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 Clinical Study Unit (CSU) is the site facing arm of clinical operations that is responsible for monitoring and enrolling patients into our clinical studies here at Sanofi. The individual CSUs are organized into countries or clusters and generally include a Country/Cluster Head (CH), Medical Advisors (MDA), Team Leaders (TLs), Local Study Managers (LSM), Site Engagement Leads, Local Innovation Leads, and a Monitoring Team.

Clinical Study Units (CSUs) are our experts with deep knowledge and know-how of clinical trial delivery in our key strategic countries and are one of the closest links to our clinical investigators and patients, setting up the company studies within each relevant country, and delivering quality data, as much as maintaining site and patient engagement in the longer term.

We are 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:

Site Engagement Leads (SELs) will:

• Ensure that the needs of appropriate investigational sites, to meet patient recruitment and DE&I targets, are considered locally during the early planning phase for Sanofi's clinical trials.

• Most important Plan country-level site strategy by proactively aligning country site engagement activity with Sanofi's Clinical Trial engagement strategy and current and upcoming clinical development programs.

• Actively engage with investigational sites in all stages of clinical trial development activities from protocol development through to study completion, and across multiple programs, thus contributing to accelerated and more efficient clinical development of Sanofi compounds through improved site performance (reduced timelines, increased number of patients enrolled, and better quality of study delivery).

• Drive and oversee the engagement strategy of all investigational sites for the CSU, adapting the level of personal SEL engagement in accordance with the mutual benefit agreement of the Collaborative, MedDev Synergy, and OneSanofi strategies.

• Be accountable for the clinical trial delivery (across studies) and implementation of innovative digital solutions at all sites.

• Provide transversal collaboration by supporting early planning activities, optimizing clinical trial operations, improving site engagement, and anticipating upcoming studies through stronger communication between the sites and Sanofi, and contributing to effective patient recruitment and retention plans at a local level.

• Proactively assess improvement opportunities for the site engagement strategy, understand project needs and propose solutions to accelerate clinical trial development activities and improve site performance. Foster relationships with sites, even in complex environments.

Per the United States strategy, the SEL role is structured around four key pillars: Site Identification, Bridging, External Engagements, and Collaborative Relationship Building. These pillars guide the SEL's activities and responsibilities within the USCSU.

Focused Responsibilities:

Patient Stakeholder Strategies:

• Leverage cross-functional Integrated Patient Engagement frameworks to deliver a patient-centric approach for US clinical trials, including an integrated patient and site identification strategy.

• Contribute to the R&D elements of the Patient Community Charter (https://www.sanofi.com/assets/dotcom/content-app/articles/your-health/patient-community-charter/sanofi-patient-charter-2023.pdf ).

• Establish effective patient and site advisory boards to achieve efficiencies in the conduct of clinical trials and inform programs ahead of protocol concept through to protocol execution.

• Increase the visibility with trial sites and PAGs about how Sanofi's pipeline is differentiated from a patient perspective.

• Demonstrate the value of earlier patient stakeholder collaborations (e.g., use of registries, connections with patient support programs sponsored by Medical that can also act as clinical trial awareness and health screening events for study participation).

• Enhance and leverage closer collaboration between Medical and Development (evaluate study collaboration metrics, e.g., reduced number of inactive sites, faster time from protocol to FPI) to support GROW US goals, increasing trial enrolment to 30%.

US Site Identification:

• Serve as an expert in evidence-based site selection and operational feasibility execution.

• Utilize data-driven approaches to identify and select investigational sites capable of meeting recruitment goals and delivering high-quality data.

• Ensure 120% of required sites are identified by the end of the Operational Feasibility phase.

• Assess the operational feasibility of sites, ensuring they have the necessary resources and infrastructure to conduct clinical trials effectively.

• Develop and implement a country-level site engagement strategy that aligns with current and upcoming clinical development programs.

Bridging:

• Act as a bridge between Medical and Development teams to support clinical trial delivery.

• Foster closer collaboration to enhance study execution and improve patient recruitment and retention.

• Support ambitious US recruitment goals by contributing to increasing trial enrolment through collaborative strategies and operational efficiencies.

• Evaluate and improve study collaboration metrics, such as reducing the number of inactive sites and accelerating the time from protocol to first patient in (FPI).

• Serve as a connection point for Early Operations (EOR), Local Medical Expert Committee (LMEC), Operational Feasibility (OF), Site Initiation Visit/Site Selection Visit (SIV/SSV) Strategy, and Recruitment & Retention (R&R) strategy.

Community-Based Programs:

• Work closely with PID&HVT and the DICT team to build effective and sustainable community-based programs that demonstrate improvements in achieving diverse enrollment and high rates of retention.

• Ensure the review of the Engagement Strategy Plan (global) with local Medical and Public Affairs; local IPE action plan agreed upon by CSU-MA-PA.

External Communications & Engagements:

• Participate in external communications that support the brand awareness of the integrated patient engagement priorities within Sanofi's clinical trials (e.g., conference presentations, posters, publications, etc).

• Contribute to the patient disease strategy and integrated patient journey to reflect the US patient experience.

About You

Experience

• Proven track record in clinical research, site management, or related field

• Experience in building and maintaining relationships with key opinion leaders (KOLs) and investigational sites

• Demonstrated success in implementing patient engagement strategies in clinical trials

• Track record of contributing to diverse enrollment and high retention rates in clinical studies

Soft skills

• Advanced Emotional Intelligence/ATL (Play2Win): Ability to integrate emotional awareness, self-management, and social skills in daily activities to manage relationships effectively

• Advanced Interpersonal & Relationship Management Skills: Influence, inspire, and encourage people to think in a certain direction without force while acknowledging their opinions

• Advanced Change Management Skills: Reinforce change by supporting others

• Leadership qualities, including:

  • Setting clear performance expectations

  • Giving and receiving effective feedback, including conducting challenging conversations

  • Coaching individuals toward improved performance

  • Motivating others, implying team engagement and retention

  • Adapting leadership style

Technical skills:

• Advanced Clinical Development Process Skills: Understanding of the governance that guides Sanofi clinical development strategy

• Advanced Problem-Solving Skills: Ability to apply critical thinking to strategize ways of solving problems

• Advanced Project Management Skills: Application of continuous improvement methodology/tools

• Intermediate Risk Management Skills: Proactively measure & assess/map risk triggers (Risks-Probability-Impact): Threats & Opportunities

• Intermediate Medical / Scientific Background - TA / Disease Knowledge: Understanding of diseases, diagnoses, therapeutic options, and competitive environment

• Intermediate Data Analytics (& Digital) Skills: Ability to use data-driven strategies as a key element in leadership and management tasks

• Advanced Business Acumen: Ability to develop functional plans with strategic goals, short-term and long-term planning. Prioritize team needs to make an impact on the business. Think OneSanofi (External), think Sanofi First (Internal), keep Sanofi and Sanofi R&D strategic goals, growth, and profitability drivers in mind

• Strong understanding of the U.S. healthcare system and clinical trial landscape

• Proficiency in data analysis and interpretation, with the ability to use data-driven approaches for site selection and engagement

Education: (not mandatory)

• BS, MPH, MBA, or similar

Languages:

• Fluency in English (written and spoken) required

• Additional languages beneficial but not required

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 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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Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t 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, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.