Associate Medical Director/Medical Director, Clinical Development(Neuroscience/Psychiatry)

Role Summary

Associate Medical Director/Medical Director, Clinical Development (Neuroscience/Psychiatry) – oversee direction, planning, execution and interpretation of clinical trials within a clinical development program, contributing to cross-functional teams to generate and interpret high-quality clinical data supporting product strategy.

Responsibilities

• With appropriate supervision, design and implement study protocols for a clinical development program and oversee education of investigators and study staff.
• Oversee clinical studies, monitor study integrity, review and interpret data on safety and efficacy, and manage enrollment timelines and key deliverables in collaboration with Clinical Operations; assess and report serious adverse events per policy and regulations.
• Contribute to the design, analysis, interpretation, and reporting of scientific content for protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions, and other documents.
• May serve on a Clinical Strategy Team as the clinical representative for assigned protocols; contribute to development of a rigorous Clinical Development Plan with matrix team members.
• Engage in opinion leader interactions related to the disease areas; partner with Medical Affairs, Commercial and other functions as required.
• Stay updated on professional information and technology to augment therapeutic area expertise.
• Understand regulatory requirements for clinical studies and global drug development; contribute to regulatory responses as needed.
• Ensure adherence to Good Clinical Practices, pharmacovigilance standards, SOPs and quality standards in research.

Qualifications

• Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent with relevant specialty; residency strongly preferred; subspecialty fellowship desirable.
• Ability to run a clinical research study with appropriate supervision.
• Ability to collaborate in a cross-functional setting.
• Clinical trial experience in pharmaceutical industry, academia, or equivalent preferred.
• Knowledge of clinical trial methodology, regulatory and compliance requirements; experience in protocol design desirable.
• Ability to interact externally and internally to support global scientific and business strategy.
• Excellent oral and written English communication skills.

Skills

• Cross-functional collaboration
• Clinical trial design and oversight
• Data interpretation and scientific reporting
• Regulatory and compliance awareness
• Stakeholder engagement and communication

Education

• Medical degree (M.D. or D.O.); residency completed; subspecialty fellowship desirable.