol design through lifecycle management. The hire will carry direct accountability for clinical trial oversight, safety review, and contributing to both regulatory and commercial outcomes in alignment with corporate objectives. This individual will operate within a cross-functional team and influence the collaborative culture at Cogent to ensure scientific and medical excellence. The role is responsible for owning the medical direction for bezuclastinib in GIST, aligning specifically with the development programs named APEX (AdvSM), SUMMIT (NonAdvSM), and PEAK (GIST).
Key facts
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Location: Remote (USA)
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Engagement: Remote, United States
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Compensation: $240,000 on an annual basis (salary)
What you'll do
You will steer the clinical strategy for bezuclastinib in GIST, providing medical leadership across the entire development program from conception to maturity. A core responsibility involves serving as the primary medical monitor for the PEAK trial, overseeing subject safety and clinical data review and interpretation to ensure rigorous standards. You will design, prepare, and initiate study protocols and associated documentation in strict compliance with project plans, federal regulations, good clinical practice (GCP), and good medical practice to maintain audit readiness. You will collaborate with matrix team members to advance trial execution, resolve protocol-related questions, and support site education to ensure consistent implementation across global sites. This includes coordinating closely with clinical operations, biostatistics, and regulatory functions to integrate medical insights into every stage of development. You will provide essential medical input into key documents such as the investigators' brochure, regulatory filings and submissions, abstracts, manuscripts, publications, and clinical study reports to ensure accurate and compelling scientific communication. The role requires active participation in interactions with ethics committees, regulatory bodies, and study leadership during scientific and regulatory reviews to advocate for scientifically sound decisions. You will build deep expertise in GIST and the competitive oncology landscape to help define the target product profile and differentiate the asset in the marketplace. You will partner with contract research organizations (CROs), key opinion leaders, and global study sites to ensure robust, high-quality, and compliant trial conduct that generates reliable data. You will also provide strategic and medical leadership for life cycle management opportunities and support the planning of launch activities in coordination with commercial teams to bridge development and market access.
Requirements
The position requires an active Medical Doctor (MD) degree as a non-negotiable baseline qualification for practicing medicine in this role. Board certification in medical oncology is strongly preferred given the leadership role in bezuclastinib development and the complexity of the GIST indication. A minimum of four years of clinical development experience within a biopharmaceutical company is required, ensuring familiarity with the operational and regulatory nuances of the industry. Candidates must demonstrate a proven capacity to provide strategic guidance for complex clinical programs and manage the full lifecycle of investigational agents from initiation to completion. Extensive experience in designing, executing, and overseeing global clinical trials is essential to ensure studies are scientifically sound, ethically conducted, and compliant. This includes providing regulatory submission support and ensuring compliance with GCP and applicable health authority requirements to maintain study integrity and approvals. The ideal candidate will have the ability to synthesize complex clinical data and translate it into actionable medical strategies that guide decision-making. Strong communication skills are mandatory to effectively interact with cross-functional teams, regulatory authorities, and external stakeholders at all levels of the organization. The role demands a high degree of accountability and independence, as the Senior Medical Director will act as a key medical authority for the program. Proficiency in interpreting clinical trial data, safety signals, and efficacy trends is required to drive the development program forward successfully.
Nice to have
Prior clinical experience with mastocytosis or GIST development programs is a distinct advantage for this specific role and should be highlighted in the candidate profile.
Practical notes
This is a remote role based in the United States. Travel may be required for meetings, scientific conferences, or trial oversight activities as needed to fulfill the responsibilities of the position. The role involves direct oversight of the PEAK clinical trial and demands close collaboration with cross-functional teams, CROs, and regulatory stakeholders to ensure the highest standards of medical review and data integrity are maintained at all times.