Senior Director, Global Bioanalysis – DMPK

🔥 1 minute ago

🌐 United States, United Kingdom – Remote

🇺🇸 United States – Remote 🇬🇧 United Kingdom – Remote

💵 $177k - $338.8k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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