About this Director, Medical Affairs Operations role at Lyell Immunopharma
Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.
Reporting to the Head of Medical Affairs, the Director, Medical Affairs Operations is the operational backbone of Lyell’s growing Medical Affairs function. As the team scales toward potential launch, this role builds and runs the systems, processes, and execution engine that allow Medical Affairs to operate with speed, consistency, and compliance — spanning scientific congresses and advisory boards, the Materials Review Committee (MRC), field medical support, budget and vendor management, and performance metrics.
This is a role for a rare orchestrator-operator: someone who can design the operating model and also personally execute — building the trackers, dashboards, and AI-enabled workflows themselves rather than only sponsoring them. The Director is expected to be an AI vanguard within Medical Affairs, modeling AI-native ways of working for the team by demonstration rather than advocacy.
KEY ROLE AND RESPONSIBILITIES
Medical Affairs Operations & Business Management
- Establish and run the operating cadence of Medical Affairs — annual and tactical planning, prioritization, and status reporting — in partnership with the Head of Medical Affairs and functional leads.
- Own budget planning, tracking, and vendor and contract management for the Medical Affairs function.
- Define and report Key Performance Indicators (KPIs) and metrics that measure the quality, impact, and efficiency of Medical Affairs activities.
- Author and maintain Medical Affairs operating processes and SOPs, ensuring the function is audit-ready and launch-ready.
- Facilitate the Materials Review Committee (MRC) — intake, cadence, action tracking, and storage and disbursement of final deliverables.
Congresses, Advisory Boards & Scientific Events
- Plan and execute the operational delivery of scientific congresses, symposia, and advisory boards — logistics, budgets, vendors, contracting, content routing, and compliance — in partnership with the medical and field teams.
- Build the calendar, playbooks, and infrastructure that let the team scale event volume without sacrificing quality or compliance as the pipeline advances.
Field Medical Support & Systems
- Support the implementation and day-to-day administration of core Medical Affairs systems (e.g., CRM, insights and content platforms), driving consistent, high-quality use across the team.
- Support field medical infrastructure, onboarding, and enablement as new MSLs are integrated
- Build the reporting and dashboards that turn field activity and insights into decision-ready views for Medical Affairs leadership.
AI Enablement & Digital Ways of Working
- Serve as the AI vanguard within Medical Affairs — identifying workflow pain points and resolving them through targeted, compliant application of AI, automation, and analytics tools.
- Develop use cases, build automations and reusable workflows, and create the shared prompts, skills, and standards that make AI-native work the default across the team.
- Evaluate emerging capabilities and surface those with meaningful, compliant applicability to Medical Affairs.
Cross-Functional Coordination
- Serve as the operational connective tissue between Medical Affairs and the rest of the organization — Clinical Development, Clinical Operations, Regulatory, Commercial, and Legal.
- Coordinate Medical Affairs inputs to launch-readiness workstreams in partnership with cross-functional teams.
Compliance & Governance
- Ensure Medical Affairs activities and systems comply with legal, regulatory, and corporate standards.
- Champion the responsible, compliant adoption of AI and digital tools, maintaining data integrity, confidentiality, and appropriate controls and documentation.
EDUCATION
- Bachelor’s degree required; an advanced degree (e.g., MBA, PharmD, PhD, MS, or equivalent) is preferred.
- Familiarity with oncology, hematology, or cell therapy is valued; scientific literacy is an asset given the nature of Medical Affairs work.
EXPERIENCE
- 8+ years of experience in Medical Affairs operations, medical excellence, business operations, or a comparable operations/program management function in the pharmaceutical or biotechnology industry.
- Demonstrated experience operating the core machinery of Medical Affairs — congresses, advisory boards, MRC/review, field support, budgets, and KPIs.
- Demonstrated, hands-on adoption of AI tools in real workflows — not only sponsoring adoption, but personally building automations, dashboards, or analyses. Deep AI expertise is not required; rapid learning and practical fluency are.
- Track record of building operating processes and systems in a fast-moving, high-growth environment with limited infrastructure; launch or launch-preparation experience is 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 — able to move fluidly between designing an operating model and building it.
- 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 for the broader team.
- Self-directed operator who identifies problems and proposes solutions without prompting, scoping and launching initiatives with minimal oversight.
- Exceptional collaboration and influence; operates credibly 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.