Executive Director, Global Oncology Medical Affairs, Evidence Generation

Vacancy NameExecutive Director, Global Oncology Medical Affairs, Evidence Generation Vacancy NoVN852 Employment TypeFull Time Location of roleGaithersburg, MD, Radnor, PA DepartmentMedical Affairs - US Key ResponsibilitiesMain Purpose of Job:

The Executive Director, Global Oncology Medical Affairs, Evidence Generation role is responsible for leading a cross-functional Evidence Generation matrix team and developing an Integrated Evidence Plan (IEP)

Key Responsibilities:

Data Generation

• Leads the data gap analysis and development of an Integrated Evidence Plan (IEP) with close collaboration with the respective Research and Development team(s), Global Product Team (GPT), Medical Affairs market leads, and other internal and external stakeholders. Provides thought leadership as to evidence gaps and priorities for the various programs.
• Work collaboratively with the global product team and participate in the clinical and scientific communication sub teams as an integral member, to develop a robust strategic evidence generation plan that complements the Clinical Development plan and registrational studies.
• Responsible for execution of the IEP as it pertains to non-registrational data generation(NRDG) including sponsored NRDG trials, externally sponsored research (ESRs), collaborative research, and non-interventional and real world evidence generation.
• Leads process for identification of data gaps, areas of interest (AOIs), and requests for proposals (RFPs) and leads the review and prioritization process (in collaboration with appropriate cross-functional parters) and ensures governance approvals, contracting, and budgeting.
• Ensures approved ESRs maintain appropriate timelines/meet expected milestones by on-going engagement with study sites, investigators, and research networks.
• Ensure, in collaboration with the Global Medicines Lead, Program Lead, and Clinical Development, alignment of IEPs across the portfolio, with an emphasis on late stage clinical through commercial programs, including life cycle management.
• Lead identification of Externally Sponsored Research (ESR) areas of interest in partnership with Health Economics Research (HEOR) and Translational Research.
• Works collaboratively with Market Access/HEOR in developing real world data strategic and publication plans as part of the IEPs for the assigned products/tumors.
• Leads the Registry Data generation activities and partnership (e.g., Pulse OMNI registry, collaborations with other global registries)
• Collaborates closely with Insights & Analytics, Market Access, and HEOR to address real world evidence (RWE) and HEOR opportunities identified in or to evolve the IEP
• Oversees excellence in execution of clinical ESR program, ensuring trials meet their milestones and if execution issues are identified, that the investigator(s) provide appropriate mitigation plans to address delays. maintains awareness of execution for non-clinical ESRs, working closely with the TM team to address any identified issues.
• Ensures budgets, timelines, and compliance requirements are appropriate and factored into IEP and data delivery expectations.
• Accountable for ESR and registry budget
• Accountable for maintenance of appropriate SOPs, policies, and work instructions

Non-registrational Sponsored Trials (NRDG)

• Establish a Medical Affairs capability for non-registrational sponsored trials e.g.phase IV to generate RWE and inform clinical practice encompassing the following responsibilities:
• Strategic Planning: Identify and prioritize trial concepts for internal sponsorship in collaboration with cross-functional product teams.
• Study Design: Lead the clinical design of sponsored studies, partnering with Clinical Development Leads to ensure scientific rigor and asset alignment
• Operation Oversight: Direct study execution from initiation through to data readout, ensuring excellence in operational delivery and compliance
• Scientific Communications: Collaborate with the Scientific Communication subteam to develop and execute comprehensive study publication plans
• Will be required to identify (in conjunction with the appropriate product team members) which trial concepts should be conducted as sponsored trials, design the trial (collaborating with the Clinical Development Lead for the tumor/asset), and ensure excellence in execution of the study through to completion.
• Will collaborate with the Scientific Communication Subteam regarding study publication planning.
• Develop processes, policies, SOPs, and work instructions as required for a NRDG program
• Work collaboratively with Clinical Ops to develop the capability to support NRDG studies operationally. Provide senior leadership with appropriate updates on both strategic drivers and study execution.

External Collaborations

• Accountable for development of strategic partnerships with cooperative groups and other research networks and organizations (EORTC, SARC, CTEP, COG, MRA, Sarah Cannon, etc), developing a robust relationship and engagement plan while optimizing opportunities for collaboration. Facilitates strong relationships between external thought leaders (and/or cooperative groups) and the product teams to ensure strategic alignment.
• Participate in business development activities on an as-needed basis

Supervisory Responsibility (If applicable):

• Assistant Director, ESR Clinical Operations
• There may be additional FTE and vendor management as designated

Education, Experience and Knowledge:

• Advanced Clinical/Science Degree (e.g., MD, PhD, PharmD)
• At least 5 plus years of experience in the pharmaceutical field or alliance / partnership experience with External Experts
• Oncology experience, with experience in melanoma preferred
• Experience developing global or regional medical data generation strategy
• IEP development experience
• Experience planning and conducting interventional and non-interventional studies, including Ph 3b/4, EAP, externally sponsored research programs, external clinical collaborations, and observational studies required
• Enterprise thinking and the ability to leverage synergies across products/compounds/disease areas
• Demonstrated leadership and collaboration skills with a proven ability to build and maintain relationships with diverse groups of people and audiences.
• Ability to foster strong, compliant, productive, and value-added alliances.
• Proven ability to establish and evolve relationships with scientific societies, other influential organizations, and external experts to advance science to meet the challenges in healthcare.
• Ability to work in a highly matrixed environment with ability to manage multiple projects and collaborate with many cross functional stakeholders.
• Critical to have very strong interpersonal, public communication, and negotiation skills.
• Knowledge of the drug development process and commercialization
• Strong project management skills and substantive 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 and a self-starter
• 25% travel required based on needs of the position About the CompanyImmunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry's most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering the big questions.

Focused on delivering first-in-class biological therapies to patients, we have developed a 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, including oncology, infectious diseases and autoimmune diseases.

At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients' lives, advancing medicine, and supporting one another in these pursuits.

Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.