Medical Director

Who We AreCogent 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 Teamhttps://cogent.culturehq.com

This is a unique opportunity for a highly motivated, talented and experienced physician to play a key role in developing 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 Medical Director role, we are looking for a physician with clinical expertise and industry experience to provide medical oversight of assets in early and late clinical development.   Working on a cross-functional multidisciplinary team, you will drive the development strategy 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 are expected, potentially in collaboration with and supported by a clinical scientist.

Responsibilities

• 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 is strongly preferred.
• 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)
• A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, result oriented environment.
• Strong interpersonal, organization, and planning and communication skills.  Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams 

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