Senior Director, DMPK Project Leader (remote)
Eli Lilly and Company
Summary
Senior Director, DMPK Project Leader ensures delivery of all DMPK related activities working collaboratively as part of a cross-functional program team. These include nonclinical PK experiments, in vitro ADME, biotransformation studies, bioanalytical and toxicokinetic analysis. This role supports understanding pharmacokinetic, toxicokinetic, and ADME principles to enable progression of drug candidates across the portfolio.
Job description
Description of Role
Senior Director, DMPK Project Leader ensures delivery of all DMPK related activities working collaboratively as part of a cross-functional program team. These include nonclinical PK experiments, in vitro ADME, biotransformation studies, bioanalytical and toxicokinetic analysis. This role supports understanding pharmacokinetic, toxicokinetic, and ADME principles to enable progression of drug candidates across the portfolio.
A qualified candidate will have previous experience in PK modeling ideally for CNS drug candidates and a basic understanding of vital ADME properties for CNS drug candidate progression. Furthermore, a qualified candidate will have end-to-end experience in drug discovery and development including NDA submission; will be able to partner with both discovery and development teams to enable the identification of lead candidates with optimal DMPK properties for progression into nonclinical development and the progression of lead candidates into clinical development.
Key Responsibilities
- Lead the filing of NDAs for DMPK
- Deliver high-quality DMPK input and data to projects within established timelines
- Utilize knowledge of DMPK to support/influence compound profiling, project progression and project strategy
- Proactively 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 related to the above for internal governance bodies
Qualifications
- 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
Work Location
The Senior Director, DMPK Project Lead role based in the US, with occasional travel.
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
- 401(k)
- Pension
- Vacation benefits
- Medical, Dental & Vision
- Prescription drug benefits
- Flexible spending accounts
- Life insurance
- Death benefits
- Time off
- Leave of absence
- Employee assistance program
- Fitness benefits
- Employee clubs and activities
- Company bonus
Company overview
Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.