Clinical Scientist - Manager​/Senior Manager; m​/f​/d

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.
• Take a lead role in writing protocol amendments, informed consents, and other protocol-related documents for the operational execution of clinical studies.
• 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.
• Actively identify areas of emerging risk for the execution of clinical studies and proposing solutions to minimize and mitigate risk. 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.
• Participate in investigator meetings, investigator engagement, including assisting in the preparation of Advisory Board meetings.
• 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.
• Participate in the training of site and company staff on the study protocol, ensure the clinical staff have the necessary guidance

• BS or BSN is minimally required. An advanced degree in a scientific discipline (i.e. MS, Pharm
  
  D, 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.
• Requires capabilities to work on additional studies moving into operation in later years. 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…