Director DMPK
Director DMPK
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1 Vacancy
Job Description
Job Description
Job Title: Director DMPK
Location: Greater San Francisco Area In the office 2 days a week with the option of working remotely 3 days a week.
Summary:
Were partnered with one of Californias most exciting biotech companies in their search for a Director DMPK to join their fun passionate and talented Director of DMPK leads the development of ADME/PK/PKPD strategies for small molecule discovery and development by providing technical and scientific leadership.
You will work closely with several R&D functional areas as an SME to support DMPK facilitating decisionmaking for project advancement including FIH dose estimations. As the DMPK lead you will oversee the design implementation interpretation and reporting of studies. You must have prior experience preparing and reviewing regulatory filing documentation in order to support IND IB FIH CTA and NDA/BLA files.
Responsibilities:
- Develop and implement DMPK and PKPD strategies to support the selection and development of small molecules.
- Participate in 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.
Qualifications:
- 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.
- Design/conduct of experiments to understand drug disposition profiles and PKPD relationships for program advancements and translation from preclinical to clinical.
- Handon analysis of PK and PKPD data using applicable software.
- Firstinhuman dose projections.
- Regulatory document preparation and interactions with US and international regulatory agencies.
- Managing CROs/vendors and consultantsability 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.
- Detailoriented with ability and desire to work in a fastpaced teamoriented handson small company environment.
Required Experience:
Director
Employment Type
Full-Time
