Medical Director - Nephrology/Internal Medicine, EMEA (Client Dedicated)

About the role

PPD, part of Thermo Fisher Scientific, is hiring a Medical Director for a client-dedicated position covering nephrology and internal medicine in the EMEA region. The role provides medical support and medical advice for clinical trials and safety evaluation within the client's environment, with a standard Monday-to-Friday office schedule.

Key responsibilities

• Lead the study teams medically, including creating clinical trial protocols and contributing to site selection
• Review and approve study protocols, amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs) and other clinical documents
• Monitor studies in real time for medical validity of endpoints and subject safety, and proactively correct issues with the Global Medical Indication Lead
• Act as chief liaison between the sponsor and PPD internal departments across all study phases
• Educate investigator sites with protocol-specific lab procedures and train CRAs on new indications
• Answer questions from IRBs and health authorities and prepare material for the study executive and independent safety committee
• Ensure study compliance with relevant SOPs and GCP, and collaborate closely with the cross-functional study team

Required profile

• Medical doctor with a specialty in Nephrology or Internal Medicine, with clinical experience running nephrology patients in hospital practice
• Experience in clinical development
• Significant experience in the pharmaceutical industry, clinical trials and pharmaceutical medicine
• Fluent spoken and written English

Required skills

• Understanding of the NDA submission process
• Understanding of regulatory guidelines for adverse event reporting
• Strong communication and presentation skills