Executive Medical Director - Cardio-Renal

Role Summary

Executive Medical Director - Cardio-Renal is a leadership role focused on providing clinical development leadership for Lilly’s cardio-renal portfolio, guiding strategies and trials across all development phases, and interfacing with regulatory bodies and external experts.

Responsibilities

• Clinical Planning: Develop and maintain draft launch labels and value propositions; align clinical strategy with business priorities; stay updated with relevant data; represent Lilly in external standards and guidelines discussions.
• Clinical Research/Trial Execution and Support: Design, conduct, and report local clinical trials; assess and communicate risk; participate in investigator identification; ensure trial initiation and conduct meet GCPs and local requirements; train investigators and site personnel; provide ongoing support to clinical operations; monitor safety and adverse events.
• Scientific Data Dissemination/Exchange: Ensure compliance with data dissemination guidelines; understand clinical research methodologies; address external information needs; report trial data in registries; plan symposia and meetings; prepare scientific responses; support publications and collaborations with external experts and societies; support training and due diligence; prepare final reports.
• Regulatory Support Activities: Develop and review regulatory documents; provide medical expertise to regulatory scientists; assist in regulatory reports and FDA interactions; engage with regulatory bodies as needed; participate in risk management planning with affiliates and GPS.
• Business/Customer Support: Develop medical strategies to support brand commercialization; address information needs of development customers; respond to payer, patient, and provider questions; collaborate with New Product Planning and Health Outcomes; engage external experts and thought leaders; contribute to pricing, reimbursement, and access activities; support payer and advisory boards.
• Scientific/Technical Expertise and Development: Stay current with medical literature and developments; maintain knowledge of disease pathophysiology and treatments; monitor trends in clinical practice; pursue extramural scientific opportunities.
• General Responsibilities: Support development budget management; pursue professional development; maintain qualifications and training; model leadership; act as Lilly brand ambassador.

Qualifications

• Medical Doctor or Doctor of Osteopathy; board eligible or certified in appropriate specialty/subspecialty; US board eligibility/certification required for US-trained physicians; non-US trained physicians must meet LCME requirements.
• Five years of experience in clinical research/drug development, including design and implementation of large global trials or equivalent.

Additional Skills/Preferences

• Business acumen is a plus
• Five years of clinical practice with at least 2 years in cardiovascular or renal medicine is preferred
• Authorized to work in the United States; sponsorship for visa status is not anticipated
• Demonstrated leadership, administrative, teamwork, and governance skills
• Strong communication, interpersonal, and negotiation skills