Career Opportunities
Department: Research & Development
Job Title: Director of Drug Metabolism and Pharmacokinetics
Description:
The Director of Drug Metabolism and Pharmacokinetics will supervise the technical activities of product development relating to the metabolic and pharmacokinetic evaluation of potential new products and will develop the external relationships and infrastructure associated with these functions.
- This position will lead the metabolic and pharmacokinetic evaluation of all new drugs and drug dosage formulations under development by NeurogesX. This includes support of clinical development.
- The Director will work very closely with the NeurogesX team members responsible for medicinal chemistry and formulation development to provide rapid iterative feedback for new products.
- This position is responsible for strengthening and coordinating the Company's resources and infrastructure in the areas of drug metabolism and pharmacokinetics.
- This individual will interact regularly with regulatory agencies (both FDA and EMEA) and external collaborators such as corporate partners.
- The successful candidate will report to the Senior Vice President, Nonclinical Research & Development.
Specifically, the Director of Drug Metabolism and Pharmacokinetics will:
- Be responsible for all aspects of drug metabolism and pharmacokinetics, including support of clinical study bioanalysis.
- Design and supervise studies at contract research organizations.
- Design pharmacokinetic and drug metabolism studies to be compliant with regulations regarding GLP and GMP, and assure that NeurogesX in accord with FDA, EU and ICH guidelines with respect to required studies.
- Provide extensive input for the drug metabolism and pharmacokinetics sections of regulatory submissions.
- Review the accuracy of regulatory and corporate documents, including INDs, NDAs, Investigator’s Brochures, and clinical and nonclinical protocols and amendments.
Job Requirements:
- Track record in metabolic and pharmacokinetic evaluation of small molecule drugs administered via various delivery routes. Experience with prodrugs and parenteral dosage formulations would be a plus.
- Ph.D., Pharm.D. or similar formal training with at least 6 years of pharmaceutical/drug development experience preferred.
- Willingness and ability to work in an entrepreneurial environment with a “roll up the sleeves” approach.
- Commitment to rapid product development.
- Ability to encourage team attitude within and across functional groups.
- Solid presentation skills.
- Ability to interface professionally with a wide spectrum of internal and external collaborators, including contract research organizations and academicians.
- Willingness to travel as required to supervise studies and select CROs.