Executive Medical Director, CardioRenal

About the Role

At Lilly, we unite caring with discovery to help make life better for people around the world. This role is part of a team working on complex challenges to discover and deliver life-changing medicines, with a focus on expanding our cardio-renal portfolio. The Executive Director will report to the Senior Vice President of Cardio-Renal Research and Early Clinical Development and will provide clinical development leadership, leveraging scientific expertise in cardiovascular diseases (with renal diseases as a bonus).

Responsibilities

• Clinical Planning
  • Collaborate with Preclinical groups, Clinical Pharmacology, Health Outcomes, and New Product Planning to develop and maintain Draft Launch Labels and Value Propositions addressing key customer needs (patient, provider, and payer).
  • Contribute to global alignment of clinical strategy and plans with business unit and Lilly Research Laboratories (LRL) priorities.
  • Stay updated on pre-clinical and clinical data relevant to molecules.
  • Represent Lilly in external forums discussing standards, protocols, assessment instruments, regulatory standards, and clinical guidelines for drug development.
• Clinical Research/Trial Execution and Support
  • Collaborate with clinical research staff on trial design, conduct, and reporting (e.g., sample size, patient commitment, timelines, grants, and governance reviews).
  • Review and approve risk profiles to ensure appropriate communication of risk to study subjects.
  • Participate in investigator identification and selection alongside clinical teams.
  • Ensure operational teams document administrative requirements for study initiation and conduct (e.g., ethical review board approvals, informed consent, regulatory notifications) consistent with Good Clinical Practices (GCPs) and local laws.
  • Assist in study start-up meetings and provide training to investigators and site personnel.
  • Serve as a resource for clinical operations personnel, monitors, investigators, and ethical review boards to address questions or issues during studies.
  • Monitor patient safety during studies and track/follow up on adverse events in alignment with corporate patient safety policies.
• Scientific Data Dissemination/Exchange
  • Comply with local laws, global policies, and compliance guidelines for data dissemination and interactions with external healthcare professionals.
  • Stay updated on clinical research methodology, including biomarkers, efficacy measures, diagnostic practices, study designs, safety evaluations, and regulatory standards.
  • Address unsolicited scientific information needs of external healthcare professionals.
  • Participate in Clinical Trial Registry activities and reporting of clinical trial data.
  • Support planning for symposia, advisory board meetings, and other engagements with healthcare professionals.
  • Prepare or review scientific information for investigator questions or media requests.
  • Support data analysis and development of slide sets, publications (abstracts, posters, manuscripts), and final reports.
  • Establish and maintain collaborations with external experts, thought leaders, and professional societies.
  • Support customer research design as a medical expert in collaboration with New Product Planning.
  • Train medical personnel, including geographic/affiliate CRPs, medical liaisons, and health outcomes personnel.
  • Provide technical support for due diligence activities.
• Regulatory Support Activities
  • Participate in the development and review of global regulatory documents in collaboration with affiliates, regulatory, and legal teams.
  • Provide medical expertise to regulatory scientists.
  • Support preparation of regulatory reports (e.g., INDs, FDA annual reports, regulatory responses, Periodic Adverse Drug Experience Reports).
  • Participate in face-to-face meetings with regulatory bodies (e.g., FDA, EMEA) to advance clinical development.
  • Engage in risk management planning with affiliates and Global Patient Safety (GPS).
• Business/Customer Support (Pre- and Post-Launch)
  • Contribute to medical strategies supporting brand commercialization by collaborating with business units, New Product Planning, and business development.
  • Understand and address the scientific information needs of development customers (payers, patients, healthcare providers).
  • Lead data analyses and new clinical or health outcomes research to address customer questions.
  • Establish collaborations with New Product Planning and Health Outcomes to support corporate demand realization.
  • Maintain contact with external experts and opinion leaders to facilitate scientific and medical engagements.
  • Contribute as a scientific and medical expert to PRA (pricing, reimbursement, and access) activities, including compound valuations.
  • Review and support New Product Planning, technical probability assessments, and valuation activities.
  • Familiarize with market archetypes and their influence on medical interventions for the product.
  • Participate in payer, commercialization, and regulatory advisory boards.
• Scientific/Technical Expertise and Continued Development
  • Critically evaluate relevant medical literature and stay updated on competitive molecules in development.
  • Maintain and disseminate information on developments in pathophysiology, diagnosis, etiology, treatment, and management of disease states for supported molecules.
  • Stay aware of trends and projections for clinical practice and access in relevant therapeutic areas.
  • Explore opportunities for extramural scientific experiences.
• General Responsibilities
  • Support the management team in preparing and administering the development budget.
  • Set and meet individual professional development goals and contribute to the development of others through coaching and feedback.
  • Ensure compliance with training requirements and maintain a current curriculum training map.
  • Model effective leadership behaviors and serve as an ambassador for the Lilly brand.

Requirements

• Medical Doctor (MD) or Doctor of Osteopathy (DO).
• Must be board-eligible or certified in a relevant field or have completed comparable post-medical school clinical training.
• US-trained physicians must have achieved board eligibility or certification.
• Non-US trained physicians must have completed education and training at a medical school meeting Liaison Committee on Medical Education (LCME) requirements.
• Five years of experience in clinical research/drug development in academia or industry, including design and implementation of large global clinical trials.

Skills

• Board certification in cardiovascular diseases (renal diseases is a bonus).
• Clinical trialist with a track record of developing clinical plans and executing studies in the pharmaceutical industry.
• Demonstrated capacity to lead and manage groups of professionals.
• Strong administrative and teamwork skills.
• Ability to work within Lilly’s governance structure.
• Awareness of and compliance with local/international regulations, laws, guidance (e.g., FDA, ICH, CPMP), GCPs, company standards, and Lilly policies.