Distinguished Scientist, Safety Assessment Project Expert

Role Summary

Distinguished Scientist, Safety Assessment Project Expert will oversee the nonclinical safety program for Research and Development drug candidates, formulating safety strategies, and designing safety pharmacology and toxicology studies. The role includes authoring regulatory documents, leading scientific interpretation, and coordinating with internal and external partners to support regulatory interactions and safe product development. The incumbent will also review potential in-licensing opportunities and address nonclinical safety issues for marketed products. Location: Cambridge, MA (hybrid: 3 days onsite).

Responsibilities

• Oversee the nonclinical safety program for Research and Development drug candidates, formulating nonclinical safety strategies, designing safety pharmacology and toxicology studies, authoring regulatory documents, and interacting with internal and external partners and global regulatory agencies. Review compounds for potential in-licensing opportunities and address nonclinical safety issues/risks for marketed products.
• Serve as a Preclinical Safety Project Team Member (PTM) on multi-functional Research and Development Project Teams for small molecules, biotherapeutics, oligonucleotides, and other modalities; support the development of new products, develop and implement toxicology and safety pharmacology strategies; support needed nonclinical safety activities for early-/late-stage development and Life Cycle Management/marketed products.
• Write nonclinical summaries for clinical Investigator Brochures, INDs, CTAs and NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents; review reports and other documentation authored by internal personnel and/or external contract laboratories to provide the appropriate preclinical safety scientific perspective.
• Ensure high scientific standards in conducting and reporting nonclinical safety and investigative toxicology studies; provide scientific leadership within Preclinical Safety, particularly with experience in the conduct and interpretation of reproductive and developmental toxicity studies and data (preferred).
• Provide internal expertise for global nonclinical safety issues on various expert groups or internal committees as required; prepare scientific publications and presentations from toxicology and safety pharmacology studies as appropriate; 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 opportunities for in-licensing, and ensure activities are completed with highest scientific standards.

Qualifications

• Required: PhD or DVM with at least 12-15+ years related pharmaceutical industry experience; knowledge in biochemistry, toxicology, pharmacology, biology, physiology, pathology, and statistics.
• Required: Knowledgeable and experienced regarding GLP and ICH policies, regulatory nonclinical testing requirements; writing documents for regulatory submission and interactions with health authorities. Experience in IND and CTD submissions desired.
• Preferred: Experience in cell and gene therapy studies and data.
• Preferred: GLP Study Director experience.
• Preferred: Certification by the American Board of Toxicology.
• Language: Required: English.

Education

• PhD or DVM in a relevant field (e.g., biochemistry, toxicology, pharmacology, biology, physiology, pathology, or related discipline).

Skills

• Excellent presentation and writing skills.