Externally Sponsored Research Manager

Job Title : Externally Sponsored Research Manager

Location : Cambridge, MA Morristown, NJ

About the Job

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.

Main 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 informinvestment 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 R&D and Local Product Supply teams to ensure product demand forecasts are maintainedand 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.

About You

QUALIFICATIONS

Minimum of 3 years of relevant experience in Medical, regulated pharmaceutical environment, or other relevant experience.

Bachelor’s education at minimum.

Project management experience, certification preferred.

Knowledge of Medical Investigator Sponsored Studies program requirements and understanding of the external environment and regulations that impact the conduct of such programs, including GCP, ICH standards, OIG, PhRMA code, etc. preferred.

Strong quantitative, analytical (technical and business) and problem-solving skills.

Strong verbal and written communication skills; proven cross-functional collaboration skill and experience.

Proven self-starter with experience driving efficiency in processes highly desirable.

CORE COMPETENCIES

Stretch – to go beyond the level we have operated at up until now :

Constantly challenges the status quo to achieve better outcomes

Focuses on priorities that deliver the best outcomes and stops activities that won’t

Strives for excellence; does not tolerate mediocrity

Take Action – instead of waiting to be told what to do :

Takes smart and informed risks based on available information, even if it is not 100% complete

Makes bold and impactful decisions to move us forward

Focuses on what we can constructively do in any situation, despite the constraints

Constantly asks how we can take action without waiting for direction

Act for Change – embrace change and innovation by supporting the evolution of the ESR Operations function, driving improved effectiveness.

Cooperate Transversally – collaborate effectively with peers, stakeholders and partners across the organization to positively impact ESR program efficiency and execution.

Strategic Thinking & Decision Making – ability to think broadly and long-term to drive excellence in execution and timely decision making based on information available to support compliant and efficient delivery of study milestones.

Develop People – take responsibility for self-development to improve performance and positive impact to the organization along with driving individual career progress.

Commit to Customers – Understand, meet and excel internal and external customer expectations to create positive impact through the evolution of the ESR Operations function.

Why Choose Us?

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 a 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.

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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.