Externally Sponsored Research Manager

Sanofi•Morristown, MA

2d•Onsite

About The Position

Within Sanofi, we are committed to supporting medically and scientifically sound research aimed at the advancement of disease knowledge and potential treatments in therapeutic areas of interest to Sanofi with the goal of advancing patient care. Sanofi receives, reviews, and responds to unsolicited proposals from health care professionals (HCPs), scientists, and researchers or institutions (i.e. external sponsor) for Externally Sponsored Research (ESR) support, including Investigator Sponsored Studies (ISS) and Externally Sponsored Collaborations (ESC). The ESR Manager is responsible for operational oversight of unsolicited research support requests submitted through the company web portal, to ensure they are appropriately routed for scientific review. This position will ensure timely and compliant study review, start-up, execution, completion, and tracking of key research milestones as per research agreement, for ESR approved by the Scientific Review Committee (SRC). The role reports directly to the Sanofi Senior Manager, ESR Operations. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions. About Sanofi We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

Bachelor's degree in life sciences or a related scientific discipline
Minimum 2 years of relevant experience in clinical operations, hospital settings, pharmaceutical, or another regulated medical environment

Nice To Haves

Project management experience, certification (e.g., PMP) is a plus
Familiarity with Investigator Sponsored Studies program requirements and the external regulatory environment (e.g., GCP, ICH standards, compliance codes)
Proven track record of driving efficiency in processes
Ability to proactively anticipate obstacles and work independently with minimal direction
Experience managing diverse stakeholders across different functions and seniority levels
Strong verbal and written communication skills
Strong quantitative, analytical, and problem-solving skills
Proven cross-functional collaboration skills across multiple teams and seniority levels

Responsibilities

Manages the overall study operational activities for all ESRs from initial proposal submission to study closeout including (but not limited to) SRC management, tracking ESR performance, supply management, contracting, obtaining regulatory documentation and cross-reference letters, transfer of value reporting, tracking payments, and overall ESR program reporting.
Executes all ESR process-related activities compliantly per Sanofi SOPs, policies & procedures and local laws& regulations.
Contributes to program audit readiness and provides accurate and rapid responses to audit inquiries.
Collaborates cross-functionally to ensure efficient and timely delivery of research agreements, product supply, purchase orders and other deliverables.
Collaborates closely with SRC providing necessary information and support to ensure compliant, timely, efficient reviews of concepts, study outlines, protocols, and protocol amendments.
Supports the development of metrics, KPI’s and other business analytics to measure progress and inform investment decisions; ensures study updates are collected, documented, tracked, and communicated to stakeholders.
Oversees ESR system of record; maintains data integrity by enforcing standards, controls & permissions.
Works with system vendor and Systems & Process Ops team on issue resolution and enhancements.
Collaborates with Product Supply teams to ensure product demand forecasts are maintained and updated to reflect current needs for adequate supply of active studies.
Collaborates and provides information for CMO reporting and cross-GBU initiatives related to ESR.
Supports dissemination of safety updates and Dear Investigator Letters (DILs).
Ensures stakeholders are trained and have access to ESR system of record and other ESR related tools.