[Hiring] Director - Clinical Research Scientist-Clinical Development @Eli Lilly and Company

Role Description

The Clinical Research Scientist (CRS), Clinical Development, provides scientific and clinical expertise to drive evidence generation and clinical strategy across Phase 1–3 programs. This role 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 functional 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; ensure cross-functional alignment.
  • Synthesize external data to inform trial design and strategy.
  • Primary owner/author in data presentation at internal governance meetings; support external presentations.

Qualifications

• Doctoral or advanced clinical/nursing degree (PhD, PharmD, MD, DVM, MSN with advanced clinical specialty, or equivalent) and a minimum of 10 years of combined clinical and/or pharmaceutical industry experience, preferably within clinical development.
• OR BS/MS Degree in a health or scientific discipline and a minimum of 15 years of experience directly related to one or more of the following areas: Clinical/Drug Development (e.g., pharmacology, epidemiology, toxicology, regulatory affairs).

Requirements

• Experience supporting Phase I–III clinical programs.
• Strong understanding of medical governance and regulatory requirements.
• Demonstrated ability to communicate complex scientific data to diverse audiences.
• Proven cross-functional collaboration and stakeholder engagement skills.

Benefits

• Comprehensive benefit program including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).