Associate Director, Medical Information

Cogent Biosciences • Waltham, MA

5h

About The Position

The Associate Director (AD), Medical Information is a core member of the Medical Information function at Cogent Biosciences, who will have a strong focus on launch readiness, Medical‑Legal‑Regulatory Committee review, and cross‑functional collaboration. The AD will also contribute to the development and implementation of the Medical Information strategic plans.

Requirements

• Advanced scientific or clinical degree (PharmD, PhD, MD, or equivalent).
• Minimum 7–10 years (Associate Director) 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.
• 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.
• Experience shaping Medical Information strategy and plans, including launch planning and lifecycle management.
• 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%)

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart.
• We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles.
• Our benefits also include a 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 regardless of location, and company-paid short-term disability coverage for up to 20 weeks.
• Additional perks like wellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree