Senior Director, DMPK Project Leader (remote)
About The Position
The Senior Director, DMPK Project Leader ensures delivery of DMPK activities as part of cross-functional program teams. The work includes nonclinical pharmacokinetic experiments, in vitro ADME, biotransformation studies, and bioanalytical and toxicokinetic analysis. The role applies pharmacokinetic, toxicokinetic, and ADME principles to support progression of drug candidates across the portfolio. The position partners with discovery and development teams to identify lead candidates with suitable DMPK properties for nonclinical development and to support their progression into clinical development. Relevant experience includes PK modeling, ideally for CNS drug candidates, an understanding of ADME properties important to CNS candidate progression, and end-to-end drug discovery and development experience, including NDA submissions. The role is based in the US and involves 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.
- Expertise in DMPK sciences and 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 DMPK assays, including 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.
- Ability to work cross-functionally and communicate scientific findings clearly and effectively.
- Collaborative mindset and a sense of urgency.
- Strong, proactive communication skills.
Nice To Haves
- PK modeling experience, ideally for CNS drug candidates.
Responsibilities
- Lead the filing of NDAs for DMPK.
- Deliver high-quality DMPK input and data to projects within established timelines.
- Use DMPK knowledge to support and influence compound profiling, project progression, and project strategy.
- Calculate pharmacokinetic 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.
Benefits
- Company bonus, depending in part on company and individual performance.
- Eligibility to participate in a company-sponsored 401(k).
- Pension.
- Vacation benefits.
- Eligibility for medical, dental, vision, and prescription drug benefits.
- Flexible benefits, including 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 an employee assistance program, fitness benefits, and employee clubs and activities.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
