About the Job

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

The Global Clinical Development Strategy Expert (GCDSE) provides scientific and clinical leadership in the design and development of clinical studies and programmes for Sanofi Pasteur.  They have global responsibility and ownership for the Clinical Strategy, the respective Clinical Development Plans (CDP) and study protocols for projects / programs and ensure that CDPs are written in accordance with the Target Product Profile, IEGP and according to Franchise and Global Project Team strategy.  The GCDSE will assure global consistency across regions.

The GCDSE provides clinical and R&D expertise, guidance and direction in the context of the region/country, in which they operate.

As the leader of the Clinical (or Extended Clinical) Team, the GCDSE is the clinical representative in global project teams (GPT). The GCDSE is a subject matter expert in the disease area of the programs covered. The GCDSE is accountable for and leads the discussion of CDP and relevant study documents including protocol and results with regulatory authorities, other external bodies such as Independent Data Monitoring committees and Advisory Boards; the GCDSE supports other GCDSE colleagues elsewhere for such interactions with similar bodies, if this responsibility is delegated, while assuring global consistency. The GCDSE is also responsible for country / regional / global interactions with regulatory and public health agencies, governments and supranational non-governmental organizations, key opinion leaders and investigators as required.  They also collaborate closely with regional R&D, global medical affairs, and country managers. As such, they have global responsibility and ownership for clinical sections of the Common Technical Document (CTD) as well as for interactions with Regulatory Affairs for pre-submission and submission meetings with Agencies. 

The GCDSE establishes the conditions essential for determining the safety of all subjects involved in Clinical trials for the vaccine development candidates they oversee.  They are also accountable for the ethical integrity of clinical plans, adherence to the highest ethical standards of Clinical trial conduct and adherence to all GCP requirements concerning human subjects. The GCDSE will execute the CDP as close as possible to company optimized timelines. The GCDSE performs medical monitoring activities for studies within the country, region or on a global level as appropriate, addressing any medical questions the site investigative teams have regarding clinical protocols, and monitors study conduct in close collaboration with study management & logistics and Global Pharmacovigilance.

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!