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.

Purpose:

• Partner early on asset development with Research (including Discovery Biologists, Therapeutic Area Biomarker Scientists, PK/PD, Clinical Diagnostic Laboratory, Tailoring Scientists and Laboratory of Experimental Medicine) to develop and document the Biomarker strategies and plans at the molecule and trial level.
• Together with the CLS Therapeutic Area (TA) P4, Influence protocol design in regards biomarkers and sample collections to advocate for the patient/site
• Provide expertise and consultation to Study Teams on Biomarkers planning
• Facilitate and share findings across the collective CLS organization as well as feedback loops to clinical design and Discovery Research
• Work to improve existing processes and to implement new processes within the biomarker space
• Identify key functional capability gaps early enough to help ensure robust processes in place to meet team needs and/or manage expectations to avoid downstream delivery delays
• Partner with the TA P4, the CLS Biomarker Hub and the CLS Sourcing Consultants to provide insights into the operationalization of the Biomarker Plan (vendor selection, method selection)
• Partner with the experts within and outside of CLS to plan and conduct the review of method validation reports when needed
• Ensure that key actions related to Biomarkers including, but not limited to, reviewing regulatory approvals and engaging the Companion Diagnostic and Regulatory Team, are performed effectively and on time
• Identify and articulate the future Biomarker needs of the portfolio to vendors

• Manage key partnerships and interactions/integration across the cross functional Biomarker team
• Proactively identify critical decision points that must be made and ensure that the key technical/scientific experts are involved
• Bring greater value to the portfolio by anticipating Biomarker issues and opportunities
• Drive communications to prospectively manage upcoming cross-functional activities, key achievements and decisions as well as proactively partner to optimize the timeline
• Support the CLS TA P4 in the articulation of solutions in terms of reliability, time, cost, quality and scalability

• Serve as a Biomarker expert to the Clinical Laboratory Sciences Associates
• Model the Lilly leadership behaviors
• Provide coaching within the organization that fosters inclusion and innovation, improvement, and an external awareness and understanding

• Bachelor’s degree or higher in a scientific field with 5 years’ experience in clinical research, clinical development or laboratory assay development or a Ph D in a related field

• Exceptional and demonstrated learning agility
• Ability to understand the Biomarker needs of each therapeutic area
• Ability to set and implement biomarker strategies
• Strong communication and organizational skills.
• Laboratory professional certification through an accrediting body, such as the American Society for Clinical Pathology (ASCP)
• Familiarity with biomarker assay global regulatory requirements
• Effectively partner/influence cross functionally to deliver results
• Ability to lead development of creative Biomarker solutions to address clinical development challenges
• Ability to develop diverse organizational talent and grow biomarker technical depth in others
• Domestic and international travel (10%), required

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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