Director DMPK - Permanent - Bay Area, CA
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.
Primary Responsibilities:
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.
Skills & 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.
The Director's responsibilities will be:
- 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.
Compensation:
- $190,000 to $240,000 per annum, dependent on experience.
If you are having difficulty in applying or if you have any questions, please contact Neil Walton at n.walton@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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