Executive Medical Director, Neurology, Clinical Development (Remote)

Contact: Alexandra Spink -
No 3rd party candidates

We are looking for an accomplished Executive Medical Director, Neurology Clinical Development to lead the strategy, execution, and oversight of global clinical development programs across neurology indications. This highly visible leadership role will drive clinical programs from early development through registration, provide medical leadership across cross-functional teams, and help shape the future of our neurology gene therapy portfolio.

As the medical lead for assigned programs, you will provide expert oversight of medical monitoring, clinical strategy, data interpretation, regulatory interactions, and scientific communications. Working collaboratively across Research, Clinical Operations, Regulatory Affairs, Biostatistics, Pharmacovigilance, Commercial, and other key stakeholders, you will play a critical role in advancing innovative therapies for patients with neurologic diseases.

Key Responsibilities

• Lead the strategy, design, and execution of global clinical development programs across Phases I–III.
• Serve as the therapeutic area lead for the Neurology Gene Therapy Clinical Development team, partnering with Clinical Operations, Toxicology, Regulatory Affairs, Commercial, Pharmacovigilance, Clinical Quality, and Biostatistics.
• Provide medical oversight for clinical trials, ensuring patient safety, protocol compliance, data integrity, and study quality.
• Lead clinical operational strategy, including site selection, enrollment, feasibility, and issue resolution.
• Collaborate with Clinical Operations on medical monitoring, safety review, coding, and data cleaning.
• Interpret clinical trial data and ensure the scientific integrity of study reports and communications.
• Author or oversee clinical sections of regulatory submissions, including INDs, NDAs, BLAs, and briefing books.
• Represent the company during regulatory agency interactions and Advisory Committee meetings.
• Develop safety management documents, DMC charters, investigator communications, and other study-related materials.
• Build relationships with CROs, investigators, key opinion leaders, consultants, and investigational sites.
• Analyze and present clinical data through publications, presentations, scientific meetings, and advisory boards.
• Maintain expertise in neurology and gene therapy through scientific literature and medical conferences.
• Manage clinical development budgets, timelines, risks, and program progress.
• Support business development, product evaluations, due diligence, and portfolio strategy.
• Provide medical expertise to internal and external stakeholders across research, development, commercial, regulatory, manufacturing, and patient-focused functions.
• Coach, mentor, and develop direct reports while fostering a collaborative, high-performing team.

Qualifications

• MD (or foreign equivalent) with clinical training and experience in Neurology required.
• PhD in a related scientific discipline preferred.
• 10+ years of global clinical development experience in the pharmaceutical or biotechnology industry across Phases I–III.
• 5+ years of leadership experience managing clinical development teams.
• Pediatric neurology experience preferred.
• Gene therapy experience preferred.
• Strong expertise in medical monitoring, clinical trial design, regulatory strategy, and clinical data interpretation.
• Thorough knowledge of ICH-GCP guidelines, FDA regulations, and global clinical development requirements.
• Excellent leadership, communication, and cross-functional collaboration skills.
• Ability to travel domestically and internationally up to 20%.