Director - Clinical Research Scientist-Clinical Development
Eli Lilly and Company
6 months ago
Remote friendly (Indianapolis, IN)
United States
Clinical Research and Development
Position Summary
The Clinical Research Scientist (CRS), Clinical Development, provides scientific and clinical expertise to drive evidence generation and clinical strategy across Phase 1–3 programs. Leads trial design and execution in close partnership with regulatory, statistics, NPP, medical affairs, and translational teams to deliver patient-focused outcomes.
Key Responsibilities
- Trial Design & Protocol Leadership: Lead design and authoring of Phase 1–3 protocols with cross-functional input; ensure alignment of trial design (1°/2° endpoints, SOA, imaging, population, line of therapy, biomarker incorporation) with program goals across partners (regulatory, stats, NPP, medical affairs, CMC, translational); support scientific advisory boards and steering committee meetings.
- Enrollment & Execution: Design and execute enrollment plans including country and site selection, PI identification, and risk mitigation/trend monitoring.
- Medical Affairs & External Engagement: Partner with Medical Affairs and NPP to support TPP and indication deliverables; proactively engage MSL teams for key insights and deliverables; primary author for clinical content development for regulatory submissions and meetings.
- Data & Scientific Strategy: Author (with MW) disclosures; define and monitor success metrics; synthesize external data to inform trial design and strategy; primary owner/author in data presentation at internal governance meetings and support external presentations.
Basic Qualifications
- Doctoral or advanced clinical/nursing degree (PhD, PharmD, MD, DVM, MSN with advanced clinical specialty, or equivalent) plus minimum 10 years combined clinical and/or pharmaceutical industry experience (preferably within clinical development).
- OR BS/MS in a health or scientific discipline plus minimum 15 years experience directly related to Clinical/Drug Development (e.g., pharmacology, epidemiology, toxicology, regulatory affairs).
Additional Preferences
- Experience supporting Phase I–III clinical programs; strong understanding of medical governance and regulatory requirements; ability to communicate complex scientific data; proven cross-functional collaboration and stakeholder engagement skills.
Benefits (if eligible)
- Company bonus (depending on company and individual performance); 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits (e.g., flexible spending accounts); life insurance; certain time off/leave; well-being benefits (e.g., employee assistance, fitness, employee clubs/activities).
Application/Qualifications Notes
- Must meet minimum qualifications in the posting and have/obtain work authorization in the country where the role is located. Internal applicants: current supervisor is notified.
The Clinical Research Scientist (CRS), Clinical Development, provides scientific and clinical expertise to drive evidence generation and clinical strategy across Phase 1–3 programs. Leads trial design and execution in close partnership with regulatory, statistics, NPP, medical affairs, and translational teams to deliver patient-focused outcomes.
Key Responsibilities
- Trial Design & Protocol Leadership: Lead design and authoring of Phase 1–3 protocols with cross-functional input; ensure alignment of trial design (1°/2° endpoints, SOA, imaging, population, line of therapy, biomarker incorporation) with program goals across partners (regulatory, stats, NPP, medical affairs, CMC, translational); support scientific advisory boards and steering committee meetings.
- Enrollment & Execution: Design and execute enrollment plans including country and site selection, PI identification, and risk mitigation/trend monitoring.
- Medical Affairs & External Engagement: Partner with Medical Affairs and NPP to support TPP and indication deliverables; proactively engage MSL teams for key insights and deliverables; primary author for clinical content development for regulatory submissions and meetings.
- Data & Scientific Strategy: Author (with MW) disclosures; define and monitor success metrics; synthesize external data to inform trial design and strategy; primary owner/author in data presentation at internal governance meetings and support external presentations.
Basic Qualifications
- Doctoral or advanced clinical/nursing degree (PhD, PharmD, MD, DVM, MSN with advanced clinical specialty, or equivalent) plus minimum 10 years combined clinical and/or pharmaceutical industry experience (preferably within clinical development).
- OR BS/MS in a health or scientific discipline plus minimum 15 years experience directly related to Clinical/Drug Development (e.g., pharmacology, epidemiology, toxicology, regulatory affairs).
Additional Preferences
- Experience supporting Phase I–III clinical programs; strong understanding of medical governance and regulatory requirements; ability to communicate complex scientific data; proven cross-functional collaboration and stakeholder engagement skills.
Benefits (if eligible)
- Company bonus (depending on company and individual performance); 401(k), pension, vacation; medical/dental/vision/prescription; flexible benefits (e.g., flexible spending accounts); life insurance; certain time off/leave; well-being benefits (e.g., employee assistance, fitness, employee clubs/activities).
Application/Qualifications Notes
- Must meet minimum qualifications in the posting and have/obtain work authorization in the country where the role is located. Internal applicants: current supervisor is notified.