Senior Director, Global Bioanalysis – DMPK
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Job Description
Senior Director leading global bioanalysis and biomarker strategy for Lilly subsidiary Centessa’s orexin medicines. Overseeing CROs, regulatory submissions, and cross-functional drug development.
Responsibilities:
- 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:
- 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:
- 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
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