Strategic Associate Director, Global Feasibility and Delivery
4 days ago
The Associate Director, Global Feasibility and Operations, is a key member of the CSL Behring team, responsible for providing strategic insight and leadership to the feasibility and start-up process across all clinical programs. This role requires a dynamic and analytical individual with outstanding communication skills and the ability to drive assessments and intelligence to inform strategic decisions.
Main Responsibilities- Develop and implement a feasibility strategy across clinical programs, ensuring alignment with company strategy, timelines, budget, and quality expectations.
- Lead and manage the global feasibility team, collaborating with internal functional area leads to build knowledge on study and country interest and feasibility.
- Proactively improve cross-business collaboration and leverage site relationships, data analytics, and internal cross-functional knowledge to build intelligence.
- Leverage historical, scientific, epidemiologic, and competitive data to identify and evaluate new regions/countries in line with the company strategy.
- Collaborate with the Program Director/Clinical Science & Strategy and Global Clinical Program Manager to provide analyses and data for scenario planning and country strategy.
- Ensure effective collaboration with external service providers to build feasibility and country strategy for a given study, including mitigations for enrolment.
- Ensure oversight of the enrolment strategy and mitigations until the study has completed enrolment.
- Ownership of the Feasibility Mobilization process, establishing, implementing, and managing standards and processes for initiating study planning and feasibility activities.
- Full support of the feasibility process, maintaining continuity across studies by documenting changes from Early Estimates to Recruitment & Start Up Planning.
- Partner with Clinical Operations management to implement processes and work practices that drive rapid, accurate, and robust assessments of program and protocol feasibility.
- Uphold and promote the Company's reputation externally by demonstrating high professional standards and integrity in all external contacts.
- Maintain up-to-date knowledge of the Study Operations landscape, industry best practices, and regulatory considerations.
- BS/BA degree required - Graduate degree desirable in a relevant field such as Operations, analysis, healthcare, or MBA.
- 10+ years of Clinical Operations experience, including detailed assessment/analysis and reporting of program operational plans and options.
- Experience in overseeing complex and multi-regional Global Clinical Trials.
- Track record of strategically advising leaders on operational environment and best ways to succeed in plan execution.
- Track record of using diverse datasets for purposes of analysis and intelligence.
- Demonstrated proficiency in advanced MS Project, Microsoft Word, and PowerBI.
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