Medical Director – Psychiatry

• Provide medical leadership to study teams, including creating clinical trial protocols and implementing the latest scientific information
• Contribute to site selection
• Review and approve study protocols, amendments, Clinical Study Reports, Informed Consent Forms, Case Report Forms, protocol deviation decisions and other clinical documents
• Perform real-time medical monitoring of clinical studies, ensuring endpoint validity and subject safety
• Identify medical issues early and address customer concerns with the Global Medical Indication Lead
• Consult internal groups and support staff regarding procedural and budgetary items and protocol amendments
• Acquire cross-functional dedication to close gaps and address issues timely and effectively
• Serve as chief liaison between the sponsor and PPD internal departments throughout study phases
• Educate investigator sites through protocol-specific lab procedures presentations and demonstrations
• Control, handle and follow day-to-day clinical trial activities to resolve issues and answer queries
• Act as medical point of contact for internal and external stakeholders
• Interact with investigators and answer IRB and Health Authority questions
• Prepare and present material to study executives and independent safety committees when applicable
• Provide medical training to site staff and CRA training in new indications
• Ensure study compliance with relevant SOPs and GCP
• Collaborate with cross-functional study team members to clarify medical risks, issues and results

• Medical Doctor
• Board-certified in Psychiatry
• Shown clinical experience running Psychiatry patients in hospital practice
• Industry experience in clinical development required
• Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine
• Fluent in spoken and written English
• Shown understanding and experience with NDA submission process
• Shown understanding of regulatory guidelines for adverse event reporting
• Strong communication & presentation skills
• Strong teammate

• Resources needed to achieve individual career goals
• Diverse experiences, backgrounds and perspectives are valued
• Equal employment opportunity and affirmative action employer