Medical Director – Nephrology/Internal Medicine
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Job Description
Medical Director providing nephrology and internal medicine leadership for clinical trials at Thermo Fisher Scientific. Monitoring safety, regulatory compliance and study execution across EMEA.
Responsibilities:
- Provide medical support and medical advice for clinical trials and safety evaluation within the client environment
- 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, 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 subject safety
- Identify medical issues early and address customer concerns and corrective actions with the Global Medical Indication Lead
- Consult internal groups on procedural and budgetary items and protocol amendments
- Coordinate internal functions to close gaps and address issues
- Liaise between the sponsor and PPD internal departments throughout study phases
- Educate investigator sites through protocol-specific lab procedures presentations and demonstrations
- Manage day-to-day clinical trial activities, resolve issues and answer queries
- Serve 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
- Deliver medical training to site staff and CRA training in new indications
- Ensure medical compliance with relevant SOPs and GCP
- Collaborate with cross-functional study teams on medical risks, issues and results
Requirements:
- Medical Doctor, with a specialty in Nephrology or Internal Medicine
- Shown clinical experience running nephrology patients in hospital practice
- Industry experience in clinical development required
- Significant experience within pharmaceutical industry, clinical trials and pharmaceutical medicine
- Fluent in spoken and written English
- Shown understanding and experience with NDA submission process
- Shown understanding of regulatory guidelines for adverse event reporting
- Strong communication & presentation skills
- Strong teammate
- Understanding and application of relevant SOPs and GCP
Benefits:
- Resources needed to achieve individual career goals
- Diverse experiences, backgrounds and perspectives are valued
- EEO/Affirmative Action protections
- Standard Monday–Friday work schedule
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