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 of Research and Development drug candidates, formulating safety strategies, designing studies, authoring regulatory documents, and interacting with partners and global regulators.

Responsibilities

• Serve as a Preclinical Safety Project Team Member on multi-functional R&D Project Teams across modalities. Develop and implement toxicology and safety pharmacology strategies; support nonclinical safety activities for early-/late-stage development and Life Cycle Management/marketed products.
• Write nonclinical summaries for regulatory documents (clinical Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice) and assist other PTMs; review internal and external documentation to provide preclinical safety perspective.
• Ensure high scientific standards in conducting and reporting nonclinical safety and investigative toxicology studies; provide scientific leadership with emphasis on reproductive and developmental toxicity (preferred).
• Provide internal expertise on global nonclinical safety issues; prepare scientific publications and presentations from toxicology and safety pharmacology studies.
• Participate in special projects or inter-industry working groups as needed.
• Provide scientific input on design and analysis of R&D activities, including evaluations of external in-licensing opportunities; ensure high scientific standards in activities.

Qualifications

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

Skills

• Scientific input on design and analysis of R&D activities; evaluating external opportunities for in-licensing; maintain highest scientific standards.

Education

• PhD or DVM

Additional Requirements

• None beyond those listed above.