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Director DMPK

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Proclinical

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Location:
United States , Palo Alto

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

190000.00 - 240000.00 USD / Year
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Job Description:

Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science. Proclinical is seeking a Director of DMPK to join a dynamic and innovative clinical-stage biotechnology environment. In this senior leadership role, you will drive DMPK strategy from discovery through clinical development, focusing on advancing small-molecule therapies for immune-mediated inflammatory diseases. This position offers the opportunity to collaborate across functions in a fast-paced, team-oriented setting.

Job Responsibility:

  • Develop and implement DMPK and PK-PD strategies aligned with discovery and development goals
  • Serve as the DMPK program lead, overseeing study design, execution, data analysis, interpretation, and reporting
  • Provide expert insights on DMPK data and present findings to project teams, senior leadership, and external stakeholders
  • Collaborate with cross-functional teams, including medicinal chemistry, toxicology, pharmacology, CMC, and clinical groups, to support data-driven decision-making
  • Manage bioanalytical and DMPK studies conducted internally and through external partners (CROs)
  • Author and review DMPK-related sections of regulatory documents such as IND, IB, CTA, NDA, and BLA, and address regulatory inquiries
  • Support clinical pharmacology activities, including first-in-human dose projections
  • Ensure high standards of scientific rigor, quality, and documentation throughout all processes

Requirements:

  • Advanced degree (PhD) in pharmacokinetics, drug metabolism, or a related field
  • Expertise in small-molecule DMPK with experience spanning discovery and development
  • Proficiency in analyzing PK and PK-PD data using relevant software tools
  • Strong understanding of regulatory guidelines for small-molecule drug development
  • Experience preparing regulatory submissions and interacting with regulatory agencies
  • Ability to oversee bioanalytical method development and validation
  • Excellent communication, analytical, and problem-solving skills
  • Leadership capabilities with a detail-oriented and adaptable approach in a fast-paced environment

Additional Information:

Job Posted:
April 16, 2026

Employment Type:
Fulltime
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