Vx - Global Clinical Immunology Leader - Beiijng
Sanofi Group
**_About the job_**
**Sanofi is recruiting a Global Clinical Immunology leader to support a diverse and growing portfolio of vaccines targeting infectious diseases. This role has provided strategic guidance and operational support for immunogenicity, virologic, and bacterial endpoints in late-stage clinical trials. As a part of the global project team, the successful applicant will contribute to the development of clinical protocols, provide scientific and technical support for regulatory communications and filings, as well as define the strategy for and assays supporting serology, mucosal/ cell mediated immunogenicity, efficacy-supporting diagnostics, and next generation sequencing endpoints for a late-stage program. The successful applicant will operate at an extremely fast pace, working with other global project team members including physicians, regulatory leaders, CMC representatives, discovery scientists, and assay development experts.**
**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:**
**Represent Global Immunology (GI) on the global project team to design** **, execute, and communicate data from clinical trials from multiple late stage programs**
**Scientifically review and provide interpretation** **of both assay development and clinical development data and experimental designs**
**Write / review regulatory documents**
**Support and coordinate all clinical testing activities** **(internal or at 3rd party laboratories) related to Project including communication of resource needs, assisting Lab Coordinators with scheduling for routine testing and with the Scientists/Lead technicians for test development or troubleshooting by providing the necessary scientific expertise**
**Lead and influence evaluation and improvement of new/existing technologies; ensure the development and** **qualification/validation** **of robust immunologic, virologic, and bacteriologic assays that meet ICH guidelines to support clinical studies**
**Serve as function representative and SME at key strategic internal/external meetings,** **conferences/congresses,** **and key meetings with CROs and with regulatory authorities.**
**Act as a contributing author to high-quality publications describing assay development and/or the immunogenicity and efficacy of candidate and approved drugs in technical, medical, or scientific journals**
**_About you_**
**Experience** **: 10 years post-MS or 4 years post-PhD experience, preferably with experience contributing to translational or interventional clinical studies**
**Skills** **:**
**Entrepreneurial mindset with positive energy and strong sense of determination**
**Proven leadership, verbal and written communication, organizational and team management skills**
**Proven ability to develop and implement new procedures/processes. Familiarity with laboratory testing regulations both internally and externally (CROs) is a plus.**
**Project management and computer skills required**
**Record of innovation as evidenced by a strong publication record, inventorship on patents/filings and presentations at major conferences**
**Education** **:** **_MS, or PhD in Virology, Bacteriology, Immunology, Molecular Biology, Microbiology, Cell Biology, or other relevant scientific fields_**
**Languages** **: English Fluent**
**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) !
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)
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