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We are looking for a Clinical Develpment Director to a Swedish pharmaceutical company.
The Clinical Development Director will
o be responsible for efficient and effective clinical project management of all clinical development deliverables; scope, quality, budget, time, resource, and risk, including, but not limited to clinical components of regulatory and related submissions, clinical contributions to inspection readiness, governance interactions.
o together with the CMO have oversight of clinical development activities within the programs and for ensuring provision of clinical expertise/input into the program to ensure the delivery of the clinical program according to quality, cost and timelines in compliance with company governance and external regulations
o lead the implementation of new strategies in the clinical development of the product project management.
o lead the negotiation of contracts with external partners and vendors
o acts together with the CMO as the operational interface with externally managed/outsourced e.g. CRO partners for program planning and execution of outsourced studies.
o will facilitate strategic and project related external activities such as; KOL interactions, Scientific Advisory Boards etc
The Clinical Development Director partners with the CMO and VP for Strategy and Development to develop the overall project strategy, ensuring linkage between that strategy and clinical operational delivery.
o acts together with the VP Product Strategy & Development to enable the project team to deliver towards the objectives and provides the information to allow for decision making.
o will manage for efficient cross-functional project deliverables, including but not limited to:
o maintains accurate and transparent cross functional project plans
o drives the delivery of the cross-functional plan through pro-actively monitoring of key parameters
o leads sub-team activities for cross-functional deliverables
o ensures effective documentation of project team meetings, key decisions, and action items
o drives delivery of project risk management plans/ mitigation activities
o leads the championing of new strategies for product project management
The Clinical Development Director reports to the Chief Medical Officer.
If interest, please contact Jan Friberg, jfr@bondi.se mobile 0705871228.