Deputy Director / Global Immunology Project Team Member - Vaccine
Swiftwater, Pennsylvania, Marcy-l'Étoile, France
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The Deputy Director / Project Representative is responsible to manage the completion of the project, developing strategy and planning, helping to assign tasks and monitoring overall progress. Key responsibilities will be to manage the Clinical Immunology testing deliverables for new product development, registration extensions, and project related technology interactions with internal collaborators, as well as external groups including key opinion leaders.
To demonstrate all applicable competencies and behaviors including strategic thinking, high commitment to customers, ability to cooperate transversally across multiple functions, to act for change while continually striving for targeted results. The Deputy Director / Project Representative must be able to demonstrate leadership skills, act as a role model to the team and promote good communication and teamwork within the scientific team.
Assist Project Leaders in the management of the successive development stages of their project by actively providing expertise in Clinical Immunology necessary to - for example - go through the various Project Reviews and Project Stage Gate process, perform Risk Assessment, write / review regulatory documents such as INDs, CTDs, Clinical Trial Protocols, CSRs, and e-BLA sections.Appropriately support interactions with external experts and key opinion leaders.If required, lead efforts to develop laboratory testing in external laboratories, which may involve in technology improvements and transfers.
Appropriately relay information from Project Teams/Sub-Teams to Global Immunology function with regards to PKMs, sub-milestones, project/product strategy and priorities within the project.
Actively participate within the GI function in the yearly project budget and projections (activities and timing) to ensure that realistic information is provided to R&D Senior Management by the Project Leaders.If required for assigned projects, manage external contracts and grants.
Support and coordinate all GI activities (internal or sub-contracted) related to his/her Project(s) in partnership with the Platform Leaders for scheduling and resource needs, with the Lab Coordinators for routine testing and with the Scientists/Lead technicians for test development or troubleshooting by providing the necessary scientific expertise
Be capable if required to support laboratories by reviewing data and experimental designs
Ensures adherence to all applicable quality, corporate, safety, and regulatory requirements.
Area of Influence/Impact:
Serve as function representative and SME at key strategic internal/external meetings, conferences/congresses, and key meetings with CROs and with regulatory authorities.
Generate scientific papers for publication/presentation.
Lead and influence evaluation and improvement of new/existing technologies.
Provide strategic and technical/scientific input to support cross-functional team objectives.
Partner/collaborate with internal/ external scientists to ensure completion of key deliverables.
As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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