Associate Director Clinical Research & Development
T
The Judge Group
📍 Parsippany-Troy Hills, New Jersey, United States
Job Description
Our client is currently seeking an Associate Director Clinical Research & Development
This job will have the following responsibilities:Assess viability of 505(b)(2) and complex generics ideas from Clinical R&D perspective. Act as an independent clinical pharmacologist to identify required studies per the regulatory strategy, and to design and execute such studies. Responsible for providing clinical expertise pertaining to study design, planning and execution of Phase 1, Phase 2 or Phase 3 clinical studies. Ensures each project has a robust PK and clinical program and adheres to GCP, GLP and all applicable regulatory guidelines. Monitor changes/updates made to Guidance documents related to Clinical studies/BE studies and implementation thereof. Identify gaps in pre-clinical and Phase 1 DDP that could impact Phase 2/3 design and execution timelines for company internal projects as well as programs being evaluated as part o...
This job will have the following responsibilities: