Job Title: Principal Scientist I, Non-Clinical Study Manager

Location: Cambridge, MA

About the Job

Are you ready to shape the future of medicine? 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.

The Non-Clinical Study Manager (NCSM) will manage the outsourcing operations for preclinical safety (PCS) studies to CRO sites in different countries worldwide enabling the transition of a R&D project from entry into development up to and beyond NDA submission. Outsourcing management includes business relevant processes from the CRO sourcing to study reporting like requesting quotes, launching purchase orders, engaging with procurement and legal as required. In close collaboration with the Sanofi project team member and multiple internal stakeholders, the NCSM oversees the initiation, progression and quality of operations at the vendor under strict adherence to scientific project team objectives, project strategy and time axis as well as the scientific review of external data and documents.

• Work collaboratively with internal and external cross-functional teams or stakeholders to manage all non-GLP and GLP-outsourced part of preclinical safety studies enabling progression of R&D projects (general toxicology, reproductive toxicology, genetic toxicology, safety pharmacology, phototoxicity, juvenile toxicology...) in respect to timelines, budget, and quality deliverables.
  
• As key contact between Sanofi Project Team and Contract Research Organizations (CROs) ensure all aspects necessary for contracting studies: CRO sourcing, Statement of Work (SOW), quotes, invoice management, assistance schedule maintenance, obtaining approved AEDs, POs and legal contracts (Master Service Agreements/Confidentiality Agreements), CRO performance and scientific monitoring (study documentation and review of data interpretation).
  
• Monitor studies for their progress and quality related to the scientific integrity / collaborate with GLP Site Quality Operations and Animal Welfare to perform study (as required) or site audits.
  
• Review and finalize nonclinical study protocols, amendments, and reports, ensuring that documents meet project timelines, expectations, and deliverables.
  
• Engage Sanofi preclinical safety expert/advisors as appropriate (safety pharmacologist, pathologist, genetic or reproductive toxicologist, biomarker expert...) to maximize the quality of scientific evaluation and interpretation and resolve issues as required.
  
• Facilitate regular communication between project team members, the CROs and planning partners.
  
• Occasional travel at CROs to monitor outsourced studies.
  

• Bachelors degree in scientific-related field with a minimum of 10 years of experience in toxicology and/or safety pharmacology (as study director, outsourcing manager or operations manager) or a Master's degree with a minimum of 7 years of experience of a PhD with a minimum of 5 years of experience
  
• Good knowledge of pharmacokinetics, statistics or related fields with a broader understanding of in vivo biological systems would be a plus.
  
• Good understanding of the broad landscape of CROs and other partnerships involved in conducting preclinical studies.
  
• Familiar with quality regulations (GLP policies), animal welfare and preclinical testing requirements
  
• Knowledge in study and/or project management
  
• High degree of self-organization, flexibility, attention to details, agility, pro & reactive attitude, ease to collaborate transversally with Sanofi groups (i.e. project team member of different functions having scientific stakes in the studies, procurement, scientific advisors, global planning, others) and CROs (Key account contact, study directors, others).
  
• Demonstrated a team player attitude in a fast-paced environment and takes the initiative to identify, analyze and resolve issues.
  
• Ability to sustain high levels of performance in a constantly changing environment.
  
• Excellent communication and presentation skills.
  

• Bring the miracles of science to life alongside a supportive, future-focused team.
  
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
  
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
  
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.