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Job type: Permanent

Discipline: Senior/Director & VP

Location: United States

Director, DMPK - Permanent - Palo Alto, CA

Proclinical is seeking a highly motivated, dynamic Director of DMPK who enjoys working with passionate and talented coworkers.

Skills & Requirements:

PhD in PK, drug metabolism, or a related discipline with at least 10 years of relevant industry experience or equivalent experience based on training and experience.
Experience with Clinical candidate selection and development of small molecules.
Knowledge on the conduct of experiments to understand drug disposition profiles and PK-PD relationships for program advancements and translation from preclinical to clinical.
Previous experience in hands-on analysis of PK and PK-PD data using applicable software.
Knowledge on regulatory document preparation and interactions with US and international regulatory agencies.
Ability to oversee bioanalytical studies and support clinical pharmacology as needed.
Understanding of regulatory guidelines to support small molecule drug development.
Excellent written and interpersonal communications.
Proven problem-solving and analytical abilities.
Detail-oriented with ability and desire to work in a fast-paced, team-oriented, hands-on, small company environment.

The Director of DMPK' responsibilities will be:

Develop and implement DMPK and PK-PD strategies to support timely selection and development of small molecules.
Participate on discovery and development project teams while providing scientific/functional leadership.
Build and maintain strong collaborative partnerships with medicinal chemistry, research, toxicology, technical operations/CMC, and clinical groups.
Design, oversee, and analyze DMPK studies while timely communicating study results to project teams and senior management.
Manage contract research organizations (CROs)/vendors and consultants.
Be responsible for or author PK sections of regulatory submissions and respond to questions from regulatory agencies.
Address additional responsibilities related to DMPK as they arise.

Compensation:

$215,000 to $220,000 per annum.

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at s.amark@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC