Position Overview:
This role involves leading efforts within the drug metabolism and pharmacokinetics (DMPK) area, working closely with multidisciplinary project teams to provide scientific insight and direction. The individual will oversee DMPK studies to support the company's drug development programs, both preclinical and clinical, and will contribute to project strategy and innovation. The position requires the ability to design, implement, and manage pharmacokinetic (PK), pharmacodynamic (PK-PD), and drug metabolism studies, combining various data points to optimize drug candidates. Responsibilities include preparing study reports, presenting data, and participating in regulatory submissions.
Key Responsibilities:
- Act as the DMPK representative on cross-functional project teams
- Oversee and guide DMPK studies that support drug development
- Design and execute PK, PK-PD, and drug metabolism studies
- Collaborate with medicinal chemistry teams to optimize drug profiles
- Integrate ADME, PK, and PK/PD data with biological findings
- Manage in vivo and in vitro ADME/PK studies
- Conduct modeling of PK and PK/PD, and predict human pharmacokinetics
- Analyze DMPK data and develop studies to address project needs
- Summarize and present findings to stakeholders and teams
- Contribute to regulatory documents supporting drug development
- Author nonclinical PK/ADME documents for submissions
- Lead and support the in-house DMPK team
- Coordinate with contract research organizations (CROs) to ensure study quality and timelines
Desired Qualifications:
- PhD in a relevant scientific field, such as Biochemistry or Pharmaceutical Sciences, with at least 10 years of industry experience
- Strong expertise in pharmacokinetics, drug metabolism, modeling, enzyme kinetics, and bioanalytical techniques
- Experience designing and executing PK and PK-PD studies
- Familiarity with preparing nonclinical PK/ADME documents for regulatory submissions
- Proficient in software like Phoenix WinNonlin, Excel, and Prism; knowledge of PBPK modeling is a plus
Core Competencies:
- Strong communication and leadership skills
- Ability to work effectively both independently and as part of a team
- Expertise in data-driven analysis and drug development strategies
- Experience managing CRO relationships and a solid understanding of regulatory standards
- Proven ability to lead studies that contribute to drug discovery and regulatory filings
