Clinical Scientist Consultant​/Neurology SME; Remote Part time

Clinical Scientist Consultant / Neurology SME (100% Remote)

Our client, a world leader in biotechnology and life sciences, is looking for a Clinical Scientist Consultant / Neurology SME to provide scientific and clinical expertise supporting the planning and execution of pivotal neurology clinical programs.

Key Responsibilities:

• Provide clinical SME guidance for neurology clinical trials, including pivotal studies.
• Review and provide input on protocols, endpoints, adjudication charters, endpoint assessment manuals, and clinical study plans.
• Identify clinical trial risks, operational gaps, enrollment challenges, data-quality concerns, and protocol issues and recommend mitigation strategies.
• Assess site performance, patient enrollment/retention, monitoring, vendor oversight, and overall study execution.
• Review clinical trial data, including protocol deviations, missing data, emerging trends, and data-quality issues.
• Partner cross-functionally with Clinical Development, Clinical Operations, Biometrics, Regulatory, Safety, and external vendors.
• Support pivotal-study and regulatory readiness activities.

Required Qualifications:

• Strong experience in neurology clinical trials, preferably pivotal Phase 2/3 studies.
• Senior-level experience as a Clinical Scientist, Clinical Development Scientist/Lead, or similar clinical development role.
• Hands-on experience with protocol development/review, clinical endpoints, and clinical trial data.
• Ability to assess study risks and provide scientifically sound recommendations and mitigation strategies.
• Understanding of clinical trial operations, including sites, enrollment, monitoring, vendors, and data quality.

Preferred:

• CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) or related neuromuscular/neurology experience.
• Experience with endpoint adjudication.
• Regulatory submission/readiness experience.
• Experience supporting cross-functional pivotal clinical programs.

If interested, please send us your updated resume at  /