Associate Director, DMPK

Location
San Francisco, CA
Posted
Oct 11, 2018
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time

The newly created Associate Director of DMPK position will represent the department on clinical and preclinical projects. The scientist in this role will have the opportunity to be the key contributor on a late-stage clinical program. Responsibilities will include sitting on the team that oversees ongoing clinical studies and designing clinical pharmacology studies for clinical programs. Excellent written and oral communication skills are critical for this position.

 Responsibilities: 

  • Represent DMPK on one or more clinical and preclinical project teams
  • Help design clinical pharmacology studies and analyze data; draft relevant sections of clinical study reports
  • Conduct PK analysis for nonclinical studies using Noncompartmental Analysis (NCA) with Phoenix WinNonlin
  • Provide advanced PK and PKPD modeling support using WinNonlin or NONMEM
  • Prepare summary reports of PK analysis for preclinical and clinical studies
  • Work with consultants to develop PBPK and POP PK model development for clinical programs
  • Prepare sections of regulatory submissions such as INDs, NDA/BLA, MAAs, as well as responses to regulatory queries as required

Qualifications: 

  • PhD (or equivalent in education and experience) in a scientific discipline, with ten years’ experience in the biotechnology/pharmaceutical industry performing clinical pharmacology, preclinical, and/or clinical PK/PD analyses
  • Demonstrated proficiency with WinNonlin and/or NONMEM
  • Experience in either small molecule or biomolecule development
  • Good understanding of requirements for bioanalytical assay validations
  • Experience in managing CROs for bioanalysis and other DMPK work
  • Working knowledge of GLP/GCP requirements for nonclinical studies
  • Must be highly organized and have the ability to communicate effectively with internal and external organizations
  • Highly motivated team player willing to contribute to a growing biopharmaceutical company