Director - Clinical Research Scientist
Eli Lilly and Company
2 months ago
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Responsibilities:
- Lead global early-phase clinical development strategy and plans for gene-editing cardiovascular therapies.
- Provide scientific leadership for PK/PD modeling and trial stimulation to guide program decisions.
- Develop and coordinate Phase lb and Ila/IIb clinical studies; write clinical trial protocols.
- Oversee worldwide trial execution with accountability for quality and timelines; manage risk profiles and informed consent documents.
- Implement clinical biomarker strategy; review and interpret emerging trial data (biomarkers, clinical pharmacology, safety) to inform decisions.
- Partner with the medical monitor on safety reviews and site interactions; lead cross-functional decision-making meetings and mitigation plans.
- Support study start-up, training, and serve as a resource to monitors, investigators, and ethical review boards.
- Support scientific dissemination (advisory boards, abstracts, publications) and congress engagement.
- Support/direct regulatory report preparation (e.g., IND medical sections, Investigator Brochure, FDA advisory committee hearing prep) and resolve regulatory issues.
Qualifications (Basic Requirements):
- Bachelor’s degree in health/medical/scientific field plus 12+ years pharmaceutical experience in areas such as drug/clinical development, epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs.
Preferred/Additional Skills:
- 7+ years clinical experience with an advanced degree (e.g., Pharmacology, Physiology, Microbiology) OR graduate degree (DVM/PharmD/PhD/MSN with advanced clinical specialty) plus:
- Experience leading complex clinical programs and influencing regulatory strategy.
- Senior leadership/governance effectiveness; cross-functional influencing.
- Strong clinical trial design, regulatory requirements, and GCP knowledge.
- Strong problem-solving, prioritization, and data interpretation (safety/efficacy endpoints).
- Excellent communication/presentation; experience with KOLs, investigators, and CROs.
- Translational biomarker strategy experience is a plus.
Additional Information:
- Travel 10–15%.
- Eligible for company bonus and comprehensive benefits (e.g., 401(k), pension, vacation, medical/dental/vision, life insurance, time off/leave, well-being).
- Lead global early-phase clinical development strategy and plans for gene-editing cardiovascular therapies.
- Provide scientific leadership for PK/PD modeling and trial stimulation to guide program decisions.
- Develop and coordinate Phase lb and Ila/IIb clinical studies; write clinical trial protocols.
- Oversee worldwide trial execution with accountability for quality and timelines; manage risk profiles and informed consent documents.
- Implement clinical biomarker strategy; review and interpret emerging trial data (biomarkers, clinical pharmacology, safety) to inform decisions.
- Partner with the medical monitor on safety reviews and site interactions; lead cross-functional decision-making meetings and mitigation plans.
- Support study start-up, training, and serve as a resource to monitors, investigators, and ethical review boards.
- Support scientific dissemination (advisory boards, abstracts, publications) and congress engagement.
- Support/direct regulatory report preparation (e.g., IND medical sections, Investigator Brochure, FDA advisory committee hearing prep) and resolve regulatory issues.
Qualifications (Basic Requirements):
- Bachelor’s degree in health/medical/scientific field plus 12+ years pharmaceutical experience in areas such as drug/clinical development, epidemiology, toxicology, pharmacology, regulatory affairs, or medical affairs.
Preferred/Additional Skills:
- 7+ years clinical experience with an advanced degree (e.g., Pharmacology, Physiology, Microbiology) OR graduate degree (DVM/PharmD/PhD/MSN with advanced clinical specialty) plus:
- Experience leading complex clinical programs and influencing regulatory strategy.
- Senior leadership/governance effectiveness; cross-functional influencing.
- Strong clinical trial design, regulatory requirements, and GCP knowledge.
- Strong problem-solving, prioritization, and data interpretation (safety/efficacy endpoints).
- Excellent communication/presentation; experience with KOLs, investigators, and CROs.
- Translational biomarker strategy experience is a plus.
Additional Information:
- Travel 10–15%.
- Eligible for company bonus and comprehensive benefits (e.g., 401(k), pension, vacation, medical/dental/vision, life insurance, time off/leave, well-being).