Senior Pharmacokinetics and Drug Metabolism Leader
3 weeks ago
Job Summary:
BioPhase is seeking a highly experienced Senior Pharmacokinetics and Drug Metabolism Leader to lead our DMPK and pharmacokinetics efforts. The ideal candidate will have a strong background in pharmacokinetics, drug metabolism, and modeling, with a proven track record of designing and executing PK and PK-PD studies.
Key Responsibilities:
- Lead DMPK studies to support drug development, working closely with cross-functional project teams
- Design and execute PK, PK-PD, and drug metabolism studies, combining various data points to optimize drug candidates
- 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
Requirements:
- 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
What We Offer:
- A dynamic and collaborative work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package
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