Senior Medical Director – Dermatology (EMEA)
Thermo Fisher Scientific · Portugal
وصف الوظيفة
About the role
The (Senior) Medical Director – Dermatology will provide medical leadership and expertise for dermatology clinical trials within Thermo Fisher Scientific’s PPD Pharmacovigilance department. The role involves shaping trial design, ensuring safety oversight, and acting as the primary medical liaison between sponsors, investigators, and internal teams across the EMEA region.
Key responsibilities
- Lead the development of clinical trial protocols, incorporating the latest scientific evidence.
- Participate in site selection, review and approval of study documents (CSRs, ICFs, CRFs, protocol amendments).
- Conduct real‑time medical monitoring of studies, ensuring validity of primary endpoints and subject safety.
- Serve as chief liaison between sponsor and all internal PPD departments throughout study phases.
- Educate investigators and site staff on protocol‑specific laboratory procedures and study requirements.
- Respond to queries from investigators, IRBs, and health authorities; prepare materials for safety committees.
- Ensure compliance with SOPs, GCP, and other regulatory standards.
Required profile
- Medical degree with extensive experience in clinical trial design and execution, preferably in dermatology.
- Proven track record in pharmacovigilance and safety evaluation.
- Strong understanding of GCP, SOPs, and regulatory requirements across the EMEA region.
- Excellent communication skills to interact with investigators, sponsors, and cross‑functional teams.
Required skills
- Good knowledge of Good Clinical Practice (GCP) and related SOPs.
- Experience with clinical trial documentation (protocols, CSRs, ICFs, CRFs).
- Medical monitoring and safety assessment expertise.
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Thermo Fisher Scientific
Portugal
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