Beschreibung

In this role, you will shape clinical development strategies by integrating insights and data, leading study designs, and collaborating with teams and CROs. Your work will involve analyzing data, preparing regulatory documents, and staying current with industry advancements.

Anforderungen

• •University degree in natural sciences or medicine
• •Minimum 3 years of experience in clinical development
• •PhD/Postdoctoral experience (≥5 years) in a relevant therapeutic area
• •Demonstrated experience in scientific writing and communication
• •Solid understanding of Good Clinical Practice (GCP) guidelines
• •Excellent communication and presentation skills in English
• •Proficient in Microsoft Office 365 and Adobe Acrobat

Aufgaben

• •Support translational strategy by integrating nonclinical, biomarker, and clinical insights
• •Contribute to the Target Product Profile (TPP) and Clinical Development Plan (CDP)
• •Lead or assist in designing clinical study protocols and final reports
• •Analyze clinical and translational data for target engagement and efficacy signals
• •Coordinate activities with internal teams and external CROs
• •Author and review clinical and regulatory documents, including ODD applications
• •Prepare and deliver scientific presentations for various audiences
• •Collaborate to assess in-licensing opportunities and new therapeutic targets
• •Stay updated on clinical pharmacology and regulatory science developments
• •Contribute to the creation and revision of Standard Operating Procedures (SOPs)

Tools & Technologien

Benefits