Director, Feasibility Lead will be responsible ror partnering with Clinical Operations, Clinical Lead and CRO to help enable the predictable delivery of Pfizer’s portfolio. The candidate will be responsible for driving rapid, accurate and robust assessments of program and protocol feasibility as well as the timing of key start-up and recruitment milestones. Focusing on data driven estimates, benchmarking assumptions, robust scenarios & accurate planning.
• Directly supports the Clinical Operations in the build of data driven study Assumptions from operating plan to study work order,
• Support/advise the AP/CRO Feasibility Process
• Maintains continuity connecting and documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment & Start Up Planning
• In support of Clinical Operations, drives early feasibility (before core protocol elements are available)
• Support Clinical Operations roles early in the development cycle , providing initial enrollment timelines, High Level Budget (Op Plan), potential Country Footprint, develop key assumptions.
• Support Clinical Operation roles in Optimizing Operational Protocol Design
• Support Clinical Operation roles in ensuring effective scenario generation & planning; comparing Pfizer’s past performance data and proposed scenarios from AP’s/CRO
• Partner with Clinical Operation Group Heads, Alliance Partners and CROs to build system, processes and work practices that drive rapid, accurate and robust assessments of program and protocol feasibility (country, site) as well as the timing of key recruitment milestones.
• Operational accountability for ensuring effective scenario generation & planning comparing Pfizer’s past performance data and proposed scenarios from AP’s/CRO
• Coordinate organizational resources to support build of data driven study / program assumptions.
• Support governance processes (OpCo) by providing early feasibility informaion leveraging existing data sources and organizational knowledge/expertise
• Partners with Alliance Partners, Global Head of SSU, DevOps teams, and RU/BU partners to improve overall study start up metrics and implement simple processes.
• Operational responsibility for delivering to agreed set of KPIs for assigned protocols.
• Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivity
• Ensures accurate resource forecasting, budget management and delivers cost savings as required
• Influences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologies
• Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio deliverySetting Patient Recruitment Strategy for Pfizer’s portfolio
• Conduct Patient Recruitment Needs Assessment in conjunction with Study Teams for PFE development programs
Qualifications
• A broad based experience clinical research, including clinical trial conduct, Knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations
• Experience of managing multinational clinical trials is preferred.
• Experience in assessing Patient Recruitment Needs and building patient recruitment strategies for programs is highly desired
• Leadership, project/resource management (project, staff, finances), administrative, and technical capabilities are required.
• History of success in a customer service role with demonstration of meeting customer expectations.
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization
• Knowledge of Drug development, a thorough understanding of the processes associated with Feasibility, clinical study start-Up and business operations
• Well-developed strategic planning, observation, analytical operational execution and problem-solving skills
• Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict
• In general, candidates for this job would have the following levels of experience:
- BS/RN/ MS – 10 years
- PhD/MD – 6 years
• Technical Skill Requirements
• Demonstrated knowledge of clinical research processes and regulatory requirements.
• Demonstrated success/results in prior scientific/administrative management roles including matrix organization
• Preferred experience of directly managing a team least with direct accountability for performance/or with a direct customer relationship responsibility
• Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies
• Demonstrated ability to manage complex projects and cross-functional processes required
• Demonstrated platform skills; experience presenting to large non-science populations
• Understands & has demonstrated ability to manage large and complex budget; history of staying on or under budget
• Demonstrated knowledge of clinical research processes and regulatory requirements.
• Demonstrated success/results in prior scientific/administrative management roles including matrix organization
• Demonstration of success of managing a large Area/regional, project or line
• Preferred experience of directly managing at least 1 major Area/region with direct accountability for performance
• Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies
• Demonstrated ability to manage complex projects and cross-functional processes required
• Demonstrated platform skills; experience presenting to large non-science populations
• Understands & has demonstrated ability to manage large and complex budget; history of staying on or under budget
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