Role Summary
Senior/Executive Director, Global Medical Affairs (Cardiovascular/Cardiometabolic Health) responsible for strategic medical planning and execution across launch and commercialization activities, including clinical trials oversight, regulatory and PRA support, and scientific data dissemination. Serves as a scientific resource for study teams and ensures compliance with relevant regulations and standards.
Responsibilities
- Provide expert medical support to local/global business, including patient journey development and strategic planning for the compound.
- Provide medical support for regulatory affairs and interactions with government agencies; support New/Subsequent New Drug submissions and meetings.
- Offer medical guidance on pricing, reimbursement, and access plans; interact with PRA agencies as needed.
- Lead scientific data dissemination, present at conferences/advisory boards, and oversee educational program content.
- Plan, startup, and conduct phase 3b/4 studies; expand real-world evidence and patient-reported outcomes to address commercial needs.
- Support pre- and post-launch activities, including symposia planning, advisory boards, medical information materials, and training of medical personnel.
- Prepare/science material responses to customer questions or media inquiries; provide congress support and participate in data analyses and publications.
- Establish collaborations with external experts and professional societies; design customer research as a medical expert; assist in Clinical Trial Registry reporting.
- Collaborate with CRSs, regional ops, statisticians, health outcomes, and investigators to develop protocols and data collection requirements.
- Ensure administrative requirements for study initiation/conduct are documented; train investigators and site personnel; support safety monitoring and AE follow-up.
- Stay aware of therapeutic area trends; critically review literature; train clinical study teams; act as scientific consultant and protocol expert.
- Attend and contribute to medical congresses and scientific symposia.
- Act as ambassador for patients and Lilly Brand; balance scientific and business priorities; demonstrate strong leadership and communication skills.
Qualifications
- Medical Doctor or Doctor of Osteopathy; board eligible or certified in appropriate specialty/subspecialty; US-trained physicians must be board eligible/certified.
- Minimum 2 years of clinical experience in cardiovascular medicine.
Preferences
- Cardiology board eligible or certified preferred.
- Prior pharmaceutical industry experience in medical affairs or clinical development preferred.
- Knowledge of drug development process preferred.
- Ability to balance scientific and business priorities; strong influencing, leadership, and communication skills.
- Ability to travel domestically and internationally as needed.
- Fluent in English, verbal and written.
Skills
- Deep understanding of cardiovascular pathophysiology and clinical management.
- Medical planning for launch, data dissemination, and real-world evidence generation.
- Experience with regulatory communications and PRA interactions.
- Scientific writing, presentation, and stakeholder engagement across multiple levels.