Senior Manager, Medical Information
About the role
Who We Are
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
The Senior Manager/Manager, Medical Information, will support the execution of medical information activities for Cogent Biosciences’ portfolio and pipeline programs. This individual will serve as a key scientific resource responsible for providing accurate, balanced, timely, and compliant medical information in response to unsolicited inquiries from healthcare professionals, patients, and internal stakeholders. This role will partner closely with Medical Affairs, Pharmacovigilance, Regulatory Affairs, Legal/Compliance, Commercial, and external medical information vendors/call centers to ensure high-quality scientific exchange and compliant dissemination of medical information. In partnership with the Senior Director Medical Information, this role will support Medical Information operations, including process optimization, system oversight, vendor coordination, and operational excellence for medical information workflows and tools. The ideal candidate is a strong scientific communicator with hands-on medical information experience, including inquiry response management, development of medical response content, medical information operations, and cross-functional collaboration in a fast-paced biotech environment.
Responsibilities
- Respond to and oversee timely, accurate, and balanced responses to unsolicited medical information inquiries from healthcare professionals, patients, caregivers, and internal stakeholders.
- Serve as a medical information subject matter resource for assigned products and disease states.
- Partner with outsourced medical information call center/vendor to support inquiry fulfillment, training, escalation management, quality monitoring, and issue resolution.
- Manage the Medical Information (MIC) database from a system and operations standpoint, including oversight of user access, workflow configuration, data quality, reporting needs, and system-related documentation.
- Partner with the medical information database/system vendor to identify, track, and resolve system bugs, fixes, enhancements, and other operational needs that support compliant and efficient inquiry management.
- Serve as a liaison with the outsourced call center to triage and resolve operational issues as they arise, including system access, workflow questions, inquiry routing, documentation, and escalation processes.
- Support development, implementation, and continuous improvement of Medical Information processes, work instructions, and operational standards to ensure consistency, compliance, and efficiency.
- Ensure appropriate identification and reporting of adverse events (AEs), product