Associate Director, Medical Information

Role Overview

• Lead the Medical Information strategy aligned with Cogent Biosciences’ clinical development and commercialization plans
• Assist with establishing Medical Information governance, best practices, and operational standards across the organization
• Lead Medical Information launch readiness activities; primary focus on acting as Medical Lead for Medical‑Legal‑Regulatory Review Committees
• Additional activities include development, review and approval of FAQs, SRLs, and reactive content to support pre‑ and post‑launch needs
• Act as a primary Medical Affairs representative on PRC/MRC review committees, with accountability for scientific accuracy and balance, of materials
• Drive alignment between Medical Information, Medical Affairs, Patient Advocacy, Regulatory, Legal, Clinical, and Commercial teams to ensure consistent messaging at launch
• Partner closely with Medical Affairs leadership, Clinical Development, Regulatory Affairs, Commercial, Patient Advocacy, and Market Access to support enterprise‑wide objectives
• Serve as a scientific subject matter expert for products and pipeline assets to execute on deliverables
• Develop medical information content, data on file and call center materials as required
• Assist with the intake and fulfillment of unsolicited requests as needed
• Generate reports and lead the analysis of medical inquiry trends and insights to inform Medical Affairs strategy, evidence generation, and stakeholder education
• Assist with monitoring key performance indicators (KPIs) to ensure quality, timeliness, and impact of Medical Information deliverables as needed
• Use insights to drive continuous improvement of content, processes, and customer engagement
• Assist with the oversight of Medical Information operations, including inquiry management processes, systems, and external vendors or call centers as applicable
• Ensure alignment with SOPs, quality standards, and inspection readiness requirements
• Comply with all applicable guidelines, policies, and legal, regulatory, and compliance requirements
• Assist Medical Information Leadership with key projects, as needed

Requirements

• Advanced scientific or clinical degree (PharmD, PhD, MD, or equivalent)
• Minimum 7–10 years of pharmaceutical or biotechnology industry experience within Medical Information, Medical Affairs, or related scientific functions
• Deep understanding of Medical Information regulations, compliance requirements, and MLR review processes, particularly in a launch setting
• Experience in hematology, oncology, and/or rare diseases preferred
• Experience working in clinical stage companies transitioning to commercial stage and build-out of Medical Information function preferred
• Previous new product launch experience
• Demonstrated ability to lead cross‑functional teams and work collaboratively in a matrix organization
• Strong strategic thinking, decision‑making, and problem‑solving capabilities
• Excellent written and verbal communication skills, with the ability to translate complex data into clear, compliant scientific messages
• Knowledge of FDA regulations regarding the dissemination of Medical Information, and adverse event and product quality complaint reporting
• Ability to travel to scientific congresses and internal meetings as needed (~15%)

Benefits

• Health insurance
• 401(k) match with immediate vesting
• Generous paid time off
• 12 weeks of fully paid parental leave
• Paid family and medical leave for all employees
• Company-paid short-term disability coverage for up to 20 weeks
• Wellness programs
• Tuition reimbursement
• Inclusive family-forming support