Role Summary
Executive Medical Director - Cardio-Renal. Lead clinical development for Lilly's cardio-renal portfolio, providing strategic direction across all phases of development and coordinating with preclinical teams, regulatory bodies, and external experts.
Responsibilities
- Clinical Planning: Develop and maintain clinical strategies, launch labels, and value propositions aligned with molecule biology and development plans; ensure global alignment with priorities.
- Clinical Research/Trial Execution and Support: Design, conduct, and oversee local/global clinical trials; assess risk profiles; manage investigator identification and site activation; ensure compliance with GCPs and regulatory requirements; ensure patient safety and AE reporting.
- Scientific Data Dissemination/Exchange: Ensure compliance with data dissemination guidelines; oversee scientific communications, publications, and external engagements; foster collaborations with experts and professional societies; support training and due diligence activities.
- Regulatory Support Activities: Develop and review regulatory documents; provide medical input to regulators; participate in regulatory meetings; support risk management with GPS.
- Business/Customer Support: Contribute to medical strategies for brand commercialization; address information needs of payers, patients, and providers; collaborate with New Product Planning and Health Outcomes; engage external experts and advisory boards.
- Scientific / Technical Expertise and Continued Development: Stay current with literature and advancements; communicate developments within Lilly; explore extramural opportunities.
- General Responsibilities: Support development budget, professional development, governance, leadership, and brand representation.
Qualifications
- Medical Doctor or Doctor of Osteopathy; board-eligible or board-certified in appropriate specialty/subspecialty; US-trained physicians must be board eligible/certified. Non-US physicians must meet LCME standards.
- Five years of experience in clinical research/drug development, including design/implementation of large global trials.
Additional Skills/Preferences
- Business acumen is a plus
- Five years of clinical practice with at least 2 years in cardiovascular or renal medicine
- Legal authorization to work in the United States; sponsorship not provided
- Demonstrated leadership and administrative skills; strong communication and negotiation abilities