Neurology Clinical Development Scientist/Director

Key Responsibilities

• Provide clinical and therapeutic-area expertise to support neurology clinical development programs and pivotal studies, particularly in CIDP.
• Provide input into pivotal study planning, execution strategy, and clinical development decisions.
• Serve as a senior Neurology SME and clinical trial advisor, providing independent review and recommendations to the project team.
• Review and provide SME input on clinical trial protocols, adjudication charters, endpoint assessment manuals, and operational plans.
• Assess protocol feasibility and identify challenges related to study design, patient populations, enrollment, retention, and study execution.
• Review study start-up, site activation, patient enrollment, monitoring, and participant-retention strategies.
• Identify clinical trial operational risks, gaps, and potential barriers affecting enrollment, data quality, timelines, or study delivery.
• Review clinical data, protocol deviations, missing data, and emerging study trends to identify clinical or operational quality concerns.
• Provide recommendations for risk mitigation, issue management, and corrective and preventive actions (CAPA), as appropriate.
• Evaluate clinical site and CRO/vendor performance, including roles, responsibilities, escalation processes, and operational accountability.
• Partner with Clinical Development, Clinical Operations, Biometrics, Data Management, Regulatory, Safety, and external vendors/CROs.
• Support regulatory preparation, submission-readiness, and inspection-readiness activities.
• Provide clinical and operational guidance across relevant project teams.

Qualifications

• Advanced degree preferred: MD, PharmD, PhD, or equivalent scientific/clinical background.
• Significant experience in clinical research and/or clinical development within Neurology.
• Strong experience with Phase II/III and preferably pivotal or registrational clinical trials.
• Experience reviewing or developing clinical trial protocols and operational strategies.
• Strong understanding of clinical trial execution, clinical data review, protocol deviations, missing data, enrollment, and patient retention.
• Experience working with CROs, clinical sites, and external vendors.
• Strong understanding of risk identification, mitigation, and issue management in clinical trials.
• Experience working cross-functionally with Clinical Development, Clinical Operations, Biometrics, Regulatory, and Safety teams.
• Excellent analytical, communication, and stakeholder-management skills.

Preferred Qualifications

• Direct experience with CIDP (Chronic Inflammatory Demyelinating Polyneuropathy).
• Experience with Guillain-Barré Syndrome (GBS) or other inflammatory demyelinating neuropathies.
• Experience in neuromuscular disorders, peripheral neuropathy, neuroimmunology, or autoimmune neurological diseases.
• Experience with endpoint adjudication or endpoint assessment committees.
• Experience supporting FDA/EMA submissions, regulatory interactions, or inspection readiness.
• Previous experience as a Neurology Clinical SME, Clinical Development Consultant, Medical Director, or Therapeutic Area Lead.
• Phase III or pivotal clinical trial experience.
• Protocol, endpoint, and clinical data review experience.
• Clinical operations and risk management expertise.