DMPK Project Lead

6 hours ago

San Diego, California, United States BioPhase Solutions Full time
Job Title: DMPK Project Representative

At BioPhase Solutions, we are seeking a highly skilled DMPK Project Representative to join our team. As a key member of our drug development team, you will be responsible for leading efforts within the drug metabolism and pharmacokinetics (DMPK) area, working closely with multidisciplinary project teams to provide scientific insight and direction.

Key Responsibilities:
  • Act as the DMPK representative on cross-functional project teams, ensuring seamless collaboration and communication.
  • Oversee and guide DMPK studies that support drug development, from preclinical to clinical stages.
  • Design and execute pharmacokinetic (PK), pharmacodynamic (PK-PD), and drug metabolism studies, combining various data points to optimize drug candidates.
  • Collaborate with medicinal chemistry teams to optimize drug profiles, leveraging your expertise in ADME, PK, and PK/PD data.
  • Integrate ADME, PK, and PK/PD data with biological findings, providing a comprehensive understanding of drug behavior.
  • Manage in vivo and in vitro ADME/PK studies, ensuring high-quality results and timely delivery.
  • Conduct modeling of PK and PK/PD, and predict human pharmacokinetics, providing valuable insights for drug development.
  • Analyze DMPK data and develop studies to address project needs, driving innovation and progress.
  • Summarize and present findings to stakeholders and teams, effectively communicating complex scientific information.
  • Contribute to regulatory documents supporting drug development, ensuring compliance with industry standards.
  • Author nonclinical PK/ADME documents for submissions, showcasing your expertise and attention to detail.
  • Lead and support the in-house DMPK team, fostering a collaborative and dynamic work environment.
  • Coordinate with contract research organizations (CROs) to ensure study quality and timelines, maintaining strong relationships and open communication.
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, with a proven track record of success.
  • Familiarity with preparing nonclinical PK/ADME documents for regulatory submissions, ensuring compliance and accuracy.
  • Proficient in software like Phoenix WinNonlin, Excel, and Prism, with knowledge of PBPK modeling a plus.
Core Competencies:
  • Strong communication and leadership skills, with the ability to work effectively both independently and as part of a team.
  • Expertise in data-driven analysis and drug development strategies, with a focus on innovation and progress.
  • Experience managing CRO relationships and a solid understanding of regulatory standards, ensuring compliance and quality.
  • Proven ability to lead studies that contribute to drug discovery and regulatory filings, with a strong track record of success.

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