Strategic Feasibility Director
Vor 3 Tagen
CSL is seeking a highly skilled Associate Director, Global Feasibility to join their team. This role offers an exciting opportunity to be part of a continually growing team dedicated to the end-to-end feasibility and study start-up delivery.
The Associate Director, Global Feasibility, is the strategic interface with Clinical Development and Clinical Portfolio Execution to provide quality-by-design/strategic insight on protocol and country early feasibility and build allocation strategy scenarios in line with budget.
The role is also the primary interface with the Global Medical Affairs and Commercial Development organizations to ensure country input into the country strategy and works closely with other functional area leads to ensure global consistency.
The role will provide leadership to the feasibility and start-up team across all clinical programs in accordance with the company strategy, timelines, budget, and quality expectations.
This role will collaborate closely with the site management team and site partnership to build a strong global site network and collaborate with the external service providers and site management group to develop a feasibility, start-up, and study enrolment strategy with appropriate mitigation to meet the study and program target within timeline.
Main Responsibilities and Accountabilities
- Accountable for the development of the feasibility strategy across clinical programs and delivering its end-to-end process.
- Lead and manage the global feasibility and collaborate with internal functional area leads (e.g. Regulatory Affairs, Clinical Vaccine Group) to build knowledge on study and country interest and feasibility and help to respond to the external environment.
- Pro-actively improve cross-business collaboration and leverage site relationships, data analytics, and internal cross-functional knowledge/expertise to build intelligence.
- Leverage historical, scientific, epidemiologic, and competitive data to identify and evaluate new regions/countries in line with the company strategy and in collaboration with Global Medical Affairs and Commercial group.
- Collaborate with the Program Director/Clinical Science & Strategy and Global Clinical Program Manager to provide analyses and data for scenario planning and country strategy, including region/country identification and evaluation.
- Ensure effective collaboration with external service providers to further 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. Establish, implement, and manage standards and processes for initiating study planning and feasibility activities, including build of data-driven study assumptions from protocol go through feasibility completion.
- Full support of the feasibility process. Maintain continuity across studies by documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, 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 at both the country and site level, as well as the timing of key recruitment milestones. Involve relevant stakeholders in the feasibility process to ensure all needs are considered and realistic study enrolment plans are developed and in place. Review and Implement tools or systems to streamline the feasibility process with stakeholders.
- Upholds and promotes the Company's reputation externally by demonstrating high professional standards and integrity in all external contacts.
- Maintains up-to-date knowledge of the Study Operations landscape, industry best practices, and regulatory considerations.
Background Education and Past Experience
- BS/BA degree required - Graduate degree desirable in a relevant field such as Operations, analysis, healthcare, 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 records 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, PowerBI
- Experience in overseeing complex and multi-regional Global Clinical Trials
Our Benefits
We encourage you to make your well-being a priority. It's important and so are you.
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