Senior Scientist, Translational Research, Cellular Therapy Safety Testing

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Position Summary:

The ideal candidate will be a highly collaborative, organized, and detail-oriented scientist responsible for managing safety testing within the Translational Research department in the Cancer Immunology and Cell Therapy Thematic Research Center.

As a key member of the Translational Research team, the candidate will oversee routine and hypothesis-driven testings to investigate potential safety risks associated with gene-modified cell therapy products in accordance with clinical trial protocols and regulatory guidelines. The scope of work covers early- and late-stage clinical programs and post-marketing settings. The candidate will work with internal and external stakeholders for implementation of the testing, result interpretation, and data reporting across assets. The individual will handle operational tasks related to sample follow-up, testing, data review, and result reporting, and support the interpretation and communication of testing outcomes across programs.

Responsibilities:

• Collaborates effectively with internal and external stakeholders to carry out and deliver results from cell therapy safety testings in alignment with translational strategy and clinical development plan.

• Communicates testing strategy, outcome performance, and milestones to key stakeholders across functions, and engages with technical, scientific, medical, clinical, and operational experts to define, revise, and incorporate testing plans.

• Tracks details associated with patient safety events requiring sample collection, acquisition, and testing in clinical and commercial settings, and ensures timely sample testing and data reporting.

• Critically reviews, analyzes, and interprets test results, draws appropriate conclusions, and leads next-step communication and reporting to internal and external stakeholders in clinical and commercial settings.

• Streamlines and maintains end-to-end processes for safety testing, supports continuing effort on process improvements through cross-functional dialogue and engagement.

• Contributes to responses to inquiries from regulatory authorities or health care professionals on safety testing issues in collaboration with other functional team members.

• Responsible for developing partnerships in a matrix environment, influencing project strategies, and providing expertise in data analysis, reporting and interpretation.

• Must be able to set and understand priorities in a local and fast paced matrixed environment, must be a team player with a collaborative spirit, and capable of building and maintaining networks within and outside the organization.

Basic Qualifications:

• Bachelor’s Degree

  • 7+ years of academic and / or industry experience

Or

• Master’s Degree

  • 5+ years of academic and / or industry experience

Or

• Ph.D. or equivalent advanced degree in the Life Sciences

  • 2+ of academic and / or industry experience

Preferred Qualifications:

• Ph.D. with 2+ years of clinical experience, preferably in the biotechnology or pharmaceutical industry setting, and with demonstrated deep experience in immunology, molecular and cell biology, or cell therapy research.

• Experience establishing strong working relationships with internal stakeholders (e.g. translational, regulatory, clinical, safety, bioanalytical, clinical pharmacology, biostatistics, stats programming, etc.). CRO experience, knowledge of CLIA/GCLP practices is a plus