Director - Clinical Research Scientist-Clinical Development

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.

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.

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

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)

• 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

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

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).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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