Sr. Director, Medical Information

Who We AreCogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Our Teamhttps://cogent.culturehq.com

Cogent Biosciences is seeking a dynamic and experienced Senior Director of Medical Information to lead the development and execution of the medical information function as we transition into commercialization. This role will be instrumental in building a best-in-class medical information infrastructure to support the launch of bezuclastinib in Systemic Mastocytosis (SM) and Gastrointestinal Stromal Tumors (GIST) and support medical information related to Cogent’s product pipeline. The ideal candidate will bring deep expertise in medical information strategy, operations, content development, and cross-functional collaboration in the biotech and/or pharmaceutical setting.

Responsibilities

• Strategic Leadership:
• Build and lead the Medical Information function, including strategy, systems, and processes to support product launches and lifecycle management.
• Develop and implement a global medical information strategy aligned with commercial, medical, and regulatory objectives.
• Content Development & Management:
• Oversee the creation, review, and approval of standard response documents (SRDs), FAQs, AMCP dossier(s), and other scientific materials.
• Ensure scientific accuracy, compliance, and alignment with product labeling and regulatory requirements.
• Medical Inquiry Management:
• Establish and manage a medical inquiry system and response process, including oversight of vendors and call centers.
• Monitor inquiry trends and provide actionable insights to internal stakeholders.
• Cross-Functional Collaboration:
• Partner with Medical Affairs, Regulatory, Legal, Commercial, and Pharmacovigilance to ensure consistent and compliant communication of scientific information.
• Support field medical teams (MSLs) with scientific resources and training.
• Launch Readiness:
• Lead medical information launch planning and execution for bezuclastinib in SM and GIST.
• Develop global and regional launch materials and ensure readiness of systems and processes.
• Compliance & Governance:
• Ensure all medical information activities comply with applicable laws, regulations, and industry standards (e.g., PhRMA, FDA, EMA).
• Participate in internal audits and inspections as needed.

Qualifications

• Advanced degree (PharmD, PhD, MD, NP, PA, etc.) in a scientific discipline required.
• Minimum of 10 years of experience in Medical Information within the biotech/pharmaceutical industry, with at least 5 years in a leadership role.
• Proven experience supporting the build of the Medical Information function to support oncology and/or rare disease product launches; experience with Systemic Mastocytosis and/or GIST is a strong plus.
• Deep understanding of regulatory and compliance frameworks (FDA, EMA, OIG, PhRMA).
• Demonstrated success in building and scaling medical information functions in a fast-paced, evolving environment.
• Strong leadership, communication, and project management skills.
• Experience with medical information systems (e.g., IRMS, Veeva Vault) and content management platforms.
• Experience in Medical Legal Regulatory of external-facing documents, medical and promotional, and the ability to work collaboratively with the responsible team members; initially leading the review process to represent the Medical review while establishing a plan for the appropriate level of support required by the Medical Information function to facilitate review and approval of documents in preparation for and through product launch(es) and product indication expan