Executive Medical Director, CardioRenal

About the Role

At Lilly, we unite caring with discovery to help make life better for people around the world. Our over 50,000 employees tackle complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This role is critical in advancing our cardio-renal portfolio, building on Lilly’s heritage in diabetes care and expanding into cardiovascular and renal diseases.

The Executive Director will report to the Senior Vice President of Cardio-Renal Research and Early Clinical Development, providing clinical development leadership for a rapidly expanding portfolio. This position requires broad scientific expertise in cardiovascular diseases, with additional experience in 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).
  • Ensure 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 and represent Lilly in external forums on drug development standards, protocols, and regulatory guidelines.
• 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, ensuring compliance with Good Clinical Practices (GCPs) and local laws.
  • Assist in study start-up meetings and training for investigators and site personnel.
  • Serve as a resource for clinical operations, monitors, investigators, and ethical review boards during study conduct.
  • Monitor patient safety, track adverse events, and ensure alignment with corporate patient safety policies.
• Scientific Data Dissemination/Exchange:
  • Ensure compliance with local laws, global policies, and guidelines for data dissemination and interactions with external healthcare professionals.
  • Address unsolicited scientific information needs of external healthcare professionals.
  • Participate in Clinical Trial Registry activities and support data reporting.
  • Plan and support symposia, advisory board meetings, and other engagements with healthcare professionals.
  • Prepare or review scientific information for investigator questions or media requests.
  • Support data analysis, slide set development, and publications (abstracts, posters, manuscripts).
  • Establish and maintain collaborations with external experts, thought leaders, and professional societies.
  • Support customer research design and training for medical 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 and assist in preparing regulatory reports (e.g., INDs, FDA annual reports, PADERS).
  • Engage in face-to-face meetings with regulatory bodies (e.g., FDA, EMEA) and support risk management planning.
• Business/Customer Support (Pre- and Post-Launch):
  • Contribute to medical strategies supporting brand commercialization in collaboration with business units and New Product Planning.
  • Understand and address the scientific information needs of development customers (payers, patients, healthcare providers).
  • Establish collaborations with New Product Planning and Health Outcomes to advance corporate demand realization.
  • Maintain contact with external experts and opinion leaders to facilitate scientific and medical engagements.
  • Provide clinical input for pricing, reimbursement, and access (PRA) activities, including compound valuations.
  • Support New Product Planning in technical probability assessments and valuation activities.
  • 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 and scientific developments.
  • Maintain and disseminate information on disease pathophysiology, diagnosis, treatment, and management for supported molecules.
  • Stay informed about clinical practice trends and access projections in relevant therapeutic areas.
  • Pursue extramural scientific experiences and opportunities for professional growth.
• General Responsibilities:
  • Support the management team in preparing and administering the development budget.
  • Set and meet individual professional development goals and provide coaching and feedback to co-workers.
  • 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.

Qualifications

• 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, including the design and implementation of large global clinical trials.

Skills

• Board certification in cardiovascular diseases (renal diseases is a bonus).
• Proven track record as a clinical trialist in the pharmaceutical industry, with experience developing clinical plans and executing studies.
• Demonstrated leadership and management skills for groups of professionals.
• Strong administrative and teamwork skills.
• Ability to work within Lilly’s governance structure.