Executive Medical Director

Cogent Biosciences

About The Position

This is a unique opportunity for a highly motivated, talented and experienced physician to play a key role in designing rational precision therapies that treat the underlying cause of disease to improve patients’ lives. This position 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. For the Executive Medical Director role, we are looking for a physician with expertise in early clinical development to partner with our research and development teams and provide strategic medical and clinical scientific leadership for the growing research pipeline of precision small molecules. Industry experience in early development is required for this role. Within this role, you will contribute to the larger early development strategy and infrastructure at Cogent, as well as provide medical and clinical input into specific early programs. Working on cross-functional multidisciplinary product teams, you will advance promising drug candidates into clinical development and drive the development strategy, the design of clinical trials, and contribute to the execution of the clinical development plan in support of the overall asset strategy. Oversight of medical monitors and primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation may be required, in collaboration with and supported by a clinical scientist.

Requirements

MD required, with experience in hematology / medical oncology strongly preferred
Significant experience in clinical development at a biotechnology or pharmaceutical company; experience at a small biotech company preferred
Significant knowledge and experience in the design and execution of early phase clinical trials with experience in overseeing global clinical trials from design through execution
Demonstrated experience in clinical research, including creating clinical development plans, and designing, planning and monitoring clinical trials, particularly Phase 1 first-in-human and proof-of-concept
In-depth knowledge of regulatory requirements and compliance in clinical trials
Experience with preparing clinical sections of regulatory submissions (e.g., INDs)
Experience working in a matrix team and in direct line management
Strong understanding of targeted therapies, genetic biomarkers, and genetically defined diseases, particularly in the context of oncology
A working knowledge of biostatistics, translational sciences, clinical pharmacology, scientific and other technical disciplines and processes intimate with the drug development process
Outstanding communication skills (written and verbal, both formal and informal)
Ability to manage multiple projects and initiatives simultaneously in a fast-paced environment
Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams

Responsibilities

Work closely with Cogent’s clinical development and research teams to oversee early clinical development activities and provide strategic and medical leadership to support the growing research pipeline and early-stage assets at Cogent.
Contribute to and partner on the development of strategic initiatives and various organizational initiatives in Clinical Development.
Help develop a more structured decision-making process for which programs advance into phase 1 and subsequently beyond clinical proof of concept.
Participate in the strategic prioritization of programs in the pipeline.
Play an active role in the technical and leadership development of Clinical Development team members via management of Medical Director(s) and mentoring of team members.
Contribute to the growth of the early development organization at Cogent through development of strategies, templates, and processes to advance early-stage assets.
Participate in due diligence activities and partnership discussions when appropriate.
Provide medical, disease-specific, and development perspective for specific research programs or broader research initiatives as required.
Provide medical expertise to assess the clinical relevance and therapeutic potential of early-stage drug candidates, considering their mechanism of action and potential patient populations.
Foster strong collaborative relationships with research teams to facilitate the translation of scientific discoveries into clinical development strategies.
Review and lead the interpretation of clinical trial data and collaborate on the preparation of clinical study reports, presentations, and publications for scientific conferences and peer-reviewed journals.
Oversee the writing of all critical program documents including but not limited to study protocols, 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 IND submissions.
Provide medical input into all other documents in support of the clinical development plan.
Provide oversight of early development clinical programs ensuring execution and completion of clinical trials in alignment with regulations, ICH/GCP guidelines, and internal SOPs.
Provide and/or oversee primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation.
Foster a collaborative and high-performing team environment.
Represent the company at scientific and regulatory meetings, conferences, and advisory boards.
Work with external partners, including CROs, academic institutions, and key opinion leaders (KOLs), to ensure successful execution of clinical trials and delivery of the integrated clinical development strategy.
Develop a deep understanding of the clinical and competitive landscape and work with the asset team to develop the target product profile.