Medical Director

Job DetailExperience Level Executive DirectorDegree Type Bachelor of Science (BS)Employment Full TimeWorking Type HybridJob Reference 0000020065Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful safety strategies in a dynamic neuroscience portfolio. Collaborate with cross-functional teams in a hybrid work environment. Drive regulatory compliance and contribute to innovative drug safety solutions.Job DescriptionMedical Director OverviewThe 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 & DutiesLead 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 RequirementsMD 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.