Medical Director

  • 200 Cambridgepark Dr, Cambridge, MA 02140, USA
  • Full-time

Company Description

Precision therapeutics for genetically defined diseases. Real solutions for real challenges.

Who We Are

Cogent Biosciences is a 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, CGT9486 (formerly PLX9486) 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 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.

Job Description

This is a unique opportunity for an elite, board certified clinician 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 Medical Director role, we are looking for an extremely sharp academic physician, (preference for board certified oncologist/hematologist) with experience in the conduct and oversight of clinical studies either as an academic investigator or in industry to provide medical and clinical scientific leadership for our development programs, focusing on rationale development of precision small molecules. Industry experience is not required for the Medical Director role.

Working on cross-functional multidisciplinary product teams, and leading clinical development subteams, 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.

What You Will Do:

Reporting to the VP of Clinical Sciences, you will be focused on the following activities:

  • Working with Cogent’s research teams, you will provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives as required;
  • You will provide medical and drug development analysis, critique, and interpretation of business development due diligence initiatives as required;
  • You will join specifically identified product (i.e. asset) teams as the clinical development leader, and in that capacity, you will also assume the leadership of those product teams’ clinical sub teams. In these roles, you will participate in all aspects of the overall product (i.e. asset) strategy, drive the clinical development strategy, and assume primary accountability for all aspects of the design and execution of that strategy;
  • You will provide primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation, for programs to which you are accountable;
  • As medical lead on your respective product teams, you will oversee the writing of all critical program documents pertaining to the asset’s development, including but not restricted to study protocols, the investigators’ brochure, regulatory filings and submissions, abstracts, manuscripts and publications, clinical study reports, etc.;
  • As medical lead on your respective product teams, you will 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 (CPAP), etc.;
  • As leader of cross-functional teams clinical sub teams, you will work with other team members in a collaborative manner to achieve efficient, cost effective, and high-quality design and execution of the clinical development plan, both with internal Cogent team members, external consultants and CROs, as well as study investigators, DSMCs, and other critical program stakeholders.
  • As the medical lead on your respective product teams, you will be responsible for liaising with external collaborators, medical/scientific advisors, and site investigators.

Qualifications

What You Bring

  • Board certification/eligibility in medical oncology and/or hematology. Experience with small molecules and/or precision medicine experience strongly preferred.
  • A working knowledge of biostatistics, data management, clinical operations, translational sciences, clinical pharmacokinetic scientific and other technical disciplines and processes intimate with the drug development process is required;
  • Outstanding communication skills (written and verbal, both formal and informal) are an absolute requirement;
  • Ability to manage multiple projects and initiatives simultaneously in a fast-paced environment is required;
  • Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams is absolutely required.

Additional Information

 

Our Location

Cogent is located within walking distance of the Alewife T station in Cambridge, MA. Our space includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.

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), unlimited time-off, a 401(k) plan, and commuter/parking benefits.

  • Cogent is an equal opportunity employer
  • Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals