Clinical Pharmacology Manager

Start: Sep 5, Duration: 1yr

 

The successful candidate will have the ability to integrate drug metabolism, pharmacokinetic, biomarker, toxicology and clinical data to assist in the development of of diabetes/oncology compounds. The candidate will report to an Associate Director/Director and work with them to advance multiple compounds by proficiently integrating PK/PD and clinical data to evaluate/simulate optimal doses/regimens, exposure-response, exposure-safety analyses, etc. to support the early clinical development strategy.

The candidate must be able to design and write clinical PK protocol synopses, PK analysis plans, study reports, and other clinical documents. The candidate should also have experience in writing regulatory documents such as INDs, IBs and IMPDs.

The ability to work independently to analyze, interpret and apply new clinical data to refine the early clinical development plan is essential. Excellent computer skills, particularly in the preparation of Powerpoint presentation materials, analysis of data in Excel and the preparation of graphs, is essential. The candidate may participate in cross-functional and clinical teams.

Doctorate degree in pharmaceutical sciences, pharmacokinetics, medicine or related discipline. Must have a comprehensive understanding of principles of clinical pharmacokinetics and pharmacodynamics from clinical pharmacology/pharmacokinetic drug development and data analysis experience. Understanding of issues related to clinical safety/toxicology is advantageous. Excellent oral and written communication skills as well as demonstrated ability to work effectively with people and lead teams is essential.

Experience using standard PK software (e.g. WinNonlin, NONMEM) is helpful and knowledge of the diabetes and oncology therapeutic areas is an advantage.