Feasibility Strategy & Analytics Lead (Sr. Manager)

JOB SUMMARY:

The Feasibility Strategic Analytics Lead (FSAL) (Sr. Manager) will be responsible for partnering with Clinical Study Team Lead (CSTL), Participant Recruitment (PR), GSSO roles, and Clinical Leads to enable the predictable delivery of Pfizer’s portfolio by providing rapid, accurate and robust assessments of program and protocol feasibility, recruitment enrollment assumptions, and site strategy plans. This individual will provide the study team with robust scenario planning to inform and finalize an optimized country, site and enrollment study enrollment plan by leveraging data driven estimates, benchmarking assumptions, competitive intelligence, indication level knowledge, internal and external data sources, and the site predictability engine. This individual drives country and site selection for PTA for the study plan and leads the delivery of sites endorsed for Pre Trial Assessment for the study through the
planning of the optimal country and site footprint taking into consideration site classification strategies.

At the Sr. Manager level, the FSAL provides the study team recommendations on country and site selection, develops ideas to bridge the gap between evidence driven assumptions and recruitment goals and has advanced knowledge in the field of country and site strategy and feasibility. They bring analytical expertise and innovative approaches to streamline feasibility assessments, ensuring decisions are data-driven and aligned with company goals. This position requires a deep understanding of the clinical trial landscape and the ability to provide strategic input into the design and execution of feasibility studies. By identifying opportunities for process improvement and influencing crossfunctional teams, this role contributes to the continuous enhancement of the feasibility process, supporting the delivery of high-quality, efficient clinical trials.

JOB RESPONSIBILITIES:

• The Feasibility Strategy & Analytics Lead (FSAL) is the OARS single point of contact for the study team in the build of evidence driven study assumptions to provide a country and site strategy that includes a list of proposed countries and sites to be targeted during site feasibility/selection, enrollment scenarios, and protocol optimization strategies. FSALs will continue to support study team enrollment to assess future changes to that strategy (e.g. plan adjustments or rebaseline) through the completion of participant recruitment
• Implementing processes related to country & site intelligence and provide continuity by connecting and documenting changes throughout the lifecycle (from early estimates, early feasibility, detailed assumptions, detailed feasibility, to participant recruitment, study start-up planning and last subject first visit)
• Provides early feasibility (before core protocol elements are available) by providing initial enrollment timelines, potential country footprint, primary intelligence gathering (benchmark studies, competitive landscape, treatment approvals etc), and key enrollment assumptions to inform initial high level Op Plan assumptions Introduces opportunities for protocol optimization by leveraging real world data, investigator insights, patient insights, protocol simulations, and coordinates with relevant functions to incorporate these insights in study assumptions.
• As protocol elements evolve to final protocol and start up stages, the Feasibility Strategy & Analytics Lead (FSAL) will continue to evolve detail on country footprint, enrollment assumptions, and appropriate site classification strategy
• Support the build of the investigator database, collection of information supporting the definition of the ideal site for a study, identification of suitable sites for a study, and coordinate global efforts for site intelligence
• Author and maintain oversight of both Country and Site Feasibility outreach and engagement, lead response reviews with appropriate study team members, and provide strategic input into team decision making
• Analyze results of outreach and evidence to build the recommended country and site strategy
• Provide summary site analytics as the volume of sites is progressed through evaluation stages to Pre Trial Assessment (PTA) to ultimate Site Selection. Analytics include modeling volume of patients (by site classification); ability of site mix to achieve clinical trial diversity goals; competition, site overlap and other key parameters identified as performance drivers by study team
• Leveraging the totality of data available (internal, external and regional intelligence), provide strategic scenarios based upon team input and request, to team on options and levers to optimize site footprint and enrollment timelines
• Partners with CD&O teams, and RU/BU partners to improve overall study start up and recruitment cycle time m