Job Title : Global Clinical Development Strategy Expert-Vaccines

Location: Swiftwater, PA

About the Job

Within Sanofi Research and Development, and more specifically the Global Clinical Development Department, and within the guidelines given by the Global Clinical Franchise Head, the Global Clinical Development Strategy Expert (GCDSE) is a key member of the Project Team and the Clinical Team. The R&D project team, plans, develops and manages the project strategy, in order to obtain registration of a new product or improvement of a vaccine for the prevention and / or treatment of the disease. The GCDSE is responsible for the clinical development strategy and is thus a core member of the R&D Project team. The Clinical Team is responsible for the execution of the clinical development plan, specifically the clinical studies defined therein. The GCDSE leads the Clinical Team, ensuring that the clinical development strategy is executed according to the adequate processes and with the highest clinical and medical scrutiny.

The candidate will report to the Global Clinical Franchise Head for Pneumo & New Targets and will in principle be responsible for clinical trials in the context of the Acne and New Targets projects. However, at Global Clinical Development we work in a flexible model and the candidate’s responsibility could be extended to other vaccine areas within Sanofi.

The candidate will have a medical degree or a PhD in a life-science area like Biology, Immunology, Pharmacology, etc. Expertise in Infectious Diseases is favorable; immunology, specifically in the clinical development of preventive vaccinology is also favorable. The candidate should have excellent oral and written communication skills in English.

This exciting role will afford candidates the opportunity to be intimately involved in clinical strategy, and all stages of operational clinical development.

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.

Main Responsibilities:

• Define the strategic clinical development plan in line with the global R&D strategy, the specific Franchise (commercial) strategy and the Regulatory needs.

• Present, defend and get endorsement of the clinical strategic plan with the appropriate governance committees within Sanofi Vaccines.

• Support the different functions within the Clinical Team with his/her expertise and leadership (monitoring, data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs) as well as interact with and support Project team members, Clinical Immunology Laboratory, Budget and Planning Functions, Legal and Patent Department, Product Brand Leader and Medical Affairs.

• Ensure that the operational development process is aligned with Sanofi Standard Operation Procedures (SOPs), and help to review and improve current SOPs.

• Manage the clinical development process from early stage development until licensure and provide clinical leadership for the generation of evidence from the clinical development data that will support the licensure and commercialization of the new vaccines (e.g. define evidence generation plan, lead interpretation of clinical data, provide decision-making pathways based on study outcomes, provide risk management analyses and mitigation plans etc) .

• Work closely with the pharmacovigilance department to define and ensure the process of safety surveillance during clinical development and design the safety risk management plan.

• Take the lead for the preparation of key clinical documents to be prepared for clinical trials (protocols, reports), CTD submissions, interactions with Sanofi Pasteur governance bodies, external experts and committees.

• Build and maintain a strong network of internal and external collaborators, opinion leaders, investigators and competent authorities.

• Support the Global Clinical Development department with non-project related activities to continuously improve our way of working, and to maintain our position as center of clinical excellence for Sanofi and with external collaborators.

About You

Key requirements

• Preferred: M.D. with relevant experience or specialization in Infectious Diseases; Paediatrics, Internal Medicine, or PhD with a minimum of 3 years’ experience in Clinical Development.

• A background in clinical immunology is welcome

• Experience with working according to GCP/ICH guidelines

• Excellent interpersonal skills, experience with leading and managing transversal teams

• Ability to work in a diverse environment with different stakeholders

• Considerable degree of autonomy

• Ability to act for change, empower themselves and others.

• Good command of oral and written English.

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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo)

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)