Clinical Scientist Consultant / Neurology SME (100% Remote)” – Part time

Dawar Consulting•San Mateo, CA

3d•Remote

About The Position

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. This is a long-term contract position with the possibility of extension.

Requirements

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.

Nice To Haves

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.

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.