Medical Director

Medical Director Overview

• The Medical Director will provide strategic safety oversight for investigational and marketed products within the Neuroscience portfolio.
• Collaborate with leadership to ensure effective communication and alignment on safety strategies and evolving issues.
• Lead critical projects with accountability, urgency, and a commitment to high-quality deliverables.
• Act as a safety expert in company-wide forums, providing advisement on clinical and post-marketing programs.
• Develop risk management strategies and oversee benefit-risk evaluations for assigned products.
• Ensure compliance with safety regulations and industry standards, contributing to regulatory documents and publications.
• Provide medical leadership in drug safety and benefit-risk management activities.
• Collaborate with cross-functional teams to enhance safety processes and strategies.
• Support business development activities with medical and safety expertise.

Medical Director Key Responsibilities & Duties

• Lead product safety surveillance and signaling activities, ensuring timely documentation and investigation.
• Provide strategic advisement on clinical development plans and protocol designs.
• Oversee the development of risk management plans and aggregate safety reports.
• Contribute to regulatory documents, including labeling, clinical overviews, and annual reports.
• Act as a resource for safety findings, regulations, and processes across teams and leadership.
• Lead benefit-risk assessments and communicate findings to the Safety Committee.
• Collaborate with teams on post-approval safety studies and epidemiology projects.
• Respond to product safety queries from regulatory authorities and ethics committees.
• Ensure compliance with US and EU safety regulations and standards.

Medical Director Job Requirements

• MD or MD/PhD with a minimum of 8 years in Drug Safety & Pharmacovigilance.
• Experience in patient care, clinical development, and clinical pharmacology preferred.
• Knowledge of neuroscience therapeutic space and safety regulations highly desirable.
• Strong strategic thinking, leadership, and collaboration skills in matrixed environments.
• Excellent communication and organizational skills with a sense of urgency and accountability.
• Proficiency in pre- and post-marketing US and EU safety regulations.
• Bachelor of Science degree required; advanced degrees preferred.
• Ability to lead and contribute effectively within cross-functional teams.
• Experience in risk management and benefit-risk evaluation strategies.