Medical Director – Pulmonology

• Provide medical leadership to study teams
• Create clinical trial protocols using the latest scientific information
• Contribute to site selection and review and approve study protocols and amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents
• Conduct real-time medical monitoring of clinical studies
• Ensure medical validity of primary endpoints and study subject safety
• Identify medical issues early and proactively address customer concerns and corrective actions
• Consult internal groups regarding procedural and budgetary items and protocol amendments
• Coordinate with functions to close gaps and address issues
• Serve as liaison between the sponsor and PPD 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
• Interact with investigators and answer IRB and Health Authority questions
• Prepare and present materials to study executives and independent safety committees when applicable
• Provide medical training to site staff and CRA training in new indications
• Ensure medical compliance by applying relevant SOPs and GCP
• Collaborate with cross-functional study team members on medical risks, issues, and results

• Medical Doctor with a specialty in Pulmonology
• Clinical experience treating pulmonology patients in hospital practice
• 1–2 years of industry experience in clinical development
• Significant experience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine
• Fluent spoken and written English
• Understanding and experience with NDA submission processes
• Understanding of regulatory guidelines for adverse event reporting
• Strong communication and presentation skills
• Strong teamwork skills

• Meaningful work making a positive impact on a global scale
• Resources to achieve individual career goals
• Work with life-changing therapies and clinical research services
• Equal employment opportunity and affirmative action
• Diverse experiences, backgrounds, and perspectives valued
• Standard Monday–Friday schedule