Clinical Scientist Consultant – Neurology SME

This is a fully remote position, open to applicants in California.

📋 Description

• Offer expert clinical guidance as a Subject Matter Expert (SME) for neurology clinical trials, including critical studies.

• Evaluate and contribute to the development of protocols, endpoints, adjudication charters, endpoint assessment manuals, and clinical study plans.

• Identify potential risks in clinical trials, operational deficiencies, challenges in enrollment, data quality issues, and protocol-related problems, and suggest appropriate mitigation strategies.

• Analyze site performance, patient enrollment and retention, monitoring processes, vendor management, and the overall execution of studies.

• Examine clinical trial data, focusing on protocol deviations, absent data, emerging trends, and data quality concerns.

• Collaborate across various functions including Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, and external vendors.

• Assist in activities related to pivotal studies and regulatory readiness.

⛳️ Requirements

• Extensive experience in neurology clinical trials, particularly in pivotal Phase 2/3 studies.

• Senior-level expertise as a Clinical Scientist, Clinical Development Scientist/Lead, or in a comparable clinical development position.

• Practical experience with protocol development and review, clinical endpoints, and clinical trial data management.

• Capacity to evaluate study risks and offer scientifically valid recommendations and mitigation strategies.

• Comprehensive understanding of clinical trial operations, encompassing sites, enrollment, monitoring, vendor interactions, and data quality management.

• Preferred experience with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) or related neuromuscular/neurology fields.

• Familiarity with endpoint adjudication is advantageous.

• Experience in regulatory submission and readiness is preferred.

• Background in supporting cross-functional pivotal clinical programs is preferred.

🏝️ Benefits

• Medical coverage.

• Paid sick leave.

• 401K plan.