Associate Vice President Global & US Medical Affairs Immunology

About the role

At Lilly, we unite caring with discovery to create medicines that make life better for people around the world. This role provides leadership, supervision, coordination, mentoring, career development, and performance management for all activities and individuals within the Global Medical Affairs – Immunology (Rheumatology, Respiratory & Pipeline) team. The Associate VP has review and approval authority for grants, contracts, label changes, protocols, informed consent documents, and other key documents. This position drives strategic planning, oversees clinical research, and ensures alignment with global Medical Affairs, brand, and Development teams. The role maintains compliance with regulations, laws, and company policies while fostering collaboration across global and affiliate teams.

Responsibilities

• Career Development and Performance Management:
  • Develop performance and career plans for direct reports, ensuring documentation of expertise and progress.
  • Coach, mentor, and evaluate direct reports, maximizing their career potential and organizational value.
  • Conduct capacity planning, work allocation, and talent retention for long-term success.
  • Present direct reports’ achievements to leadership, HR, and Global Medical Capabilities for talent assessment and promotion.
  • Participate in succession planning and recognize exceptional performance.
  • Ensure direct reports are qualified, trained, and compliant with curriculum training requirements.
• Oversight of Clinical Planning, Budgeting, and Execution:
  • Provide affiliate input into clinical planning across the asset lifecycle (Phase 1/2 through Phase 4).
  • Align clinical programs with patient, prescriber, and payer needs in global and US markets.
  • Lead local/regional clinical planning, ensuring alignment with brand, affiliate, and company strategies.
  • Ensure clinical plans are coherent and non-conflicting with Early Phase, Program Phase, and global Development teams.
  • Monitor progress toward clinical research commitments and take corrective actions as needed.
  • Oversee implementation of medical team deliverables (e.g., publications, field support).
  • Generate, approve, and implement local support for clinical research within budgetary constraints.
  • Monitor operational expenses and address deviations from approved budgets.
• Medical Affairs Shift-Left Contribution for Pipeline Assets:
  • Drive Medical Affairs plans for therapeutic areas, including Phase 1/2 molecules.
  • Partner with Research, Early Phase Clinical Pharmacology, Translational Medicine, and Program Phase teams to shape target product profiles, clinical development plans, and evidence strategy.
  • Coordinate with Development, Marketing, IR teams, and other therapeutic areas for seamless transitions from pipeline to launch.
  • Accountable for Medical Affairs Integrated Evidence Generation (IEG) plans, Integrated Roadmap (IR), and Cross-functional Clinical Governance (CCG) forums.
• Deep Scientific and Technical Expertise:
  • Maintain deep scientific and technical expertise in the therapeutic area.
  • Serve as a role model and functional member of research, submission, registration, and commercialization teams.
  • Stay updated on pre-clinical, clinical pharmacology, and clinical data relevant to the team’s molecules.
  • Critically evaluate medical literature, competitive product data, and scientific developments.
  • Review and approve Investigator-Initiated Trial (IIT) proposals and publications.
• Scientific Data Dissemination and Exchange:
  • Oversee timely dissemination of clinical trial data.
  • Ensure critical analysis and dissemination of data via manuscripts, abstracts, posters, and slide sets.
  • Plan symposia, advisory board meetings, and other engagements with healthcare professionals.
  • Support scientific congresses, including presentations, booth staffing, and thought leader interactions.
• Business and Customer Support (Pre- and Post-Launch):
  • Ensure medical teams are trained and compliant with standards for customer interactions.
  • Provide scientific support for marketing and sales activities.
  • Partner internally and externally (e.g., alliances, joint ventures) to advance business goals.
  • Contribute to medical strategies supporting brand commercialization, working with brand teams, Global Patient Outcomes, and PRA.
  • Provide clinical input for payer partnership programs and product value defense.
  • Lead strategic planning for the brand and define the Patient Journey and Moments of Truth.
  • Serve as a patient advocate and medical expert.
• Regulatory and Submission Responsibilities:
  • Ensure clinical data for regulatory purposes meets all necessary standards.
  • Support global registrations, labeling, and resolution of regulatory issues.
  • Participate in or oversee Advisory Committee(s).
  • Escalate drug safety and device issues to Global Patient Safety.
• Administrative Responsibilities:
  • Review and approve major business documents (e.g., research protocols, contracts, informed consent forms, label changes, travel expenses).
  • Serve as a member of the local/regional management team, contributing to policy development and strategic planning.
  • Represent the business unit in management meetings and as an active leader in the organization.
  • Participate in projects, committees, task forces, and other initiatives as requested.