Patient Safety & Pharmacovigilance Global Translational Safety Lead

Job Title: PSPV Global Translational Safety Lead

Location: Cambridge, MA or Morristown, NJ

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. 

Sanofi is an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Advice and guidance based on integrated safety review

• Provide expertise on translational safety science for early development projects to ensure translation of non-clinical and emerging preclinical data into potential clinical risk

• Support Pharmacovigilance teams including Benefit Risk Assessment teams and Translational Safety Expert groups and contribute to the creation and implementation of project-level strategy plan

• Provide expertise on translational patient safety based on biomarkers, precision medicine, and real-world data and contribute to the advancing of pipeline programs

• Contribute to the interpretation of pre-clinical and existing clinical safety data to ensure appropriate use in clinical space

Early and proactive scientific approach to safety

• Lead development of risk management strategic aspects relative to translational toxicology and provide clinical safety input early in candidate programs to ensure opportunities for early mitigation, prevention and characterization of any potential clinical risks are incorporated into non-clinical strategy and clinical study plan

• Develop strategic integrated thinking and streamlined decision making between clinical safety, non-clinical safety, biomarkers genomics and the development teams for the proactive identification, characterization assessment and mitigation of potential toxicities

Education of concerned Stakeholders

• Facilitate the development of translational clinical toxicology expertise to support the design of the early non-clinical proof of concept studies to support excellence in execution and seamless progression between non-clinical and clinical stage of development

• Provide mentorship and expertise to educate and develop scientific capabilities of Global Safety Officers and contribute to Benefit-Risk assessment.

Discovery for access to prospective long-term Patient-level safety data

• Drive innovation and expertise readiness to expand translational safety, including discovery strategy for prospective access and evaluation to patient risk profiling, patient safety experience and clinical data.

• Collaborate within Global Pharmacovigilance for optimizing signal detection, benefit risk assessment and safety reporting, and for ensuring the safe use of our products and working towards a seamless and agile safety system

Promotion of Translational Safety

• Provide translational safety expertise for the development of the Risk Mitigation Plan and structured Benefit Risk Assessment.

• Establish and leverage relationships with key internal and external stakeholders to ensure awareness, understanding, support of translational safety science and translational patient safety and promotion of innovative solutions or initiatives.

About You

Experience & Technical Skills

• A proven and successful track record with at least 5-10+ years of experience in biopharmaceutical clinical development in at least one of the following areas: early development, safety, risk management, pharmacoepidemiology or pharmacovigilance

• In depth and broad knowledge of global Pharmacovigilance regulations, guidelines, and best practices with emphasis on early development regulatory landscape

• Experience working in basic science or clinical development, in one or more of the following domains: gene therapy, cell therapy, biologics, small molecules and medical devices

• Knowledgeable of relevant concepts in healthcare, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics

• Drug development experience spanning the full drug development lifecycle, from target selection, candidate nomination, early and late development

Soft Skills