Senior Medical Director Clinical Development

Senior Medical Director Clinical Development Overview

• The Senior Medical Director Clinical Development will oversee clinical trials for neuropsychiatric therapies, ensuring protocol design and execution excellence.
• Collaborate cross-functionally with regulatory, research, and commercial teams to align therapeutic priorities and strategies.
• Engage with global regulatory authorities and key thought leaders to advance clinical development initiatives.
• Contribute to strategic discussions regarding clinical development plans and indication prioritization.
• Participate in operational oversight to ensure clinical trial goals are met efficiently and effectively.
• Provide medical review and monitoring for Phase 2 and Phase 3 clinical trials in collaboration with CROs.
• Represent the organization at clinical advisory boards, investigator meetings, and major medical conferences.
• Mentor junior clinical research colleagues and contribute to professional development within the team.

Senior Medical Director Clinical Development Key Responsibilities & Duties

• Design and execute clinical trial protocols for neuropsychiatric disorders, ensuring compliance with industry standards.
• Serve as Global Clinical Lead for programs, leading clinical subteams and contributing to strategic planning.
• Author clinical study reports, regulatory documents, and publications to support trial outcomes and approvals.
• Coordinate operational aspects of projects to meet performance expectations in time, cost, and quality.
• Develop collaborative relationships with investigators and thought leaders globally to enhance clinical research.
• Oversee medical monitoring and review clinical trial data to ensure accuracy and integrity.
• Contribute to regulatory interactions, including INDs and NDAs, ensuring successful submissions and approvals.
• Attend and present at major medical conferences, representing the organization to external audiences.

Senior Medical Director Clinical Development Job Requirements

• Doctor of Medicine (MD) with extensive drug development experience in psychiatry.
• 5-7 years of pharmaceutical industry experience, including early and late-stage clinical programs.
• Proven success in NDA or BLA submissions and approvals with global regulatory agencies.
• Outstanding written and verbal communication skills for interaction with senior management and external audiences.
• Ability to manage complexity and ambiguity in a matrixed work environment.
• Strong leadership and collaborative interpersonal skills for effective team management.
• Experience in mentoring clinical research colleagues and fostering professional growth.
• Willingness to travel domestically and internationally approximately 25% of the time.