The Role

The company is seeking a senior Clinical Scientist / Neurology Subject Matter Expert (SME) to provide strategic clinical and operational support for neurology clinical development programs and pivotal studies, with a particular focus on Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and related inflammatory demyelinating disorders, including Guillain-Barré Syndrome (GBS).

The ideal candidate will bring significant experience in neurology clinical trials, clinical development, protocol review, pivotal and Phase III studies, clinical data assessment, and clinical trial risk management. Direct experience with CIDP, GBS, peripheral neuropathy, or other neuromuscular and inflammatory neurological disorders is highly preferred.

Key Responsibilities

Clinical Development & Study Strategy

• 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.

Protocol & Study Review

• 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.

Clinical Data & Risk Management

• 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.

Cross-Functional Collaboration

• 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.

Ideal Candidate Profile

The ideal candidate would be a Senior/Principal Clinical Scientist, Clinical Development Director, Medical Director, Neurology Clinical Operations Lead, or Neurology SME with a combination of:

• Neurology and CIDP/GBS or related disease experience.
• Phase III or pivotal clinical trial experience.
• Protocol, endpoint, and clinical data review experience.
• Clinical operations and risk management expertise.

Priority should be given to candidates with direct CIDP experience and a strong background in pivotal or registrational neurology studies.

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