Job description
NovaCure Medical Institute is seeking a Senior Clinical Research Scientist to lead transformative trials in Specialized Medicine. This is a strategic, hands-on role focused on rare diseases and precision therapies, combining scientific excellence with practical execution to improve patient outcomes.
In this position you will design robust study protocols, oversee regulatory submissions, ensure rigorous data integrity, and mentor cross-functional teams. You will collaborate with Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs to deliver high-impact results across diverse therapeutic areas.
We offer a collaborative, patient-centric environment, competitive compensation, comprehensive benefits, and ample opportunities for professional growth.
Responsibility
- Lead design, execution, and oversight of early- and late-phase clinical trials in Specialized Medicine, including protocol development and study governance.
- Coordinate regulatory submissions, IRB/ethics approvals, and safety reporting in collaboration with Regulatory Affairs and Pharmacovigilance.
- Develop comprehensive study materials, including protocols, informed consent forms, case report forms, and data management plans.
- Partner with Clinical Operations, Biostatistics, Medical Writing, and Data Science to ensure high-quality data and timely deliverables.
- Oversee vendor selection, budgets, timelines, and vendor performance to ensure project efficiency and compliance.
- Monitor safety data, conduct interim analyses, and contribute to DSMBs as needed.
- Mentor junior scientists, foster continuous learning, and contribute to scientific publications and conference presentations.
Qualification
- PhD or MD in Biomedical Science, Medicine, Pharmacology, or a related field; or equivalent clinical research experience in Specialized Medicine.
- Minimum 5 years of clinical research experience, with a track record in rare diseases or precision medicine.
- Strong knowledge of ICH-GCP, FDA/EMA regulations, IRB processes, and regulatory documentation.
- Experience with protocol development, statistical analysis plans, and data analysis (SAS, R, or Python).
- Proficiency with electronic data capture (EDC) systems, CTMS, and data management workflows.
- Excellent scientific writing and communication skills; proven ability to lead cross-functional teams and present complex data clearly.
- Willingness to travel up to 20-25% and work in a dynamic, fast-paced environment.