Executive Medical Director
Eli Lilly and Company
1 month ago
Remote friendly (Indianapolis, IN)
United States
Medical Affairs
Purpose: Provide clinical development leadership for Lilly’s cardio-renal portfolio (renal/cardiovascular/metabolic diseases), including preclinical-to-first-in-human strategy, global trial execution, patient safety oversight, regulatory interactions, and external expert engagement.
Responsibilities:
- Collaborate on clinical planning (launch labels/value propositions; clinical strategies, development plans, protocol designs) and align clinical plans with business priorities.
- Design, conduct, report, and support local/global clinical trials; approve risk profiles; ensure start-up readiness (IRB/informed consent/regulatory); support investigator selection; monitor patient safety and adverse events.
- Disseminate/exchange scientific data (registries, congress/symposia/advisory boards, investigator/media responses, slide sets/publications) and build collaborations with external experts/professional societies.
- Support regulatory activities (global regulatory document development/review; IND/FDA reporting; risk management planning; meetings with regulators).
- Provide customer/brand support pre- and post-launch (medical strategies, payer/provider/patient questions, clinical input to pricing/reimbursement/access valuations).
- Maintain scientific expertise via literature review and knowledge dissemination.
Basic Qualifications:
- MD board eligible/certified in Nephrology (or comparable post-medical clinical training).
- Non-U.S. MDs: training at LCME-compliant medical school.
Additional Skills/Preferences:
- 5+ years clinical research/drug development (academia or industry), including large global trials.
- Clinical trialist track record; leadership/administrative ability; strong communication/interpersonal/negotiation skills.
- 5 years clinical practice with 2+ years renal disease (ideal); business acumen (ideal).
Benefits (if applicable in role section):
- Company bonus (depending on performance); 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time-off/leave benefits, well-being benefits (e.g., EAP/fitness).
Responsibilities:
- Collaborate on clinical planning (launch labels/value propositions; clinical strategies, development plans, protocol designs) and align clinical plans with business priorities.
- Design, conduct, report, and support local/global clinical trials; approve risk profiles; ensure start-up readiness (IRB/informed consent/regulatory); support investigator selection; monitor patient safety and adverse events.
- Disseminate/exchange scientific data (registries, congress/symposia/advisory boards, investigator/media responses, slide sets/publications) and build collaborations with external experts/professional societies.
- Support regulatory activities (global regulatory document development/review; IND/FDA reporting; risk management planning; meetings with regulators).
- Provide customer/brand support pre- and post-launch (medical strategies, payer/provider/patient questions, clinical input to pricing/reimbursement/access valuations).
- Maintain scientific expertise via literature review and knowledge dissemination.
Basic Qualifications:
- MD board eligible/certified in Nephrology (or comparable post-medical clinical training).
- Non-U.S. MDs: training at LCME-compliant medical school.
Additional Skills/Preferences:
- 5+ years clinical research/drug development (academia or industry), including large global trials.
- Clinical trialist track record; leadership/administrative ability; strong communication/interpersonal/negotiation skills.
- 5 years clinical practice with 2+ years renal disease (ideal); business acumen (ideal).
Benefits (if applicable in role section):
- Company bonus (depending on performance); 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time-off/leave benefits, well-being benefits (e.g., EAP/fitness).