Associate Director, Medical Information
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 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.
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.
Qualifications:
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.
- 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.
- 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%)
Salary Range:
$185,000 - 220,000 USD
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-site amenities, including free on-site parking and gym facilities in the building.
Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline.
Our Offer To You
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.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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