Senior Director, DMPK Project Leader

🔥 17 hours ago

🇺🇸 United States – 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

• Ensure delivery of all DMPK-related activities as part of a cross-functional program team • Support nonclinical PK experiments, in vitro ADME, biotransformation studies, bioanalytical analysis, and toxicokinetic analysis • Apply pharmacokinetic, toxicokinetic, and ADME principles to enable drug candidate progression across the portfolio • Partner with discovery and development teams to identify lead candidates with optimal DMPK properties • Support progression of lead candidates into nonclinical and clinical development • Lead the filing of NDAs for DMPK • Deliver high-quality DMPK input and data within established timelines • Use DMPK knowledge to support and influence compound profiling, project progression, and project strategy • Calculate PK and toxicokinetic parameters, estimate safety margins, and report results and interpretations to project teams and internal governance bodies • Lead, coordinate, and engage with DMPK colleagues, clinical pharmacologists, and toxicologists in project-related activities • Prepare presentations for internal governance bodies

🎯 Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmacology or a related field • Minimum of 10 years of industry experience in a biotech or pharmaceutical setting • Expert in DMPK sciences with knowledge of drug discovery and development processes • Strong analytical and problem-solving skills • Experience in DMPK project leadership • Previous work in the discovery and/or development of CNS drug candidates • Experience with regulatory submissions including NDAs for small molecules • Knowledge, experience, and proficiency in supporting GLP-compliant studies • Good knowledge of all DMPK assays including the use of in silico tools for PK prediction • Proficiency with Phoenix WinNonlin and other software for NCA and PK modeling in small molecule drug discovery and development • Demonstrated ability to work cross-functionally and communicate scientific findings clearly and effectively • Collaborative mindset and operates with a sense of urgency • Strong, proactive communication skills

🏖️ Benefits

• Company bonus depending, in part, on company and individual performance • Company-sponsored 401(k) • Pension • Vacation benefits • Medical, dental, vision and prescription drug benefits • Healthcare and/or dependent day care flexible spending accounts • Life insurance and death benefits • Certain time off and leave of absence benefits • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities