Associate Medical Director – Rheumatology (EMEA)
Thermo Fisher Scientific
Job description
About the role
The Associate Medical Director will provide medical support and advice for clinical trials and safety evaluation within the PPD Pharmacovigilance department, contributing to the development of life‑changing therapies across the EMEA region.
Key responsibilities
- Lead study teams in creating and reviewing clinical trial protocols, amendments, and related documents (CSRs, ICFs, CRFs).
- Participate in site selection, protocol deviation decisions, and real‑time medical monitoring of trials.
- Ensure medical validity of primary endpoints and subject safety, identifying issues early.
- Serve as the primary liaison between sponsors and internal PPD departments throughout all study phases.
- Educate investigator sites through protocol‑specific presentations and training sessions.
- Act as the medical point of contact for investigators, IRBs, health authorities, and safety committees.
- Maintain compliance with SOPs, GCP, and regulatory requirements.
- Collaborate cross‑functionally to address procedural, budgetary, and operational challenges.
Required profile
- Medical degree with extensive experience in clinical trials, preferably in rheumatology.
- Strong background in pharmacovigilance and safety evaluation.
- Proven ability to lead multidisciplinary study teams and communicate with diverse stakeholders.
- In‑depth knowledge of SOPs, GCP, and regulatory guidelines.
Required skills
- Medical leadership in clinical research.
- Protocol development and review.
- Safety monitoring and pharmacovigilance.
- Regulatory interaction and compliance.
- Investigator training and stakeholder communication.
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Published 1 month ago
Expires 11 hours from now
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Thermo Fisher Scientific
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