Senior Medical Director – Dermatology/Allergology/Immunology

• Provide medical leadership to study teams for Dermatology clinical trials and safety evaluation within the PPD Pharmacovigilance department
• Create clinical trial protocols using the latest scientific information
• Contribute to site selection and review and approve study protocols, amendments, CSRs, ICFs, CRFs, protocol deviation decisions, and other clinical documents
• Conduct real-time medical monitoring of clinical studies and ensure endpoint validity and subject safety
• Identify medical issues early and address customer concerns in consultation with the Global Medical Indication Lead
• Consult internal groups on procedural and budgetary items and protocol amendments
• Coordinate internal departments and liaise between the sponsor and PPD departments throughout study phases
• Educate investigator sites through protocol-specific lab procedure presentations and demonstrations
• Manage day-to-day clinical trial activities, resolve issues, and answer queries
• Act as the 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 when applicable
• Provide medical training to site staff and CRA training in new indications
• Ensure compliance with medical aspects of studies by applying relevant SOPs and GCP
• Collaborate with cross-functional study teams to communicate medical risks, issues, and results

• Medical Doctor with a specialty in Dermatology, Allergology, Immunology, or Rheumatology
• 2+ years of experience within the pharmaceutical industry, clinical trials, and pharmaceutical medicine
• Previous experience in a hospital setting
• Fluency in spoken and written English
• Understanding and experience with the NDA submission process
• Understanding of regulatory guidelines for adverse event reporting
• Strong communication and presentation skills
• Strong teamwork skills
• Understanding and application of relevant SOPs and GCP

• Global company resources to support individual career goals
• Meaningful work contributing to healthier, cleaner and safer outcomes
• Diverse and inclusive workplace valuing varied experiences, backgrounds and perspectives
• EEO/Affirmative Action protections
• Opportunity to work with clinical research, digital and decentralized clinical trial services