Careers
Associate Director, Clinical Pharmacology (ADP-413)
Ambit Biosciences is a privately-held biopharmaceutical company engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. Ambit Biosciences has the technology, the expertise, and the vision to succeed in the kinase space. We are seeking a talented Associate Director, Pharmacokinetics.
The Associate Director of Clinical Pharmacology will support clinical PK, metabolism, and PK/PD for Ambit's development programs. She/he will focus on clinical trials, including phase 1, clinical pharmacology, and PK within efficacy studies She/he will be responsible for processing and interpreting PK/TK data, reviewing and preparing non-clinical and clinical documentation for regulatory submissions, and participating in drug development project teams. The incumbent, in cooperation with the DMPK and Toxicology groups and other project team members, will assess and recommend doses/regimens for molecules in clinical development.
Key responsibilities will include, but are not limited to:
- Participating in early stage development including IND enabling activities through Phase 2.
- Developing and reviewing preclinical and clinical protocols and providing scientific/technical input for bioanalytical, preclinical ADME and toxicology, and clinical protocols.
- Analyzing preclinical and clinical PK, TK, and PK/PD data.
- Writing and reviewing preclinical and clinical reports.
- Reviewing and preparing non-clinical and clinical documentation intended for regulatory submissions.
Knowledge, Skills, Experience, and Education Required:
- Ph.D. or PharmD in Pharmacokinetics, Pharmaceutical Sciences, or related scientific discipline.
- Minimum of six (6) years of Pharmacokinetics experience in Biotech/Pharmaceutical industry.
- Experience with clinical and/or non-clinical popPK and PK/PD modeling using standard software is desired (ie WinNonlin, NONMEM, SAS).
- Strong interpersonal relationship skills with a proven ability to drive pharmacokinetic strategies/understanding at the project team level
- Excellent written and oral communication skills and strong computer skills are essential
- Expertise in biostatistics and/or advanced modeling a plus.