As a Clinical Scientist (m/f/d) and member of our Clinical Development team, you will support the planning and execution of full life-cycle development of our antibody-drug conjugates (ADCs) global clinical trials. You will support the review, analysis, and interpretation of clinical trial data, contribute to the development of critical clinical trial documents, and take an active role in risk monitoring and mitigation. You will be part of a highly collaborative and cross-functional team involved with site evaluation, study start-up, study execution and management, and study close-out of our trials.
This position will report to the VP, Clinical and Translational Development and will be based in Munich or remotely in Germany.
Support the Medical Director in the oversight of clinical studies including review and interpretation of clinical trial data and timely execution of deliverables in collaboration with relevant internal and external partners.
Participate in the start-up of global clinical studies, working with Clinical Operations to ensure on schedule site activation and subject enrollment, monitoring, compliance with safety practices, policies, procedures as well as the day-to-day management of a clinical trial Implement clinical study parameters, deliverables, policy compliance and resource needs.
These may include meeting timelines in site activation, enrollment, identifying shortcomings or delays in data entry at clinical sites, and ensuring the timely execution of responses to regulatory interactions.
Play a key role in the review of study data to ensure timely and high-quality data entry, including review of case report forms, assists in coding, analysis, and proper and complete documentation of clinical data.
Support the Medical Director in managing sites to ensure study treatment discontinuation or other safety decisions are made per protocol and align with stakeholders within the study team.
Support the Medical Director to coordinate relevant and timely data analyses and presentations in collaboration with safety, data management, Data Monitoring Committee, Biostatistics, Pharmacometrics and Biomarker teams to meet timelines for safety monitoring committee meetings, regulatory documents and to internal reviews to make timely program decisions regarding study objectives.
MS, PharmD, PhD, MD) is preferred.
A minimum of 3 years of clinical development research in oncology, or related clinical research experience within the industry (pharmaceutical, biotech, CRO) is required.
Strong knowledge in clinical development in Oncology development is required.
Significant experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring.
Significant experience with data integrity, exploration, analysis and presentation.
High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to early disease clinical research and the highest personal and ethical standards.
Must be equally comfortable among the team to which he/she is assigned and in the global environment in which the Company operates.
This will involve close interaction and working closely with the discovery, biomarkers, clinical pharmacology, pharmacometrics, regulatory, biostatistics, clinical operations and Clinical Development.
Hold a strong understanding how these various functions work, the Clinical Scientist should be capable of implementing translational medicine approaches for clinical development.
We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.
Global mindset : Work in an international, diverse team.
Innovation every day : Push boundaries with cutting-edge science.