We are seeking a motivated Associate Director/Director of Clinical Pharmacology to lead strategic clinical pharmacology initiatives for a mid-size biotechnology company focusing on oncology therapies.
Key responsibilities:
- Develop and execute clinical pharmacology strategies for the company's pipeline.
- Design and lead clinical pharmacology study design and analysis for Phases 1-3.
- Assist with Pharmacometrics applications.
- Act as a SME during regulatory interactions and submissions.
- Oversee external CRO management.
Qualifications
- PharmD or PhD in Pharmacology, Pharmaceutical Sciences, or a related field.
- 5+ years of industry experience in Clinical Pharmacology.
- IND/NDA/BLA experience.
- Hands on expertise with software such as Phoenix WinNonLin, NONMEM, R.
