Medical Director – Nephrology, Internal Medicine

• Provide medical leadership to clinical 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 participant safety
• Identify medical issues early and proactively address customer concerns and corrections with the Global Medical Indication Lead
• Consult internal groups and support staff on procedural and budgetary items and protocol amendments
• Coordinate functions to close gaps and address issues timely and effectively
• Serve as chief liaison between the sponsor and PPD internal departments throughout all study phases
• Educate investigator sites through protocol-specific laboratory procedures presentations and demonstrations
• 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 questions from IRBs and Health Authorities
• 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 compliance with relevant SOPs and GCP
• Collaborate with cross-functional study team members to clarify medical risks, issues, and results

• Medical Doctor with a specialty in Nephrology or Internal Medicine
• Clinical experience treating nephrology patients in hospital practice
• Industry experience in clinical development
• Significant experience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine
• Fluent 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

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Equal employment opportunity and affirmative action environment
• Diverse, inclusive workplace where diverse experiences, backgrounds, and perspectives are valued