Senior Principal Scientist or Distinguished Scientist - Toxicology
Job Overview and ResponsibilitiesThis position will provide the department of Preclinical Safety a wide range of support associated with Toxicology and Safety Pharmacology needs on Discovery and Development Project Teams of Sanofi Group. This position would provide toxicology scientific expertise across the drug discovery and development value chain on biotherapeutics and small molecules. Activities include, but are not limited to:
Serve as Preclinical Safety project team representative on multi-disciplinary Discovery and Development teams responsible for the progression of both biotherapeutics and small molecule compounds for regulatory submissions. These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program which includes, but is not limited to attending various project team meetings; the design and interpretation of toxicity studies; the preparation and/or review of written safety pharmacology and toxicology reports; and the authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)
Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basis
Participate in issue-resolution teams, where she/he will be required to contribute to hypotheses generation and drive the science for toxicology issue resolution in drug discovery and development.
Participate in Preclinical safety-US and global Preclinical safety Department activities (staff meeting, scientific forums, etc.), and special projects
Participate in special projects or inter-industry working groups, as needed. Provide scientific input on design and analysis of research activities
Serve as internal expert for scientific issues related to nonclinical safety issues
Ensure high scientific standards and adhering to requested timelines in all aspects of the position
DVM or PhD in toxicology, pharmacology, immunology or related disciplines and two years of post-doctoral experience
Knowledgeable and experienced regarding GLP and ICH policies, regulatory nonclinical testing requirements; Writing documents for regulatory submission and interactions with health authorities.
At least 8-10 years of relevant Toxicology experience
Authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)
Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules
Excellent verbal and written communication skills
Demonstrate leadership and expertise in preclinical safety disciplines
The candidate should have knowledge in biochemistry, toxicology, pharmacology, Immunology, physiology, and statistics.
DABT certification is preferred, but not required.
Experience as a GLP Study Director is preferred.
The successful candidate will report to the Head of Preclinical project in the US
This position is based in Cambridge, MA or San Francisco, CA
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.The salary range for this position is 168,039.38 - 224,052.50 to 280,065.63 . All com pensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the link, www.benefits.sanofiusallwell.comAs 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.#GD-SA#LI-SAAt 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.