Senior Clinical Program Director, Early Clinical
hace 5 meses
The Senior Clinical Program Director (Senior CPD) is accountable for the overall delivery of the clinical program to time, cost and quality and is the leader of the Clinical Program Team (CPT). The Senior CPD will be required to work closely with the core CPT members to ensure that the clinical strategy and deliverables for the clinical program are delivered to the Early Global Product Team (eGPT). The role provides strategic oversight and feasibility input into the design of the clinical program and plays a key role in the work required to determine possible program design options. The Senior CPD focus is across the program level, collaborating with the Development Operations (Dev Ops) organization, Clinical Project Team (CPT) members, eGPT colleagues and all other functions that are key to the development of a compound.
The Senior CPD is expected to be a highly experienced drug developer and have organisational understanding and influence. The Senior CPD will drive and guide the CPT and each of its functions and enhance team work, productivity and depth of quality. The Senior CPD is responsible for driving the clinical strategy, implementation and forward planning. The Senior CPD, as the CPT Leader, will guide the eGPT in aspects related to the clinical development plan and influence from pre-Clinical to Commercial with other core CPT members. The role will establish and monitor best practices and be responsible for quality goal setting for the CPT deliverables.
**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 paediatric 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 initial and program-level AZ 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 accomplishe
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