Director - Clinical Research Scientist-Clinical Development

Lilly•Indianapolis, IN

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying. 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. This role leads trial design and execution in close partnership with regulatory, statistics, NPP, medical affairs, and translational teams to deliver patient-focused outcomes.

Requirements

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)

Nice To Haves

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

Responsibilities

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
Design and execute enrollment plans including country and site selection, PI identification, and risk mitigation/trend monitoring
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
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

Benefits

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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