Important pharmaceutical company is looking for a Senior Clinical Program Director who will be accountable for the overall delivery of the clinical program to time, cost, and quality and is the leader of the Clinical Program Team.
Typical AccountabilitiesAccountable for leading the translation of science into crisp and robust clinical development plans, including operational design options for assigned program.Accountable for leadership of the Clinical Program Team (CPT) and its oversight of clinical program strategy activities within each assigned program.Accountable for providing strategic and operational input on clinical content to cross-functional program development plans.Accountable for cross-functional leadership roles as delegated from the eGPT, e.g., leadership of cross-functional product development team activities pertaining to clinical content.Accountable for ensuring the development of the clinical program strategy, including pediatric and rare disease strategy, and China/Japan plans within the CPT.Accountable for ensuring the implementation of innovative approaches to delivery with Development Operations, e.g., new delivery platforms and technology to ensure patient engagement, recruitment, and retention.Accountable for team leadership to provide clear direction and aligned goals to the CPT members and maintain a high performing clinical program team.Accountable for efficient and effective program management of all clinical development deliverables, including project strategy, design, and delivery of CPT driven program/studies to time, on budget and within quality.Drive CPT to contribute appropriate content to support high quality governance interactions.Provide and ensure expert clinical input into various clinical documents including, but not limited to, Target Product Profile (TPP), Clinical Development Plan (CDP), Study Synopsis, IB, briefing documents, governance interaction material (e.g., CDID, PH2ID, PH3ID).Provide input to Health Authority interactions (e.g., pre-IND meetings).Accountable to ensure timely selection of an appropriate delivery model including selection of external providers for program/study specific tasks.Acts as the operational interface with externally managed/outsourced partners (e.g., CRO/ARO) and collaboration/alliance partners for program planning and delivery.Accountable for development and management of contingency risk plans within each assigned clinical program to ensure operational delivery to quality, budget, and timelines.Ensure trial handover to assigned Global Study Lead (GSL) and study team.Post-study handover, carry out overall/strategic oversight to ensure that the study progresses according to E/SPC approved scope, cost, and timelines.Ensure consistent quality practices in alignment with highest ethical standards, GCP, ICH Guidelines, compliance with internal SOPs, local regulations and laws.Contribute to scientific interpretation of clinical data for discussion at governance meetings and external meetings.Coordinate and ensure KEE interactions and clinical advisory boards are accomplished to support clinical strategy and the development of the CDP.Coordinate the clinical component of governance review (ESB, DRC, ESPC/LSPC) preparation.Accountable for accurate budget forecasting, maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned program.Contribute to driving best practices and support process-related improvements and workstreams.Be early adopters for new ways of working and act as ambassadors for change.Mentor and support people development within Early clinical development and DevOps Study management.Ensure alignment of the clinical strategy, transfer of program knowledge and champion programs that are between early and late stage organizations.EssentialsBachelor of Science/Arts degree in related discipline, preferably in medical or biological science.
Advanced degree is preferred.Extensive global drug development experience demonstrated in a variety of related roles.Leadership skills.El anuncio original lo puedes encontrar en Kit Empleo: https://www.kitempleo.es/empleo/129964276/senior-clinical-program-director-eg700-barcelona/?utm_source=html
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