Associate Director/ Director, Regulatory Affairs Scientist, Chemistry
DIRECTOR DMPK

BRIS.128

UNITY biotechnology is committed to developing therapeutics to extend human healthspan by slowing, halting or reversing the diseases of aging.   Located in the heart of the biotechnology industry near South San Francisco, we are seeking a scientific leader to oversee DMPK efforts as Director of DMPK.  The role will be involved in the design, execution, analysis, interpretation and communication of PK/ADME studies of small molecule and biologics and their associated delivery system to provide PK/ADME characteristics to support drug development.  This position requires strong intellectual leadership, working at the interface of discovery and development teams and will serve as the nonclinical subject matter expert. This position requires knowledge of PK/PD modeling to facilitate prediction of exposure required in humans.

Key Responsibilities:

  • Represent DMPK as the subject matter expert for nonclinical development
  • Responsible for the analysis, interpretation, integration and reporting of nonclinical DMPK data generated both internally and with external vendors/academic sites
  • Review and interpret bioanalytic data and reports.
  • Participate in the management of CROs/academic sites in the conduct of in vitro/in vivo ADME and DMPK modeling studies and future potential to set up in-house laboratory capabilities
  • Lead and prepare DMPK components of nonclinical and clinical study protocol designs, nonclinical and clinical study reports, and investigator brochures.
  • Prepare strategic and scientifically sophisticated DMPK drug development strategies that meet regulatory requirements and program goals.
  • Author high quality Regulatory documents including INDs, CTAs and NDA filings.
  • Partner with and support Toxicology, Research, Clinical, Regulatory, Project Management and other departments.
  • Participate in the preparation of abstracts and manuscripts for publication

REQUIREMENTS:

  • PhD. in Pharmacokinetics, Pharmacology, Pharmaceutics or other relevant field with 10-15 years of experience in the biopharmaceutical industry, with evidence of drug development experience. Experience in local delivery of therapeutics (ocular, pulmonary, intra-articular) is a plus.
  • Strong knowledge of ADME concepts, pharmacokinetic modeling, pharmacodynamic and bioanalytical principles. Proficient in standard MS software (Word, Excel and Power Point) and experience using WinNonlin or other pharmacokinetic software.
  • Strong communication skills (verbal and written) and presentation skills required. Excellent interpersonal skills and ability to represent DMPK in a team environment are essential.

Please send resume and cover letter