Medical Director Senior Medical Director

Who We Are

Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.

Our Team

https://cogent.culturehq.com/

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 Systemic Mastocytosis. Reporting to VP, Head of Clinical Development, the Medical Director 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 strategy team, 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. 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

• Participate in all aspects of the overall asset strategy, drive the clinical development strategy, and assume accountability for the execution of that strategy in SM.
• Collaborate with team members to develop and execute the clinical development plan.
• Work collaboratively with all stakeholders from internal cross functional team members to external consultants, CRO partners, key opinion leaders, investigators, and various committee members.
• 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.
• Provide scientific, clinical development and medical input into all other program documents in support of the development plan, including but not limited to informed consent forms (ICF), case report forms (CRF), statistical analysis plans (SAP), and clinical pharmacology/translational medicine plans, etc.
• Develop a deep understanding of the clinical and competitive environment and work with the strategy team to develop the target product profile. As the clinical trial physician:- Provide primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation.
• 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)
• 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

Qualifications

• MD with at least 2 years of experience in drug development (industry or clinical trial experience) including experience in conducting and managing clinical trials. Board certification/eligibility in medical oncology, hematology, or allergy/immunology is highly preferred.
• 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 clinical trial regulations, GCP, biostatistics, data management, clinical operations, translational sciences, clinical pharmacology and other technical disciplines and processes intimate with the drug development process.