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• Execute and manage Phase 1-3 clinical trials for biologic drug candidates. • Collaborate with cross-functional teams to ensure protocol adherence and trial progress. • Develop clinical documents like protocols and study reports. • Lead the preparation of regulatory submission components and clinical study reports.
• PhD or Master's degree with relevant experience in clinical trials. • Hands-on experience with Phase 1-3 trials and medical writing preferred. • In-depth knowledge of GCP and regulatory requirements. • Excellent written and verbal communication skills. • Ability to work independently in a fast-paced environment. • Experience with regulatory submissions is a plus. • Strong organizational skills and professionalism, especially under pressure. • Open to innovative methods and strategies.
• COVID-19 vaccination required for all employees, except where legally exempt. • Equal employment opportunity commitment regardless of personal attributes.
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💰 $35.2M Venture Round on 2021-03
⏰ Full Time
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