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 part of our commitment to innovating in diabetes care, 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 cardio-renal 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.
  • 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 review).
  • 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 approvals) consistent 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 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 guidelines regarding 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 (e.g., 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 personnel to further 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 clinical input for compound valuations.
  • Review and support New Product Planning, technical probability assessments, and valuation activities.
  • Familiarize yourself 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 the latest developments in pathophysiology, diagnosis, etiology, treatment, and management of disease states relevant to supported molecules.
  • Stay aware of current 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.

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 achieve board eligibility or certification. Non-US trained physicians may be hired at the discretion of the Chief Medical Officer.
• 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 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, 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 and international regulations, laws, guidance (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, Lilly policies, and Principles of Medical Research.