Development Scientific Director, Neurology (Early Development)

Role Summary

Development Scientific Director, Neurology (Early Development) role provides clinical scientific leadership for Alzheimer’s disease clinical trials within the Neurology Clinical Development department. The role involves protocol development, study feasibility and risk assessment, regulatory submissions, protocol training, scientific review of data, and cross-functional collaboration to ensure scientific integrity and operational excellence. Requires a scientifically and operationally focused, organized, and emotionally intelligent professional with strong analytical, communication, and leadership skills.

Responsibilities

• Provide scientific expertise for study protocols, data interpretation, and clinical study reports.
• Ensure scientific relevance and quality of clinical data throughout study execution.
• Support feasibility assessments, risk management, and validation of clinical data.
• Participate in internal governance and regulatory meetings.
• Serve as the scientific reference for study teams, investigators, and internal stakeholders.
• Collaborate with Global Project Heads, Clinical Research Director, Safety Officer and Pharmacovigilance, Translational Medicine, Regulatory Affairs, Biostatistics, Clinical Study Units, Medical Affairs, and CROs to optimize study design and execution.
• Author, review, and validate study-related documents including trial protocols, informed consent forms, case report forms, risk management plans, training materials, clinical study reports, and publications.
• Develop materials for and organize investigator meetings, steering committees, and independent data monitoring committees.
• Contribute to regulatory submissions and respond to health authority queries.
• Maintain deep knowledge of Alzheimer‚Äôs disease pathophysiology, biomarkers, disease staging, clinical management, and drug development.
• Contribute to biomarker strategy and mechanism-of-action understanding.
• Support clinical development plans and integrated development strategies.
• Provide scientific input for in-licensing evaluations and strategic initiatives as needed.
• Define study timelines, budgets, and risk mitigation plans in collaboration with clinical operations and project management.
• Ensure harmonization of study documents and alignment across projects.
• Escalate and resolve study-level issues, sharing lessons learned across teams.

Qualifications

• Advanced degree (PhD, PharmD, or equivalent in Life/Health Sciences); MPH or Master‚Äôs with extensive drug development experience may be considered.
• Minimum 5 years of clinical development experience in academic, biopharma, or CRO.
• Strong scientific and clinical development expertise, especially in neurology. Clinical research and drug development expertise in Alzheimer‚Äôs disease is highly desired.
• Excellent communication, teaching, and cross-functional collaboration skills.
• Fluent in English (spoken and written).
• Experience working in a matrixed environment with global teams.