Clinical Research

• Lead the clinical development strategy and prepare Clinical Development Plans (CDP) for clinical programs and clinical trial protocols
• Responsible for assets from early phase through to registration and approval process
• Oversee and potentially supervise junior clinical team members; provide hands-on tactical work in project teams
• Collaborate with clinical/preclinical teams and cross-functional partners across Development Organization
• Work with Clinical Trial Investigators and Clinical Research Organizations on trial site selection, training and ongoing study conduct
• Ensure studies are performed with highest quality; perform data review and analysis and present clinical data
• Lead generation of clinical study reports and participate in preparation of regulatory documents (Investigator Brochures, CSRs, Briefing documents)
• Participate in face-to-face meetings with regulatory agencies and contribute to global regulatory submissions
• Maintain high level of medical science and clinical development expertise
• Collaborate on business development activities
• Perform responsibilities in compliance with company policies, SOPs and guidelines
• Represent Clinical Research function on program-aligned governance, operational committees and corporate projects as required
• Ability to travel, both domestic and international (25%)

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