Director, Medical Information

📋 Description • Architect and launch Orca Bio’s first-ever global Medical Information (MI) capability, building the function from zero to a fully compliant, audit-ready operation that will support patients, physicians, and payers across North America, Europe, and beyond. • Own the end-to-end design of the MI operating model: budget, staffing plan, vendor selection, SOPs, technology stack (Veeva Vault MedInquiry, CRM integration, telephony), quality agreements, KPIs, and governance charters that meet FDA, EMA, PMDA, and other regional regulations. • Stand up and continuously oversee a multilingual Medical Information call center—select vendors, negotiate contracts, train agents, monitor call quality, and ensure 24/7 coverage for urgent oncology inquiries while maintaining average speed-to-answer <30 seconds and customer satisfaction >90%. • Serve as the scientific gatekeeper for all outbound medical content: author, review, and approve standard response documents, medical letters, slide decks, and congress materials; ensure every asset is evidence-based, fair-balanced, and aligned with the latest peer-reviewed literature and internal data. • Chair the Medical Review Committee and sit on the Promotional Review Committee, providing final sign-off on advertising, sales training modules, and digital campaigns to safeguard scientific accuracy and mitigate regulatory risk. • Build and maintain a living library of MI resources—FAQs, dossiers, visual aids, and patient-friendly summaries—leveraging AI search and natural-language processing so field teams can retrieve answers in <10 seconds. • Partner with HEOR to infuse real-world evidence and health-economic data into AMCP dossiers and Global Value Dossiers, ensuring submissions withstand payer scrutiny and accelerate market access. • Design intuitive, real-time dashboards that translate MI query data into actionable insights for R&D, Commercial, and Market Access teams; identify emerging safety signals, competitor intelligence, and educational gaps. • Establish seamless AE/PQC intake workflows with Drug Safety and QA, mapping call-center scripts to MedDRA coding and ensuring 100% of events are captured, triaged, and reported within regulatory timelines. • Lead congress strategy: plan booth content, deliver live scientific presentations, staff the MI help-desk, and capture field insights that feed back into evidence-generation plans. • Train cross-functional colleagues—sales, MSLs, clinical operations—on MI processes, compliant inquiry handling, and the art of translating complex cell-therapy science into clear, compassionate language. • Foster a culture of urgency, curiosity, and patient-centricity; mentor junior scientists and empower the broader Medical Affairs team to challenge the status quo and accelerate access to life-saving therapies.