Senior Medical Director – Rheumatology, EMEA

• Provide medical leadership to clinical study teams
• Create clinical trial protocols using current scientific information
• Contribute to site selection and review or approve study protocols and amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents
• Perform 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 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 the sponsor and PPD internal departments throughout study phases
• Educate investigator sites on protocol-specific laboratory procedures
• Manage day-to-day clinical trial activities and resolve issues or 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
• Provide medical training to site staff and CRA training for new indications
• Ensure compliance with medical aspects of studies, SOPs, and GCP
• Collaborate with cross-functional study teams to communicate medical risks, issues, and results

• Medical Doctor, with a specialty in Rheumatology
• Clinical experience treating patients in hospital
• 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
• Strong teamwork skills
• Ability to understand and apply relevant SOPs and GCP

• Global career development resources
• Work with a global team of 100,000+ colleagues
• EEO/Affirmative Action workplace
• Meaningful work supporting life-changing therapies and improved health outcomes