Job Description

Responsibilities

• Design and provide oversight of clinical research programs for IVD products.
• Build and maintain strong relationships with key opinion leaders (KOLs) and integrate their feedback into study protocols and development strategy.
• Ensure clinical study design aligns with both scientific objectives and commercial goals.
• Lead planning and execution of clinical trials (Phases I–IV), ensuring adherence to GCP guidelines and all relevant regulatory requirements.
• Manage clinical budgets, project timelines, resources, and cross-functional coordination to ensure successful trial outcomes.
• Establish conditions for evaluating safety, efficacy, medical utility, and market potential of product candidates.
• Analyze and interpret clinical trial results in preparation for regulatory submissions (e.g., FDA, CE-IVDR).
• Serve as the clinical safety expert for one or more clinical development programs.

Qualifications

• Bachelor’s degree in a scientific, medical, or technical discipline.
• Minimum 7 years of experience in clinical research, clinical affairs, or related field within a regulated industry.
• Direct experience in the in vitro diagnostics (IVD) industry.
• Demonstrated ability to manage clinical trials from design through regulatory submission.
• Strong working knowledge of GCP, FDA, and international clinical trial standards.

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