The responsibilities of this position include performing and overseeing quality assurance activities that support all QA aspects of the drug substance release process for clinical and future commercial batches.
The Director, Clinical operations is responsible for providing strategic vision and direction within the department of Clinical Operations. Ensures completeness and consistency of processes required for successful life cycle management for all phases of clinical trials across the therapeutic portfolio.
Participates actively in project teams. Works mostly independently but occasionally seeks the guidance of a more experienced programmer. Interact with external parties as a representative of Clinical Programming.
Collaborates cross-functionality with internal and external partners to determine clinical supply needs throughout the life of the study. Responsibilities include oversight of the forecasting, planning, labeling/packaging and distribution of clinical supplies and/or ancillary supplies for all clinical trials. This also includes site training, expiry date management, regulatory requests and overall supply management.
Collaborates with colleagues in clinical development and operations, research, bioPharma development and manufacturing, regulatory affairs, and product safety to participate in protocol development and the design of studies, statistical design, CRO selection and management, site monitoring, safety, clinical support of regulatory interaction, study reporting for new products that will ensure regulatory approval and commercial success.
Direct and oversee the design and implementation of early stage clinical projects as a member of our Product Development Team (PDT) and leader of the Product Steering Committee (PSC). Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan, are suitable to test the trial's hypothesis, and likely to meet the objectives of the trial while also ensuring study design elements that are ethical and consistent with standard of care and local practices