Director, Medical Affairs Operations
Lyell Immunopharma · United States · 1 mo ago
RemoteRemoteResearch$230k–$280k/yrFull-time
About the role
Lyell is a clinical-stage company advancing next-generation CAR T-cell therapies for solid tumors and hematologic malignancies. Reporting to the Head of Medical Affairs, the Director, Medical Affairs Operations serves as the operational backbone of the growing Medical Affairs function, building and running the systems, processes, and execution engine that enable Medical Affairs to operate with speed, consistency, and compliance as the company scales toward potential launch.
Responsibilities
- Medical Affairs Operations & Business Management – Establish and run the operating cadence (annual and tactical planning, prioritization, status reporting); own budget planning, tracking, and vendor/contract management; define and report KPIs; author and maintain SOPs and operating processes; facilitate the Materials Review Committee (MRC).
- Congresses, Advisory Boards & Scientific Events – Plan and execute operational delivery of scientific congresses, symposia, and advisory boards (logistics, budgets, vendors, contracting, content routing, compliance); build calendars, playbooks, and infrastructure to scale event volume without sacrificing quality or compliance.
- Field Medical Support & Systems – Support implementation and day‑to‑day administration of core Medical Affairs systems (CRM, insights/content platforms); support field medical infrastructure, onboarding, and enablement for new MSLs; build reporting and dashboards that turn field activity and insights into decision‑ready views.
- AI Enablement & Digital Ways of Working – Serve as the AI vanguard within Medical Affairs; identify workflow pain points and resolve them through compliant AI, automation, and analytics; develop use cases, build automations and reusable workflows; create shared prompts, skills, and standards; evaluate emerging capabilities for compliant applicability.
- Cross‑Functional Coordination – Act as operational connective tissue between Medical Affairs and Clinical Development, Clinical Operations, Regulatory, Commercial, and Legal; coordinate Medical Affairs inputs to launch‑readiness workstreams.
- Compliance & Governance – Ensure Medical Affairs activities and systems comply with legal, regulatory, and corporate standards; champion responsible, compliant adoption of AI and digital tools while maintaining data integrity, confidentiality, and appropriate controls.
Requirements
- Education: Bachelor’s degree required; an advanced degree (e.g., MBA, PharmD, PhD, MS, or equivalent) preferred; familiarity with oncology, hematology, or cell therapy valued; scientific literacy an asset.
- Experience: 8+ years in Medical Affairs operations, medical excellence, business operations, or comparable operations/program management in pharma/biotech; demonstrated experience operating the core machinery of Medical Affairs (congresses, advisory boards, MRC/review, field support, budgets, KPIs); demonstrated hands‑on adoption of AI tools in real workflows (building automations, dashboards, or analyses); track record of building operating processes and systems in fast‑moving, high‑growth environments with limited infrastructure; launch or launch‑preparation experience a strong plus; strong working knowledge of U.S. compliance and regulatory requirements applicable to Medical Affairs and HCP interactions.
- Knowledge, Skills, and Abilities: Rare combination of orchestrator and doer; excellent program and project management, organizational, and prioritization skills across multiple concurrent initiatives; strong technical and analytical chops; comfort building with AI, automation, and data tools and modeling AI‑native ways of working; self‑directed operator who identifies problems and proposes solutions without prompting; exceptional collaboration and influence with medical, field, and cross‑functional leaders; high adaptability and comfort with ambiguity in a rapidly evolving, high‑growth biotech environment; strong ethical judgment, integrity, and commitment to compliance and data integrity; passion for transforming patient outcomes through cutting‑edge science and modern ways of working.
Benefits
- Eligibility to participate in Lyell’s Equity Incentive Plan.
Pay
The salary range for this position is $230,000 to $280,000 annually, with the opportunity to earn an annual bonus. The salary range is an estimate; actual salary may vary based on Lyell’s compensation practices and the applicant’s qualifications and experience.