Success Profile

Courageous
Results-driven
Proactive
Problem-Solver
Leadership
Team player

Our Team

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. 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.

Job Description

As an overview, the incumbent will be responsible for oversight of the nonclinical safety program of Research and Development drug candidates primarily in the Development stage. These activities entail formulating the nonclinical safety strategies, designing toxicology studies, authoring regulatory documents, being a member of an integrated Project Team, interacting with internal and external partners, and interactions with global regulatory agencies. Reviewing compounds for potential in-licensing and addressing nonclinical safety issues for marketed products is also an activity. Additional details are:

• 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 Life Cycle Management and marketed products.

• Write nonclinical summaries for clinical Investigator Brochures, INDs, CTAs and NDAs/BLAs, Pediatric Investigation Plans, 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.

• 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 research activities, including evaluations of external opportunities for in-licensing as appropriate, and ensure activities are completed with highest scientific standards.

About you

• Work Experience: Knowledge in biochemistry, toxicology, pharmacology, biology, physiology, pathology, and statistics. 10+ years related pharmaceutical industry experience

• Minimum required skills: Knowledgeable and experienced regarding GLP and ICH policies, regulatory nonclinical testing requirements; Writing documents for regulatory submission and interactions with health authorities. Experienced in conducting and interpreting reproductive and developmental toxicity data is strong desire.

• Minimum preferred skills: experience as a GLP Study Director; Certification by the American Board of Toxicology is preferred but not required.

• Technical skills: Excellent presentation and writing skills

• Education: PhD or DVM

• Language Requirements: English

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.

According to the CDC, an individual is considered to be “fully vaccinated” fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE.

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At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.