Director – Molecular Biomarkers
PharmaBiotechClinical ResearchRegulatory AffairsQuality Assurancegcpemacroinform
Job description
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Laboratory Operations & Analytical Sciences Lead Cardiometabolic Translation & Biomarker Research (CTBR) Lilly relies on biomarker research to understand disease etiology, onset, and progression, to characterize therapeutic outcome, and to identify and validate therapeutic targets. The CTBR group at the Lilly Corporate Center in Indianapolis operates diverse analytical capabilities — spanning immunoassays, clinical chemistry, and mass spectrometry — to support drug discovery and development across cardiometabolic pillars (obesity, diabetes, cardiorenal, women’s health, aging etc) and therapeutic modalities. The Opportunity We are seeking a highly organized scientific, technical, and operational leader for CTBR’s multi-capability molecular biomarker laboratory. Acting as a central node internal to the laboratory, this individual helps coordinate day-to-day execution across analytical capabilities, helps lead and develop the team, and provides scientific and technical leadership across clinical chemistry, mass spectrometry, and multiplex immunoassay platforms. The role focuses on managing and scaling the laboratory’s routine capabilities as they expand — taking on assays and methods once their development is transferred into operations — and on integrating and collaborating with adjacent groups, including those dedicated to immunohistochemistry and morphological assessments and teams supporting advanced method development. This role represents CTBR to collaborates with discovery biologists and clinical scientists to define the biomarker need and best analytical approach. We welcome candidates from analytical chemistry, biochemistry, biology, and clinical laboratory backgrounds. Purpose of the Job Serve as senior scientific/technical resource and laboratory operations lead for CTBR’s molecular biomarker capabilities, supporting the seamless, high-quality execution of preclinical and clinical biomarker studies, the day-to-day running and expansion of routine assays, and the mentoring and development of laboratory staff. The individual acts as a trusted, collaborative partner across the laboratory’s capabilities and with the project teams it serves. Key Responsibilities Laboratory Operations Leadership – Serve as the lab operation lead to ensure seamless execution of biomarker studies across different capabilities. Support and coordinate the day-to-day operational planning and execution of preclinical and clinical biomarker studies, overseeing sample logistics, chain-of-custody, inventory, and laboratory information management systems (LIMS). Manage and scale the laboratory’s routine molecular capabilities as they expand, taking on new assays and methods once their development is transferred into operations. Apply strong project-management rigor to plan, track, and deliver against timelines, deliverables, and performance metrics, so that commitments to project and clinical teams are met reliably and reproducibly. People Leadership and Cross-Capability Coordination – Mentor, develop, and help lead a team of laboratory scientists and associates, and help coordinate and connect work across the laboratory’s analytical capabilities. Support workforce and capacity planning, workload balancing, scheduling, and prioritization so that the right expertise is applied to the right studies at the right time, and help shape team roles and development paths as the laboratory grows. Integrate and collaborate with adjacent groups — including those dedicated to immunohistochemistry and morphological assessments alongside this laboratory’s molecular assessments, and teams supporting advanced method development. Foster a collaborative, standardized, and safety-conscious culture; be an active source of mentoring and feedback; and model the Lilly leadership behaviors as an ambassador for both patients and the Lilly brand. Quality, Data Integrity, and Transparency – Support preclinical, in-protocol and post-hoc exploratory biomarker work by working with internal labs or external vendors following appropriate quality expectations. Support clinical biomarker studies that meet regulatory requirements (GCP/GCLP/CLIA). Bring a compliance-focused, transparent, and well-organized way of working to this discovery laboratory — contributing to clear SOPs, robust quality-control strategies, rigorous data review, and traceable documentation that keep results reliable and reproducible, consistent with Lilly research policies and good scientific practice. Analytical Science and Technical Leadership – Provide scientific and technical leadership for the qualification and troubleshooting of clinical chemistry and pathology methods and assays (Roche Cobas analyzers) and other novel multi-plex assay platforms. Provide scientific direction and support for the development, qualification, validation, and transfer of targeted quantitative assays in biological matrices — spanning small molecules (e.g., LC-MS/MS, GC-MS) and large molecules (e.g., ELISA, MSD, protein LC-MS) — working closely with senior technical associates who hold hands-on platform expertise, and serve as a senior scientific troubleshooting resource for the laboratory. Translational Biology and Biomarker Strategy – Develop and implement novel preclinical and clinical biomarker strategies to inform mechanism of action, efficacy, and safety of Lilly assets. Interpret biomarker data in a physiologic and pathophysiologic context relevant to cardiometabolic disease, and advise and support project teams on clinically meaningful translational opportunities. Standardization, Analytical and Data Integration – Support and promote standardization of laboratory processes to improve consistency, reproducibility, and data integrity. Evaluate and integrate a broad range of analytical tools and platforms as appropriate for the science, connecting the right capabilities to the scientific question at hand. Strengthen the analysis, mining, and integration of data generated across the laboratory to extract robust biological insight for biomarker research, applying modern computational and AI approaches where they make valuable contributions. Basic Requirements Ph.D. in analytical chemistry, biochemistry, biology, chemical biology, clinical/laboratory science, or a related scientific field. At least 5 years of relevant laboratory research experience in a bioanalytical, biomarker, or clinical laboratory setting, including demonstrated leadership of people, projects, or laboratory operations. Additional Skills / Preferences Direct experience with clinical chemistry analyzers (e.g., Roche Cobas) and/or multiplex immunoassay platforms (e.g., MSD, Luminex, Olink). Hands-on mastery of one or more analytical platforms, for example LC-MS/MS or GC-MS for small molecules, or ELISA/MSD and protein LC-MS for large molecules, is valued; breadth across all platforms and molecule types is not expected at this level. Working knowledge of
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