Senior Director, DMPK Project Leader

🔥 0 minutes 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 global pharmaceutical company that researches, develops, manufactures, and distributes prescription medicines and provides patient support services. The company focuses on life-changing medicines across conditions such as diabetes, cancer, Alzheimer’s disease, autoimmune disorders, dermatology, migraine, obesity, and sleep apnea; it runs clinical trials, offers LillyDirect pharmacy services, and emphasizes manufacturing quality, medication safety, and research into genetic medicines. Eli Lilly also provides patient resources, condition education, and access programs to help people find care and participate in trials.

📋 Description

• Lead the filing of NDAs for DMPK • Deliver high-quality DMPK input and data to projects within established timelines • Utilize 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 clear presentations for internal governance bodies • Ensure delivery of all DMPK-related activities, including nonclinical PK experiments, in vitro ADME, biotransformation studies, bioanalytical analysis, and toxicokinetic analysis • Partner with discovery and development teams to identify lead candidates with optimal DMPK properties and progress candidates into nonclinical and clinical development

🎯 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 • Role is based in the US with occasional travel

🏖️ 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 • Time off and leave of absence benefits • Well-being benefits, including employee assistance program and fitness benefits • Employee clubs and activities