Clinical Biomarker Lead - Eli Lilly and Company

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Purpose:Clinical Biomarker Lead will have early engagement with the Exploratory Medicine (EMP) area, late phase therapeutic area and CLS partners on development of the biomarker strategies at the trial level. The clinical biomarker lead engages at a trial level with the therapeutic area, clinical design and other appropriate partners to develop a Biomarker plan that can be implemented by the CLS team for the trial. The role requires in-depth understanding of Biomarkers (definition, types, uses, regulatory landscape)Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your most current job responsibilities and any related duties that may be required for the position.Biomarker Strategy and Planning

• 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

Project Management

• 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

People Development

• 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

Minimum Qualification Requirements:

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

Other Information/Additional Preferences:

• 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

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