Position located in Boston, MA

Responsibilities of the Principal Scientist/Toxicologist:

• Will provide scientific expertise across the drug discovery and development value chain on biotherapeutics and small molecules.
• Provide internal expertise to understand the mechanisms of toxicity, propose solutions for mitigation and back-up strategies.
• Design and direct nonclinical safety studies, including the evaluation and interpretation of safety pharmacology, toxicology, and toxicokinetic information.
• Ability to communicate and execute studies with CRO organization overseas.
• Provide toxicology expertise and strategic guidance to cross-functional project teams and senior management, including toxicology study results and potential impact of toxicology findings on programs.
• Serve as a member of program teams and collaborate with internal and external research partners including preclinical pharmacology, DMPK, and translational sciences to advance drug candidates from discovery to the clinic.

Requirements Principal Scientist/Toxicologist:

• PhD with at least 5+ years experience in developing toxicology programs to support early and later stage drug development.
• Knowledge of relevant ICH & FDA guidance and regulations that are relevant for the strategic planning and conduct of safety studies.
• Demonstrated ability to apply critical thinking to solve complex problems to craft customized preclinical strategies.
• Experience in authoring of preclinical safety section in regulatory filings such as INDs/CTAs.
• Ability to critically evaluate written toxicology documents for overall quality and acceptability of scientific interpretation.