Executive Medical Director
Eli Lilly and Company
1 month ago
Remote friendly (Boston, MA)
United States
Medical Affairs
Purpose: Provide clinical development leadership for Lilly’s cardio-renal portfolio for cardiometabolic and renal diseases.
Responsibilities:
- Lead clinical planning and align global clinical strategy/plans; maintain launch labels/value propositions.
- Work with preclinical teams to progress molecules to first-in-human; develop clinical development strategies and trials across phases.
- Design, conduct, report, and support local/global clinical trials; ensure study initiation requirements (IRB/ethics, informed consent, regulatory approvals/notifications) and GCP compliance.
- Approve risk profiles; select investigators; monitor patient safety and track/report adverse events.
- Disseminate scientific data; support publications/abstracts/posters; plan symposia/advisory boards; support training and external expert collaborations.
- Provide regulatory support (INDs, annual reports, regulatory responses, PADREPs); participate in regulator meetings; support risk management.
- Support commercialization/customer needs (payer/patient/provider) with data analyses and clinical/health outcomes research; provide input to pricing/reimbursement/access.
- Maintain up-to-date medical literature and therapeutic-area knowledge.
- Support budget/professional development, coaching, leadership, and training compliance.
Qualifications (Basic):
- MD board eligible/certified in Nephrology (or comparable post-medical training). Non-U.S. training must meet LCME requirements.
Skills/Preferences:
- 5+ years clinical research/drug development (academia/industry), including large global trials.
- Track record as a clinical trialist developing clinical plans/executing studies.
- Experience in clinical practice with at least 2 years in renal disease; demonstrated leadership/administrative and communication skills.
Benefits (explicitly stated):
- Eligibility for 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits.
- Company bonus eligibility (performance-based).
Responsibilities:
- Lead clinical planning and align global clinical strategy/plans; maintain launch labels/value propositions.
- Work with preclinical teams to progress molecules to first-in-human; develop clinical development strategies and trials across phases.
- Design, conduct, report, and support local/global clinical trials; ensure study initiation requirements (IRB/ethics, informed consent, regulatory approvals/notifications) and GCP compliance.
- Approve risk profiles; select investigators; monitor patient safety and track/report adverse events.
- Disseminate scientific data; support publications/abstracts/posters; plan symposia/advisory boards; support training and external expert collaborations.
- Provide regulatory support (INDs, annual reports, regulatory responses, PADREPs); participate in regulator meetings; support risk management.
- Support commercialization/customer needs (payer/patient/provider) with data analyses and clinical/health outcomes research; provide input to pricing/reimbursement/access.
- Maintain up-to-date medical literature and therapeutic-area knowledge.
- Support budget/professional development, coaching, leadership, and training compliance.
Qualifications (Basic):
- MD board eligible/certified in Nephrology (or comparable post-medical training). Non-U.S. training must meet LCME requirements.
Skills/Preferences:
- 5+ years clinical research/drug development (academia/industry), including large global trials.
- Track record as a clinical trialist developing clinical plans/executing studies.
- Experience in clinical practice with at least 2 years in renal disease; demonstrated leadership/administrative and communication skills.
Benefits (explicitly stated):
- Eligibility for 401(k), pension, vacation; medical/dental/vision/prescription benefits; flexible benefits; life insurance/death benefits; time off/leave; well-being benefits.
- Company bonus eligibility (performance-based).