Distinguished Scientist, Safety Assessment Project Expert

Sanofi•Cambridge, MA

4d•$178,500 - $257,833•Onsite

About The Position

The candidate will be part of a dynamic interactive Preclinical Safety group that spans all aspects of the drug development value chain providing toxicology and safety pharmacology expertise as a member of global project teams. Given the activities performed by the group, internal (within Preclinical Safety and with other project functions) and external (collaboration partners) interactions occur on a daily basis making for a diverse work environment. You will Be exposed to all aspects of the drug development chain Have diverse opportunities to provide toxicology scientific input and apply those expertise Be recognized by Management and Project Teams for successes Receive excellent benefits and compensation. As an overview, the incumbent will be responsible for oversight of the nonclinical safety program of Research and Development drug candidates. These activities entail formulating the nonclinical safety strategies, designing safety pharmacology and toxicology studies, authoring regulatory documents, being a member of an integrated Project Team, interacting with internal and external partners, and interacting with and responding to global regulatory agencies. In addition, you will review compounds for potential in-licensing opportunities and address nonclinical safety issues/risks for marketed products as other activities. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. Are you ready to shape the future of medicine with us? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our safety team as a toxicologist and you’ll assure the safety, quality, purity and stability of Sanofi components and products, while enjoying lots of opportunities to broaden your experience and hone your skills.

Requirements

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.
Excellent presentation and writing skills
English language proficiency

Nice To Haves

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

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.