Clinical Development Quality Lead
Key responsibilities: Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD
Clinical Development Quality Lead
Develop a “risk-based” compound-specific compliance program contributing to document / data accuracy, ultimately resulting in “dossier acceptability” by respective out-licensing partners (emphasis on eCTD Module 5)…
Work closely with the Global Program Head(s) and Global Project Leaders (GPLs) to support/contribute to the development of the program strategy and its integrated development plan.
Guide innovation, provide drug development expertise and strategic leadership to the programs and project teams, comprising all pre-clinical, clinical, technical, regulatory, operational and commercial disciplines
Senior Clinical Scientist, Clinical Development
Drive development of protocols/protocol amendments for clinical studies. Prepare and/or provide input to clinical study related and other regulatory documents (e.g. CSRs, IBs, PIS/ICFs, SAPs, Data Management Plans, Safety Management Plan, Medical Monitoring Plan, SRC Charter, IND, briefing books)
Associate Medical Director Oncology, Clinical Development
Be an integral member of the clinical development team and the clinical study team and drive execution of the clinical study in partnership with other functions
Translational Medicine G(c)LP Quality Lead
Contribute to Vendor selection and qualification process, assess Vendor’s procedures during selection process, guaranteeing compliance with regulatory requirements & verify G(c)LP certification, for TM vendors contributing to numerous PK & biomarkers assessments in DPI’s pre-clinical and clinical programs
Global Program Lead, Global Regulatory Affairs
Lead, develop and implement the global RA strategy for assigned project. Represent RA in Project Teams and in various other cross-functional teams, such as Clinical Study Teams. Present and defend regulatory plans to Debiopharm internal governance bodies.
Senior Global Clinical Trial Manager Phase 3
Develop clinical strategy for the therapeutic area in the assigned oncology program(s) (oncology – hematology) taking into account current medical practice and unmet needs; advances in both biological sciences and data sources; as well as competitive environment
Senior/Principal Biostatistician, Global Clinical Development
Provide expert statistical input to the design, analysis and interpretation of clinical studies, and development plans, primarily within Oncology
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