Note: The job is a remote job and is open to candidates in USA. Unicon Pharma Inc is seeking an experienced Clinical Scientist and Neurology subject matter expert to support the planning and execution of pivotal clinical studies, including CIDP programs. The role focuses on protocol development, clinical data and endpoint review, risk mitigation, cross-functional collaboration, and regulatory and submission readiness.
Responsibilities
- Support protocol development, feasibility, and pivotal-study planning
- Review endpoint/adjudication materials, clinical data, and protocol deviations
- Identify trial execution risks, operational gaps, and data-quality concerns
- Assess site, vendor, enrollment, monitoring, and patient-retention strategies
- Develop risk-mitigation and corrective action plans
- Collaborate with Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, and vendors
- Support regulatory, inspection, and submission readiness
Skills
- 10+ years of relevant clinical development/clinical research experience with strong neurology and Phase III/pivotal study experience
- CIDP or neuromuscular experience is highly preferred
Benefits
- Remote work arrangement
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