Senior Director, Global Bioanalysis, (DMPK) for Orexin Programs

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 177,000 - 339,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical/Dental/Vision benefits

Job summary

Lilly is seeking a Senior Director, Global Bioanalysis, DMPK to provide strategic leadership for international bioanalytical and biomarker activities, spanning discovery to clinical development. You will lead a global network of internal teams and external partners, shape biomarker strategies, and drive data-driven decision making.

The role requires deep scientific expertise, strong people leadership, and experience operating in a global drug development environment with up to 20% travel.

Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• 15+ years in biotech/pharma/CRO with increasing leadership responsibility.
• Experience leading bioanalytical and biomarker programs across discovery to clinical development.

Responsibilities

• Lead global bioanalytical function and manage internal/external resources.
• Develop and execute biomarker strategies to guide development decisions.
• Oversee CRO selection, governance, and outsourcing partnerships.
• Mentor and develop direct reports and build organizational capabilities.
• Collaborate across Discovery, Translational Sciences, Toxicology, PK, and Clinical Pharmacology.

Skills

Global leadership

Bioanalysis

LC-MS/MS

Biomarker strategies

CRO management

Regulatory knowledge

Education

Ph.D. in Analytical Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

LC-MS/MS platforms

Analyst/MassLynx/Xcalibur

IND/NDAs regulatory submissions

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.

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 ORX750) – 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 aGreat 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 compliance with GLP, GCP, and applicable global regulatory guidelines.
• Write and maintain standard operating procedures (SOPs) and document key scientific and operational decisions.
• Contribute to the review and interpretation of metabolite profiling and identification studies.
• Support global development programs through engagement with internal and external stakeholders across multiple regions and time zones.
• Travel approximately 10%-20%, including visits to CROs and external partners as needed.

Basic Qualifications

• Ph.D. in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum of 15 years of experience in biotechnology, pharmaceutical, or CRO environments, with increasing leadership responsibility.
• Demonstrated experience leading, developing, and managing scientific teams and direct reports.
• Significant experience supporting bioanalytical and biomarker programs across discovery, translational, preclinical, and clinical development.
• Proven experience managing global CROs and overseeing external assay transfers, validation activities, and strategic outsourcing partnerships.
• Extensive experience working with international vendors and external partners across the US, UK, and EU.
• Strong analytical and problem‑solving skills, with expertise in assay sensitivity, selectivity, reproducibility, and data interpretation.
• Hands‑on experience with quantitative LC‑MS/MS method development and validation for small molecule drug development.
• Proficiency with LC‑MS/MS instrumentation (e.g., Sciex, Waters, Thermo) and associated software platforms (e.g., Analyst, MassLynx, Xcalibur).
• Deep knowledge of global regulatory bioanalytical requirements and guidelines, including FDA, EMA, ICH M10, and GLP/GCP environments.
• Experience supporting Toxicology, Pharmacokinetics (PK), and Clinical Pharmacology programs throughout drug development.
• Prior experience supporting IND-enabling studies and clinical-stage development programs.
• Demonstrated ability to influence and collaborate effectively within a matrixed global organization.
• Excellent written, verbal, and interpersonal communication skills, with the ability to clearly communicate complex scientific concepts to diverse audiences.
• Strong project management, organizational, and stakeholder management capabilities.

Work Location

The Senior Director, Global Bioanalysis, (DMPK) for Orexin Programs role is a based in the EU, UK or US, with travel up to 20%.

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.

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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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

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

$177,000 - $338,800

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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