Description of RoleSenior 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 LocationThe Senior Director, DMPK Project Leader role based in the US, with occasional travel.
CompensationThe annual base salary range for this position is $200,000.00 to $215,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge an location.
In addition to base pay, this role is eligible for a discretionary annual bonus. The Company also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
POSITION: Full-Time, Exempt
