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.