1 maand geleden
* Creation and development of a network of methodological Experts and KOLs Globally
* Cross functional management of project teams in matrix organisation, (clinical project managers, data managers, bio-statisticians
* Identification of TPP, design of Clinical Development Plan
* Defines the objectives, strategy, milestones and resources required for clinical development, at least up to registration in line with the TPP and Target Product claims.
* Serve as permanent member of the Project Core Team, representing Global Clinical Development.
* Day to day management and support of Global Development Team Members
* Leads/chairs the Medical Sub Team (MST).
* Provides guidance to Clinical Study Teams to ensure alignment of clinical trials planning and conduct with the overall development strategy.
* Defines protocol outlines.
* Ensure s/he is knowledgeable about both clinical safety and efficacy aspects of the product under development and seek internal or external advice as appropriate.
* Review and approves (when applicable ) key clinical trial documents (e.g. protocol, SAP, CSR).
* Responsible for clinical content for key internal or external project related documents (eg.IND, IB, briefing package for regulatory authorities, ISE, ISS, publication).
* Identifies and manages the Clinical risks and opportunities.
* Participate in the selection of CROs for clinical studies.
* Delivery and maintenance of the Clinical Development Plan that contains the strategic and scientific elements of clinical development to deliver a product with an optimal value that can be registered and commercialised
* Delivery of all aspects of the Clinical Development Plan including all clinical trials on time and on budget and according to the principles of Good Clinical Practice and applicable regulations
* Presenting the compound, protocols and results at expert meetings, advisory boards, congresses, or to regulatory authorities
* Primary publications of studies in alignment with the publication strategy and in alignment with regulatory requirements
* MD degree required. Advanced knowledge and training in Nephrology required,
* Clinical practice experience ≥ 3 years (including residency) preferred
* Experience in involvement in clinical research and drug development in an academy or industry environment
* Minimum 3 years' experience of global clinical development, especially in EU and USA, contributing to all aspects of designing and conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in biotech or pharmaceutical industry
* Experience in interactions with Health Authorities (e.g. FDA, EMEA, PMDA...)
* Early and late stage drug clinical development experience preferred
* Orphan Drug Designation experience is a plus
* Demonstrated ability to establish strong scientific partnership with key stakeholders and work in a matrixed multifunctional environment
* Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process.