Senior Clinical Scientist

We aim to reduce the suffering of people with life-changing therapies by harnessing the potential of the immune system to develop novel therapies against cancer and infectious diseases. While doing so, we are guided by our three company values: united, innovative, passionate. Get in touch with us if you are looking to be a part of creating hope for a healthy future in many people's lives.

Responsibilities

• Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations. Also contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead.
• Contribute to the creation of study-level documents, including 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).
• Support pharmacovigilance activities (e.g. contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings)
• Support regulatory activities, like preparation of meetings with regulatory agencies.
• Produce training materials, share best practices and provide training to the broader clinical trial teams.
• 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 to 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.
• For all these tasks, work in close collaboration and alignment with clinical development lead. Ensure all questions / issues requiring medical oversight are brought to the attention of the clinical development lead.

Qualifications

• Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required.
• Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
• 3+ years as a Clinical Trial Scientist or comparable role.
• 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 institution.
• Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Ideally first experiences in how to improve and accelerate processes, systems and tools and drive continuous improvement.
• Experience in RDC is an advantage.
• Experience to work 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); German a plus.