Senior Director, Global Bioanalysis – DMPK

Eli Lilly and Company

. Lead the global bioanalytical function and manage internal and external resources .

Posted 9/19/2026full-timeRemote • United States, United KingdomSenior💰 $177,000 - $338,800 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in bioanalytical and biomarker strategies, with a strong focus on managing global CROs and leading scientific teams. Proficient in regulatory compliance and data interpretation to support drug development across various stages.

Highest-signal resume keywords

Ph.D. In Analytical ChemistryBioanalytical And Biomarker Program ManagementLC-MS/MS Method Development And ValidationGlobal CRO ManagementRegulatory Compliance (GLP, GCP, FDA, EMA)

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Applicant Tracking System Keywords

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Hard Skills

Bioanalytical Data AnalysisAssay Sensitivity And SelectivityQuantitative LC-MS/MSMethod Development And ValidationRegulatory Submission (INDs, NDAs)

Soft Skills

Leadership And Team DevelopmentCollaboration In Matrixed OrganizationsStrong Communication SkillsProject ManagementStakeholder Management

Tools & Technologies

LC-MS/MS InstrumentationSciexWatersThermoAnalyst SoftwareMassLynxXcalibur

Industry Keywords

BiotechnologyPharmaceuticalCRO EnvironmentsToxicologyPharmacokinetics

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the global bioanalytical function and manage internal and external resources
Provide strategic leadership and functional ownership for bioanalytical and biomarker activities across discovery, translational, preclinical, and clinical development programs
Develop and execute biomarker strategies to support research objectives and 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
Foster a collaborative team culture across geographically distributed employees, contractors, and external partners
Oversee functional budgets, forecasting, resource planning, vendor/CRO spend management, and financial oversight
Represent bioanalysis in cross-functional leadership discussions and project teams
Partner with Discovery, Translational Sciences, Toxicology, PK, Clinical Pharmacology, Regulatory Affairs, and Clinical Development teams globally
Build and maintain relationships with global CROs, laboratories, and external vendors
Oversee CRO selection, governance, performance management, and issue resolution
Manage CROs for method transfer, qualification/validation, sample analysis, and data review
Review statements of work for alignment with project objectives
Analyze and interpret bioanalytical data
Author and review study plans, method development summaries, validation reports, and regulatory submission sections, including INDs and NDAs
Track deliverables and communicate progress, risks, and recommendations
Ensure compliance with GLP, GCP, and global regulatory guidelines
Write and maintain SOPs and document scientific and operational decisions
Contribute to metabolite profiling and identification studies
Support global development programs across multiple regions and time zones
Travel approximately 10%-20% to CROs and external partners

Requirements

What you’ll need

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
Experience leading, developing, and managing scientific teams and direct reports
Experience supporting bioanalytical and biomarker programs across discovery, translational, preclinical, and clinical development
Experience managing global CROs and overseeing external assay transfers, validation activities, and strategic outsourcing partnerships
Experience working with international vendors and external partners across the US, UK, and EU
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, including Sciex, Waters, or Thermo, and associated software platforms such as Analyst, MassLynx, or Xcalibur
Knowledge of global regulatory bioanalytical requirements and guidelines, including FDA, EMA, ICH M10, and GLP/GCP environments
Experience supporting Toxicology, Pharmacokinetics, and Clinical Pharmacology programs throughout drug development
Experience supporting IND-enabling studies and clinical-stage development programs
Ability to influence and collaborate within a matrixed global organization
Strong written, verbal, and interpersonal communication skills
Strong project management, organizational, and stakeholder management capabilities

Benefits

Comp & perks

Company bonus depending on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
Remote work arrangement