Senior Clinical Program Director
hace 3 semanas
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 Accountabilities
Accountable 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 and 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, and 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 to deliver excellence in clinical program management to maximize team performance and drive delivery
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, the following: Target Product Profile (TPP), Clinical Development Plan (CDP), Study Synopsis, IB, briefing documents, governance interaction material (e.g., CDID, PH2ID, PH3ID) etc., to ensure seamless delivery of programs through effective collaboration. 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, including management of program level issue escalation and resolution.
Accountable for initial feasibility assessment and early country and site engagement to assist with formulating budget forecast and trial 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 and to ensure a rapid response to emerging data (i.e., adapt the study/program as required based on emerging data).
Ensure consistent quality practices in alignment with highest ethical standards, GCP, ICH Guidelines, compliance with internal SOPs, local regulations and laws, etc.
Contribute to scientific interpretation of clinical data for discussion at governance meetings and external meetings, e.g., ad boards, conferences, etc.
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
Coordinate (if applicable through a MW) IB/clinical IMPD development. Provide input to DSUR.
Accountable for accurate budget forecasting, and maintenance, and monitoring to baseline, clinical program resourcing, scenario planning, plus overall timelines for trials within assigned program, including setup and maintenance within Company systems, e.g., PLANIT.
Contribute to driving best practices and support process-related improvements and workstreams, including alignment with digital health, clinical innovation, and ensuring timely compliance with Company governance controls
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
**Essentials**:
Bachelor 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
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