Senior Global Clinical Operations Program Director
hace 2 semanas
Important pharmaceutical company is looking for a Senior Global Clinical Operations Program Director. The person will be responsible for:
**Main accountabilities**:
- Accountable for oversight of all clinical program activities, ensuring relevant issues are escalated to GPT (or equivalent team) and for ensuring provision of clinical operations expertise/input into the program (e.g. feasibility, country selection, operational input into design, risk and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
- Effectively partner with the Global Clinical Head (GCH) and the Biometrics Team Leader to provide leadership, clear direction and aligned goals to the CPT members/clinical delivery teams
- As a member of the CPT, responsible for efficient and effective program management of all GPT (or equivalent team) clinical development deliverables, including strategy, design and delivery of clinical program/studies to scope, quality, budget, time; managing resource and risk.
- Accountable for establishing team structure and ways of working to ensure CPT is a high performing team.
- Accountable for line management of Clinical operational leaders at the Global Study level (Global Study Associate Directors, GSAD or Global Study Directors, GSD) and program level (Global Program Director GPD) associated within the aligned GPT deliverables.
- Accountable for the clinical operations component deliverables of regulatory submissions, providing support for regulatory interactions and reports and clinical contributions to inspection readiness.
- Acts as the initial operational interface with externally managed/outsourced partners (e.g. CRO/ARO) and collaboration/alliance partners for program planning and delivery
- Ensure alignment of the clinical strategy, transfer of product knowledge and champion products that are between early and late stage organizations.
- Accountable for ensuring timely compliance with company wide governance controls (e.g. financial oversight, planning and control, continuous assurance, Clinical Trial Disclosure). Accountable for manage clinical plans (cost, FTEs and timelines) in business reporting systems.
- decision maker and escalation point with external partners and vendors for clinical delivery.
- Responsible for leadership and program management of non-drug project work as assigned, eg cross functional improvement initiatives
- Contribute to functional and cross functional initiatives as Subject Matter Experts
- Mentor, coach and support people development within Clinical Operations and other functions as appropriate
- Actively participate in networking both within and outside the therapeutic area, sharing best practises and lesson learnt
- Be early adopters for new ways of working and act as ambassadors for change, driving the implementation and utilization of new initiatives.
**Essential Requirements**:
- Bachelor of Science/Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred
- Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
- Extensive experience across the product life cycle with experience in late stage development and ideally across multiple therapeutic areas
- Clinical operations knowledge with strong track record of delivery
- Comprehensive knowledge of the clinical and pharmaceutical drug development process
- Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
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