• Serve as subject matter expert for internal project teams, providing guidance from clinical perspective.
• Create written material for clinical sections of key regulatory submissions; interface with regulatory authorities in each country to provide support for regulatory submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.
• Contribute to the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly.
• Actively contribute to the formulation of clinical trial protocols with sufficient feasibility and high probability of success based on expertise in the disease area.
• Provide input from the clinical perspective to the formulation of Target Product Profiles.
• Analyze safety and efficacy findings from clinical studies; participate in inter-disciplinary team meetings, as required
• Support required safety evaluations for clinical studies, e.g. SAE assessment, as needed.
• Perform close oversight of work performed by external medical monitors involved in group’s clinical studies
• Maintain knowledge of scientific developments in field and activities of competitors.
• Create and maintain good relationships with KOLs and clinical investigators; identify physicians with potential to serve as strong investigators for clinical studies.
• Attend relevant scientific meetings to strengthen competency in field and to gain awareness of research activities underway.
• Lead and author the publications and meeting presentations of clinical trials and review articles in cooperation with Medical Writing.
• Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics)
• Perform other duties, as required.