Medical Director – Dermatology/Allergology/Immunology (EMEA)
Thermo Fisher Scientific
Descrição do cargo
About the role
The (Senior) Medical Director will provide medical leadership and expertise for dermatology, allergology and immunology clinical trials across the EMEA region, supporting safety evaluation within the PPD Pharmacovigilance department.
Key responsibilities
- Lead study teams in creating and reviewing clinical trial protocols, amendments, CSRs, ICFs, CRFs and other key documents.
- Conduct real‑time medical monitoring of studies to ensure validity of primary endpoints and early detection of safety issues.
- Serve as chief liaison between the sponsor and internal PPD departments throughout all study phases.
- Educate investigator sites through protocol‑specific presentations and hands‑on lab procedure demonstrations.
- Act as the primary medical point of contact for investigators, IRBs, health authorities and internal stakeholders, providing training and answering queries.
- Ensure study compliance with SOPs and GCP by applying relevant regulatory guidelines.
- Collaborate closely with cross‑functional teams to communicate medical risks, issues and results clearly.
Required profile
- Medical Doctor with a specialty in Dermatology, Allergology, Immunology or Rheumatology.
- Minimum 2 years of experience in the pharmaceutical industry, clinical trials and pharmaceutical medicine.
- Previous experience in a hospital setting.
- Fluent in spoken and written English.
- Understanding of NDA submission processes and regulatory guidelines for adverse event reporting.
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