Director / Associate Director / Senior Manager, Clinical Science

Your Contribution

• Contribute to designing clinical trials to evaluate the safety and efficacy of investigational drugs, including 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 they are conducted in accordance with the protocol, regulatory requirements, and ethical standards, including monitoring study progress, reviewing study data, and ensuring adverse events are reported and managed appropriately.
• Contribute to and/or lead the creation of study-level documents, including protocol development and preparation of clinical sections of key regulatory documents such as Investigator's Brochures, briefing books, safety updates, and submission dossiers.
• 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 clinical operations, biostatistics, regulatory affairs, and medical affairs to ensure successful execution of clinical development programs.
• Develop protocol and clinically relevant training materials, share best practices, and provide training to clinical trial teams, investigator sites, and CRO partners.
• Collaborate with medical safety and pharmacovigilance on safety evaluations and signal detection.
• Contribute to aggregate reports, patient narrative reviews, and pharmacovigilance monitoring meetings.
• Support regulatory activities, including preparation of meetings with regulatory agencies.
• Support preparation and participate in study-level meetings such as Investigator Meetings and Data Monitoring meetings.
• Support and guide the development of data review strategy, ensuring protocol-level deviations, eligibility criteria, and study assessments are implemented consistently across countries and sites.
• Perform high quality clinical data review and identify clinical data insights through ongoing patient-level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities.
• Work to improve the quality of reviews and insights with emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation.
• Provide insights and facilitate data review process improvements, including identification of redundant reports and implementation of innovative data analysis processes and tools.
• Work effectively in a matrixed team within the clinical science organization; for Director level this includes providing guidance and mentorship to junior team members.

A Good Match

• College degree in life sciences/healthcare/nursing; advanced degree preferred.
• 8+ years of industry experience.
• Strong familiarization with Good Clinical Practice (GCP) and drug development processes, ideally Phase 1-3, ideally paired with experience in Oncology/Immuno-Oncology.
• Good knowledge of set-up, organization, and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO), or comparable experience within academic research institutions.
• Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel) for data collection, analysis, and reporting.
• Experience working in a matrix, ability to influence without authority.
• High flexibility and adaptive working style, ability to work on several tasks at the same time.
• Ability to work effectively under high time pressure while maintaining high quality standards.
• Ability to effectively prioritize tasks and implement accordingly.
• High proficiency in English (written and spoken).