Senior Medical Director Clinical Development

Overview

• Lead clinical development initiatives for neurology and neuropsychiatric therapies, contributing to early and late-stage programs.
• Collaborate across departments and levels to drive impactful research and development efforts in neuroscience.
• Engage with global regulatory authorities, scientific organizations, and key thought leaders to advance therapeutic priorities.
• Contribute to strategic discussions on clinical development plans and asset prioritization.
• Provide medical oversight and monitoring for Phase 2 and Phase 3 clinical trials.
• Develop and maintain collaborative relationships with investigators and thought leaders globally.
• Critically review and contribute to regulatory submissions, including INDs and NDAs.
• Participate in business development due diligence activities as needed.

Key Responsibilities & Duties

• Design and execute protocols for early and late-stage clinical research trials in neurologic disorders.
• Serve as Global Clinical Lead for multiple programs, overseeing clinical subteams and operational aspects.
• Contribute to authorship of clinical study reports, regulatory documents, and external publications.
• Ensure compliance with clinical development SOPs and industry standards.
• Coordinate operational aspects of projects to meet time, cost, and quality goals.
• Represent the organization to clinical sites, opinion leaders, and patient advocacy groups.
• Plan and oversee clinical advisory boards, investigator meetings, and major medical conferences.
• Provide medical oversight for trial data and collaborate with CRO medical monitoring teams.

Job Requirements

• Doctor of Medicine (MD) with specialization in Psychiatry or Neurology.
• Board Certification in Neurology or Psychiatry preferred.
• Minimum two years of pharmaceutical industry experience; three years preferred.
• Proven expertise in drug development across early and late-stage clinical programs.
• Experience interacting with global regulatory agencies and successful NDA/BLA submissions.
• Outstanding written and verbal communication skills for senior management and external audiences.
• Ability to navigate complexity in a matrixed work environment and foster teamwork.
• Self-motivated with excellent task prioritization and deadline management skills.