Distinguished Scientist, Safety Assessment Project Expert

Main Responsibilities

• Serve as a Preclinical Safety Project Team Member on multi-functional R&D project teams (small molecules, biotherapeutics, oligonucleotides, and other modalities); develop and implement toxicology and safety pharmacology strategies.
• Support nonclinical safety activities across early-/late-stage development and Life Cycle Management/marketed products.
• Write nonclinical summaries for Investigator Brochures, INDs, CTAs, NDAs/BLAs, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents; review internal/external reports to provide scientific preclinical safety perspective.
• Ensure high scientific standards in conducting and reporting nonclinical safety and investigative toxicology studies; provide leadership with experience interpreting reproductive and developmental toxicity (preferred).
• Provide internal expertise for global nonclinical safety issues for committees/expert groups; prepare publications and presentations.
• Participate in special projects/inter-industry working groups.
• Provide scientific input on R&D study design and analysis, including in-licensing opportunity evaluations.

Qualifications

• PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field; 12+ years pharmaceutical industry experience.
• Demonstrated knowledge of GLP and ICH policies and regulatory nonclinical testing requirements.
• Demonstrated experience preparing and submitting IND and CTD submissions.

Minimum/Preferred Skills

• Experience as a GLP Study Director.
• Experience with ophthalmology toxicity study conduct and interpretation.
• Certification by the American Board of Toxicology.
• Excellent presentation and writing skills.
• English.

Benefits

• At least 14 weeks’ gender-neutral parental leave.