Director, Medical Affairs Operations
Lyell Immunopharma · United States · 5 days ago
RemoteRemoteResearch$230k–$280k/yrFull-time
Key Role and Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
- Serve as the operational connective tissue between Medical Affairs and the rest of the organization — Clinical Development, Clinical Operations, Regulatory, Commercial, and Legal.
- Coverage of launch-readiness workstreams in partnership with cross-functional teams.
- 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.
Salary Range
- The salary range for this position is $230,000 to $280,000, annually, with the opportunity to earn an annual bonus.
- Employees are also eligible to participate in Lyell’s Equity Incentive Plan.
About the Company
- Lyell is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies.
- We are founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer.
- We are a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients.
- We have a culture based on Science, Respect, Collaboration, and Courage.