Cogent Biosciences

Cogent Biosciences

Senior Medical Director

Remote, United States · Director

Sponsorship not specifiedDetected 6 days ago
GCPStatisticsSAPClinical TrialsResearchLeadershipCollaborationGxP

About the role

  • You will be a key team member in the research and development organization and will be a vital part of helping to achieve the
  • You will also shape the Cogent culture and be a part of a passionate, transparent, and collaborative work environment.
  • You would be involved in supporting life cycle management opportunities and further regulatory activities for bezuclastinib in GIST.

Responsibilities

  • Collaborate with the regulatory team to develop briefing documents and other regulatory documents in support of submissions
  • Support investigator meetings, steering committee meetings, data monitoring committee reviews as the study physician.
  • You will work collaboratively with all stakeholders from internal cross functional team members to external consultants, CRO partners, key opinion leaders, investigators, and various committee members.
  • You will develop a deep understanding of the clinical and competitive environment and work with the asset team to develop the target product profile
  • 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.

Requirements

  • MD with experience in medical oncology highly preferred

Benefits

  • 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.
  • In collaboration with the Head of Clinical Development, provide strategic and medical leadership for the bezuclastinib clinical development program in GIST
  • Provide clinical and medical support to life cycle management activities in GIST as needed
  • Collaborate with commercial and medical affairs colleagues to support launch activities for bezuclastinib in GIST
  • Provide primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation for the Peak clinical trial.
  • 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.
  • Provide support to the clinical trial study team to manage safety, site education, protocol-related and eligibility questions.

Company info

  • Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent's lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.
  • 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 the GIST indication. You 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 product team, 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 in the GIST indication. You would be involved in supporting life cycle management opportunities and further regulatory activities for bezuclastinib in GIST. 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.
  • Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs.
  • Cogent's lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V.
  • KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling.
  • Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.
  • 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 the GIST indication.
  • You 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.
  • Working on a cross-functional multidisciplinary product team, 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 in the GIST indication.
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