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

·       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.

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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.

• Project management and computer skills required

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• Education: MS, or PhD in Virology, Bacteriology, Immunology, Molecular Biology, Microbiology, Cell Biology, or other relevant scientific fields

• Languages: English Fluent