Senior Director, Global Bioanalysis; DMPK) Orexin Programs
Job in
Indianapolis, Marion County, Indiana, 46202, USA
Listed on 2026-09-22
Listing for:
Lilly
Full Time
position Listed on 2026-09-22
Job specializations:
-
Management
Regulatory Compliance Specialist, Project & Program Management
Job Description & How to Apply Below
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.
** Overview*
* Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's lead investigational candidate - cleminorexton (formerly ORX
750) - is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a
** Great Place to Work** ® in 2026.
The Senior Director, Global Bioanalysis, DMPK provides strategic leadership for international bioanalytical and biomarker activities supporting programs from discovery through clinical development. This role is responsible for defining and executing bioanalytical strategies that enable data-driven decision-making across the portfolio. Working closely with Discovery, Translational Sciences, Toxicology, PK, and Clinical Pharmacology teams, the individual will lead bioanalytical efforts across a global network of external partners and CROs.
The position requires deep scientific expertise, strong people leadership, and experience operating in a global drug development environment.
** Responsibilities*
* + Lead the global bioanalytical function, including management and development of internal and external resources.
+ Provide strategic leadership and functional ownership for bioanalytical and biomarker activities supporting discovery, translational, preclinical, and clinical development programs.
+ Develop and execute biomarker strategies that support discovery and translational research objectives and inform key development decisions.
+ Manage, mentor, and develop direct reports through goal setting, performance management, career development, succession planning, and scientific leadership.
+ Lead recruitment, onboarding, and retention efforts to build organizational capabilities and scale the function as programs advance.
+ Foster a collaborative, high-performing team culture across geographically distributed employees, contractors, and external partners.
+ Oversee functional budgets, including forecasting, resource planning, vendor/CRO spend management, and financial oversight to ensure efficient use of resources.
+ Represent the bioanalytical function in cross-functional leadership discussions and project teams, providing scientific input into portfolio strategy, development plans, and key program decisions.
+ Serve as a key partner to Discovery, Translational Sciences, Toxicology, Pharmacokinetics (PK), Clinical Pharmacology, Regulatory Affairs, and Clinical Development teams across the US, UK, EU and other global regions.
+ Build and maintain strategic relationships with global CROs, laboratories, and external vendors to ensure alignment with program objectives, quality standards, and timelines.
+ Provide strategic oversight of CRO selection, governance, performance management, and issue resolution.
+ Collaborate with and manage CROs for method transfer, qualification/validation, sample analysis, and data review; ensure data integrity and timely delivery of results.
+ Review statements of work (SOWs) to ensure alignment with project objectives and organizational priorities.
+ Analyze and interpret bioanalytical data, ensuring accuracy, consistency, and scientific rigor.
+ Author and review study plans, method development summaries, validation reports, and technical sections of regulatory submissions, including INDs and NDAs.
+ Track study deliverables and communicate progress, risks, and recommendations to cross-functional teams and senior management.
+ Ensure…
Position Requirements
10+ Years
work experience
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