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
Work Experience:
- PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, or closely related field, with 12+ years of pharmaceutical industry experience in drug development and demonstrated experience in preclinical safety and toxicology.
- 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.
- Exceptional communication (written and verbal) and presentation skills with ability to present preclinical safety data in a project team setting and/or HA interactions.
Minimum preferred skills:
- Experience as a GLP Study Director and/or Study Monitor.
- Experience in the conduct and interpretation of ophthalmology toxicity studies and data.
- Certification by the American Board of Toxicology is preferred but not required.
Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, lets be those people.
Sanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.
North America Applicants Only
The salary range for this position is:
$178,500.00 - $257,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information canbe found here.
