London, United Kingdom | full time | Job ID: 11593

Your Contribution

• Contribute to designing clinical trials to evaluate the safety and efficacy of investigational drugs. This includes developing the study protocol, identifying patient populations, selecting study endpoints, and determining the appropriate study design.
• Responsible for clinical development oversight of clinical trials to ensure that they are conducted in accordance with the protocol, regulatory requirements, and ethical standards. This includes monitoring study progress, reviewing study data, and ensuring that adverse events are reported and managed appropriately.
• Contribute to and/or lead the creation of study-level documents, including protocol development, preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. Contribute to the review and writing of clinical trial documents for CTR activities, and publications (if applicable).
• Under guidance of Clinical Development Lead, address regulatory/health authority queries and ensure compliance with guidelines.
• Contribute to the development of the Clinical Development Plan, Integrated Evidence Plan and the clinical component of the TPP.
• Collaborate with cross-functional teams, including, but not limited to, clinical operations, biostatistics, regulatory affairs, and medical affairs, to ensure the successful execution of clinical development programs.
• Develop protocol and clinically relevant training materials, share best practices and provide training to the broader clinical trial teams, investigator sites, CRO partners, etc.
• Collaborate with medical safety and pharmacovigilance on safety evaluations and signal detection.
• Contribute to aggregate reports, patient narrative reviews, attendance of pharmacovigilance monitoring meetings.
• Support regulatory activities, like preparation of meetings with regulatory agencies.
• Support preparation and (if applicable) participate in study level meetings, for example Investigator Meetings, Data Monitoring meetings, and others.
• Supports and guides the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). This could also include support for Case Report Form (CRF) development, and implementation of data capture tools.
• Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle.
• Work to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Provide insights and facilitate data review process improvements, for example by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement.
• Work effectively in a matrixed team within the clinical science organization. For Director level this includes providing guidance and mentorship to junior team members.