Senior Manager leading Clinical Laboratory Study Management for Regeneron, engaging in precision medicine operational execution and team leadership.
Responsibilities
Lead and develop a team of Clinical Laboratory Study managers (CLSM) for various therapeutic areas including Immuno-Oncology (IO)
Key driver of precision medicine operational execution partnering with various teams to deliver high-quality samples and data
Participate in cross-functional study teams and sub-teams across clinical and research departments
Works with project manager and set-up manager of central/specialty lab and clinical study team to build lab database to address clinical trial sample collection needs, kits, testing and logistics
Monitor acquisition of clinical trial samples and ensure compliance with ICF permissions
Supports clinical study teams for technical and operational sample-related matters
Manages FSP CLSM team for technical and operational support on their assigned therapeutic program and studies.
Requirements
Bachelors degree
Minimum of 8 years pharmaceutical experience in matrix interaction preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams
Minimum of 5 years’ experience with Clinical Trials, focus on clinical sample collection.
Extensive experience in Clinical laboratory operations, biospecimen logistics, and/or clinical study experience requested.
Strong understanding of technical, clinical, and strategic aspects of laboratory operations delivery required.
Clinical study knowledge, demonstrated by knowledge in science and technology.
Demonstrated experience in stake holder management, leading internal and external meetings and solutioning skills.
Benefits
health and wellness programs (including medical, dental, vision, life, and disability insurance)
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