Director DMPK

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 [email protected]

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.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data -