Job Description
Key Responsibilities
Clinical Development & Trial Execution
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Lead and support Phase I–III clinical studies from study design through completion
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Provide scientific and operational oversight of clinical trials conducted with external research partners
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Contribute to protocol development, study strategy, and clinical development plans
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Ensure trials are conducted in accordance with ICH-GCP, regulatory requirements, and company SOPs
Clinical Writing (Hands-on)
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Author, review, and finalize key clinical documents, including:
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Clinical study protocols and amendments
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Clinical Study Reports (CSRs)
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Investigator’s Brochures (IBs)
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Informed Consent Forms (ICFs)
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Clinical sections of regulatory submissions and responses
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