COMPLETE Senior Principal Scientist, Toxicology - Cambridge

Senior Principal Scientist, Preclinical Safety Projects, US

Job Overview and Responsibilities:

This 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 

Basic Qualifications:

• PhD in toxicology, pharmacology, immunology or related disciplines and two years of post-doctoral experience

• At least 5-8 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

Preferred Qualifications:

• 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. 

Location Information:

• The successful candidate will report to the Head of Preclinical project in the US

• This position is based in Cambridge, MA.

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.

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