Senior Scientist - Biotransformation and Drug-Drug Interaction Evaluation - Remote

Overview

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.

In Short

• Provide biotransformation and DDI evaluation to enable internal decisions and regulatory filings.
• Manage outsourced biotransformation, transporter, and DDI work to ensure high-quality deliverables of in vitro and in vivo studies.
• Represent EDCP at regulatory meetings and respond to regulatory inquiries related to biotransformation, transporter, and DDI.
• Provide biotransformation and DDI support for regulatory summary documents.
• Provide effective biotransformation and DDI assessment and strategy to address project-related issues.

Requirements

• PhD. with +12 years of experience in biotransformation, transporter, and DDI evaluation in the pharmaceutical industry.
• Demonstrated expertise in biotransformation, transporter, and DDI areas; familiar with FDA’s guidance on DDI evaluations.
• Experience writing and presenting biotransformation and DDI results to regulatory authorities.
• Track record of scientific excellence in biotransformation and DDI assessment, evidenced by publication in scientific journals.
• Excellent interpersonal, organizational, and communication skills.

Benefits

• Comprehensive benefits and competitive compensation packages.
• Flexible work environment.
• Equal opportunity employer.