Senior Manager, Medical Information

About this 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 quality complaints, and special situations in partnership with Pharmacovigilance and the Quality team.

• Develop, review, update, and maintain standard response documents (SRs), reactive materials (including payor materials), and scientific response content for approved and pipeline products.

• Research, analyze, and interpret scientific literature to support custom medical responses and scientific exchange.

• Lead and/or support development of custom responses for complex or escalated medical inquiries.

• Maintain version control and ensure medical information content remains current, scientifically balanced, and compliant.

• Collaborate with Medical Affairs, Clinical Development, Regulatory, Legal/Compliance, Commercial, Market Access and Safety colleagues to support aligned and compliant medical information practices.

• Contribute medical information insights and trends to support Medical Affairs strategy and customer understanding.

• Ensure activities comply with FDA regulations, company SOPs, and industry standards governing unsolicited medical requests and scientific exchange.

• Support Medical/Legal/Regulatory (MLR) review activities as needed and develop understanding of promotional and non-promotional review processes.

Qualifications:

Advanced clinical or scientific degree preferred (PharmD, PhD, NP, MD, or other relevant life sciences degree).

• 5+ years of experience in Medical Information, Medical Affairs, pharmaceutical/biotechnology industry, or relevant clinical practice experience; oncology, hematology, rare disease and/or payor experience preferred.

• New product launch experience preferred

• Strong medical writing and literature evaluation skills. And the ability to communicate complex scientific information.

• Excellent communication and cross-functional collaboration skills.

• Strong organizational skills and ability to manage multiple priorities in a fast-paced environment.

• Understanding of regulations and guidance related to unsolicited medical information requests and scientific exchange.

• Ability to travel to internal meetings and scientific congresses (~15%)

Salary Range:

$150,000 - 190,000 USD

Target Bonus: 15%

Exact compensation will vary based on skills, experience, and location.

Our Locations

Waltham, MA: Our headquarters is located in the Greater Boston life sciences community, with an open , collaborative office environment designed to support teamwork and connection. Employees benefit from convenient on-

Similar jobs

• Manager, Medical Information — Azuritypharmaceuticalsindia · Hyderabad, IN
• Senior Director, Medical Information — Dynetherapeutics · Remote
• Director, Medical Information — Beamtherapeutics · Cambridge, MA
• Senior Manager, Medical Affairs Operations — Braeburn · Plymouth Meeting, PA (Hybrid) or Remote
• Senior Manager, US Medical Affairs — Dynetherapeutics · Waltham, MA
• Senior Manager, Clinical Data Management — Corcepttherapeutics · Redwood City, California, United States
• Senior Director/VP, Medical Affairs — Clicktherapeutics · New York, NY, Boston, MA or Remote
• Sr. Manager, Regulatory Affairs — Vaxcyte · San Carlos, California, United States