Senior Clinical Scientist [Contract]
Core
Senior Clinical Scientist supporting Clinical Development plans and Medical Directors for tumor infiltrating lymphocyte (TIL) therapy assets.
Role type
Senior Clinical Scientist (Oncology/Cell Therapy)
Builds
Clinical study documents, regulatory submissions, and clinical development plans for cancer therapies.
Domain
Biotechnology / Oncology / Cell Therapy
Deliverable
client delivery
Required skills
Clinical study design, GCP/ICH compliance, data monitoring and cleaning, regulatory submission writing, data listing review, cross-functional collaboration, project management
Preferred skills
Cell therapy experience, Spotfire proficiency, melanoma/sarcoma therapy knowledge, CRO/vendor management, Phase I-III trial experience
Technologies
Spotfire, Microsoft Office Suite
Responsibilities
Design and write clinical protocols and study documents; serve as expert on clinical study design and develop training materials; provide medical monitoring support or oversight of CRO activities; collaborate on writing clinical sections of regulatory submissions; support clinical development planning via data evaluation; maintain awareness of scientific and regulatory developments.
Seniority
Senior, hands-on IC
