Clinical Team Operations Leader, Associate Director (Remote)
The PDO Clinical Team Operations Leader (CTOL) reports to the Clinical Team Operations Director (CTOD) and supports the execution of the clinical operations strategy as defined by the Clinical Development Plan (CDP). The CTOL brings best in class project management capability to expedite key operational processes that include integrated clinical planning, governance/budgeting, resource management, cross-program risks and scenario planning. The CTOL partners with the Global Program Leader (GPL) to deliver the operational strategy according to quality, timeline, and budget goals set forth by the Compound Development Team (CDT).
Partner with the GPL to expedite the management of clinical operational deliverables through application of integrated planning, best practices and project management capability.
Work with study level leads to capture, track and manage cross-program risks and issues and implement appropriate mitigation strategies.
Develop expertise on R&D and relevant TA governance processes and collaborate with clinical leaders and study managers to prepare deliverables required by associated stage-gate and TA Review Board processes and deliverables.
Build and maintain processes that will track and organize historical governance decisions and budget approvals as a resource to inform future governance planning efforts.
Support the GPL and Clinical Team to assist in the management of late-stage program processes including LTE transition and program closeout activities.
Partner with government and external partners to satisfy clinical objectives and advance the program as required.
Develop new CTOL capability and assist in the collection and dissemination of best practices that can be leveraged across the portfolio.
Support clinical teams by becoming a “trusted advisor” to project leadership and functional team members.
Assist GPL in making informed and timely decisions by applying specific combination of relevant experience, project management expertise, and leadership capabilities to facilitate clinical program execution.
Leverage expertise in project management tools and techniques, support the generation of project plans and provide insights based on customized project analysis and scenarios.
Bring clarity and focus to key clinical activities through critical path analysis; work with PMO partners to ensure alignment and integration with CDT project plans in Planisware.
Identify and communicate potential gaps in current cross-departmental processes and organizational structures and work with line management to remove obstacles to effective project execution.
Proactively recommend and outline new processes for upcoming and current clinical development phases. Help integrate enabling technologies into the team setting to drive clarity and efficiency.
Actively monitor and engage internal/external partners to ensure a constant awareness of emerging new practices, project management and leadership tools and strategies, and continuous improvement opportunities for CTOLs.
Primary interfaces: Global Program Leaders, Global Trial Leaders, Program Management Leaders, Program Coordinator, Clinical Trial Leaders
Contacts inside the company include but are not limited to:
Global Operations Head, Members of Compound Development Team, Finance, and Cross functional leads
Contacts outside the company:
vendors’ contacts as applicable, including CROs and external business partners as needed
Education and Experience Requirements:
A minimum of a Bachelor’s Degree or equivalent work experience is required, Post-Graduate degree in Project Management or Business is preferred
A minimum of 5 years industry/CRO/business experience is required in clinical drug development and/or clinical operations required.
A minimum of 3 years of hands-on Project Management experience is required.
Professional project management certification (i.e. PMP, CPM, etc.) is preferred.
Demonstrated proficiency in MS Project is required.
Prior experience leading cross-functional global teams is required.
Demonstrated ability to resolve conflict and influence teams without direct authority is required.
Successful experience in planning and management of governance processes is required.
Proficiency with technology-enabling tools including Visio, Excel required.
Demonstrated ability to be creative and flexible to change/improve working environment in broad context is required.
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