Executive Director, Global Oncology Medical Affairs, Evidence Generation

Location: Gaithersburg, MD or Radnor, PA

About the Role

The Executive Director, Global Oncology Medical Affairs, Evidence Generation leads a cross-functional Evidence Generation matrix team and develops an Integrated Evidence Plan (IEP).

Responsibilities

• Data Generation
  • Leads data gap analysis and development of an Integrated Evidence Plan (IEP) in collaboration with Research and Development, Global Product Team (GPT), Medical Affairs market leads, and other stakeholders.
  • Provides thought leadership on evidence gaps and priorities for various programs.
  • Collaborates with the global product team to develop a strategic evidence generation plan complementing the Clinical Development plan and registrational studies.
  • Executes the IEP for non-registrational data generation (NRDG), including sponsored NRDG trials, externally sponsored research (ESRs), collaborative research, and real-world evidence generation.
  • Leads the process for identifying data gaps, areas of interest (AOIs), and requests for proposals (RFPs), including review, prioritization, governance approvals, contracting, and budgeting.
  • Ensures ESRs maintain timelines and milestones through ongoing engagement with study sites, investigators, and research networks.
  • Aligns IEPs across the portfolio with Global Medicines Lead, Program Lead, and Clinical Development, focusing on late-stage clinical through commercial programs.
  • Identifies ESR areas of interest in partnership with Health Economics Research (HEOR) and Translational Research.
  • Collaborates with Market Access/HEOR to develop real-world data strategies and publication plans as part of IEPs.
  • Leads Registry Data generation activities and partnerships (e.g., Pulse OMNI registry, global registries).
  • Collaborates with Insights & Analytics, Market Access, and HEOR to address real-world evidence (RWE) and HEOR opportunities.
  • Oversees execution of clinical ESR programs, ensuring milestones are met and mitigation plans are in place for delays.
  • Monitors non-clinical ESR execution and addresses issues with the TM team.
  • Ensures budgets, timelines, and compliance requirements are integrated into IEP and data delivery expectations.
  • Accountable for ESR and registry budgets.
  • Maintains appropriate SOPs, policies, and work instructions.
• Non-registrational Sponsored Trials (NRDG)
  • Establishes Medical Affairs capability for non-registrational sponsored trials (e.g., Phase IV) to generate RWE and inform clinical practice.
  • Strategic Planning: Identifies and prioritizes trial concepts for internal sponsorship in collaboration with cross-functional product teams.
  • Study Design: Leads clinical design of sponsored studies, partnering with Clinical Development Leads for scientific rigor and asset alignment.
  • Operation Oversight: Directs study execution from initiation to data readout, ensuring operational excellence and compliance.
  • Scientific Communications: Collaborates with the Scientific Communication subteam to develop and execute study publication plans.
  • Develops processes, policies, SOPs, and work instructions for the NRDG program.
  • Collaborates with Clinical Ops to develop operational support for NRDG studies.
  • Provides senior leadership with updates on strategic drivers and study execution.
• External Collaborations
  • Develops strategic partnerships with cooperative groups and research networks (e.g., EORTC, SARC, CTEP, COG, MRA, Sarah Cannon).
  • Facilitates relationships between external thought leaders, cooperative groups, and product teams for strategic alignment.
  • Participates in business development activities as needed.
• Supervisory Responsibility
  • Assistant Director, ESR Clinical Operations (additional FTE and vendor management as designated).

Requirements

• Advanced Clinical/Science Degree (e.g., MD, PhD, PharmD).
• At least 5+ years of experience in the pharmaceutical field or alliance/partnership experience with external experts.
• Oncology experience, with melanoma experience preferred.
• Experience developing global or regional medical data generation strategy and IEP development.
• Experience planning and conducting interventional and non-interventional studies, including Phase 3b/4, EAP, ESR programs, external clinical collaborations, and observational studies.
• Enterprise thinking and ability to leverage synergies across products/compounds/disease areas.
• Demonstrated leadership and collaboration skills with a proven ability to build and maintain relationships across diverse groups.
• Ability to foster strong, compliant, productive, and value-added alliances.
• Proven ability to establish and evolve relationships with scientific societies, influential organizations, and external experts.
• Ability to work in a highly matrixed environment and manage multiple projects with cross-functional stakeholders.
• Strong interpersonal, public communication, and negotiation skills.
• Knowledge of the drug development process and commercialization.
• Strong project management skills and a track record in leading cross-functional teams.
• Solid understanding of the applicable regulatory environment and industry standards.
• Demonstrated technical, organizational, project management, negotiation, and budgeting capabilities.
• Self-starter with a proactive approach.

About the Company

Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company developing transformative medicines for oncology, infectious diseases, and autoimmune diseases. Our leaders in R&D are internationally recognized for successful drug development. We focus on delivering first-in-class biological therapies using our highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision-engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need.

We value our employees and embrace a culture of Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE). Immunocore is committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds.

25% travel required based on needs of the position.