Pre-Clinical Development SME (Remote)

Hartford, CT

Industry: Regulatory & Scientific Job Number: 146924

Pharmaceutical Pre-Clinical Development Specialist

 

Background: The client is a Pharmaceutical company that is preparing to take an Advanced Therapy Medicinal Product (ATMP) from its Research & Development stage through the Pre-Clinical and Clinical stages, and eventually to a BLA submission. Because it is the first time they’ ve worked with this type of product, they are looking to bring on a Pre-Clinical Development SME to help them navigate through the full Pre-Clinical, Clinical, and Regulatory process.

Project: The consultant will come onto the team and be responsible for guiding the team as they navigate through the process from R&D to BLA submission. The product is an Advanced Therapy Medical Product in Oncology, and the end goal of this project is to submit a BLA submission to get the product to market. This consultant will work with leaders within the Clinical and Regulatory teams to develop a strategy for navigating through the clinical process. This role will involve setting up strategy for characterizing Pharmacokinetics, working on Bioequivalence, safety, and Immunogenicity, and setting up a non-clinical toxicity trial.

Required:

Pharmaceutical Clinical Affairs

Clinical Strategist

Developing Strategy for Pre-Clinical Navigation

Job Type: Contract 

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