Associate Medical Director – Neurology

• Provide medical leadership to study teams and contribute to clinical trial protocols, site selection, protocol and amendment review, CSRs, ICFs, CRFs, protocol deviation decisions and other clinical documents
• Perform real-time medical monitoring of clinical studies, ensuring endpoint validity, subject safety and early identification of medical issues
• Address customer concerns and correct issues in consultation with the Global Medical Indication Lead
• Consult internal groups on procedural and budgetary items and protocol amendments
• Coordinate internal functions to close gaps and resolve issues
• Serve as liaison between sponsors and internal departments throughout study phases
• Educate investigator sites on protocol-specific laboratory procedures
• Manage day-to-day clinical trial activities, resolve issues and answer queries
• Act as medical point of contact for internal and external stakeholders, investigators, IRBs and Health Authorities
• Prepare and present materials to study executives and independent safety committees
• Provide medical training to site staff and CRA training in new indications
• Ensure medical compliance with relevant SOPs and GCP
• Collaborate with cross-functional study teams to communicate medical risks, issues and results

• MD, MB/BS or equivalent degree
• Strong medical knowledge
• Clinical experience running Neurology patients in hospital practice
• Significant experience within the pharmaceutical industry, clinical trials and pharmaceutical medicine
• Fluency in spoken and written English
• Understanding and experience with NDA submission process
• Understanding of regulatory guidelines for adverse event reporting
• Strong communication and presentation skills
• Epileptology experience is advantageous

• EEO/Affirmative Action Employer
• Mission-driven work contributing to healthier, cleaner and safer outcomes
• Resources to achieve individual career goals
• Diverse and inclusive workplace where diverse experiences, backgrounds and perspectives are valued