Distinguished Scientist, Safety Assessment Project Expert

Main responsibilities

• Serve as a Preclinical Safety Project Team Member (PTM) on multi-functional Research and Development Project Teams on 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 and or assist other PTMs in such activities as needed.
• Review reports and other documentation authored by internal personnel (e.g. Preclinical Safety, other Project Team functions) and/or external contract laboratories to provide the appropriate preclinical safety scientific perspective.
• Ensure high scientific standards in conducting and reporting of 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.

About you

• PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, pathology, statistics, or related field, with 12+ years of pharmaceutical industry experience.
• Demonstrated knowledge and experience regarding GLP and ICH policies and understanding of regulatory nonclinical testing requirements.
• Demonstrated experience in preparing and submitting IND and CTD submissions.
• Experience as a GLP Study Director.
• Experience in the conduct and interpretation of ophthalmology toxicity studies and data.
• Certification by the American Board of Toxicology.
• Excellent presentation and writing skills.