Distinguished Scientist, Safety Assessment Project Expert

Role Summary

Distinguished Scientist, Nonclinical Safety Project Expert. Location: Morristown, NJ or Cambridge, MA. Responsible for oversight of the nonclinical safety program within Research and Development, formulating safety strategies, designing studies, authoring regulatory documents, and coordinating with global partners and regulatory agencies.

Responsibilities

• Serve as a Preclinical Safety Project Team Member on multi-functional R&D Project Teams for various modalities. Develop and implement toxicology and safety pharmacology strategies; support nonclinical safety activities across development stages and for marketed products.
• Write nonclinical summaries for regulatory documents (INV Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigations, Scientific Advice) and review related internal or external documentation to provide preclinical safety perspective.
• Ensure high scientific standards in nonclinical safety and investigative toxicology studies; provide leadership within Preclinical Safety, with preferred experience in reproductive and developmental toxicity.
• Provide internal expertise on global nonclinical safety issues; prepare publications and presentations from toxicology and safety pharmacology studies.
• Participate in special projects or industry groups as needed; provide input on R&D design and analysis, including external licensing opportunities.

Qualifications

• Minimum required: Knowledge of GLP and ICH policies, regulatory nonclinical testing requirements; experience writing regulatory submissions and interacting with health authorities. IND and CTD submissions desired. Experience in cell and gene therapy studies is preferred but not required.
• Minimum preferred: experience as a GLP Study Director. Certification by the American Board of Toxicology is preferred but not required.
• Technical: Excellent presentation and writing skills
• Education: PhD or DVM
• Language: English

Skills

• Strong scientific input on design and analysis of R&D activities; ability to evaluate external licensing opportunities and maintain high scientific standards.
• Ability to lead and collaborate within cross-functional teams and global partner networks.

Education

• PhD or DVM

Additional Requirements

• Location: Morristown, NJ or Cambridge, MA
• Travel: Not specified in source