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 segmentation 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 3x3 recruitment goals and has advanced knowledge in the field of country and site strategy and feasibility. 

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 segmentation 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 segmentation); 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 metrics.
• 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 through uptake of innovative strategies
• 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 delivery

QUALIFICATIONS / SKILLS

• BS / RN / MS & 7 years relevant experience
• PhD / MD and 3 years relevant experience
• Knowledge of Drug development, a thorough understanding of the processes associated with global country and site feasibility, clinical study start-up and business operations
• Experience in 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
• History of success in a customer service role with demonstration of meeting customer expectations.
• Strong verbal and written communication skills. Effective presentation and facilitation skills.
• Well-developed strategic planning, observation, analytical operational execution and problem-solving skills
• Strong business consultancy skills, including ability to persuade, negotiate, and moderate conflict
• Ability to multitask under tight deadlines on several projects with specific and unique requirements, while providing attention to detail and high quality work.
• Able to synthesize key messages pulling across multiple data sets

PREFERRED QUALIFICATIONS

• Experience in operations involving multinational clinical trials is preferred.
• Prior experience in global country and site feasibility preferred
• Able to make complex decisions that require assessing and choosing amongst multiple options, amidst competing priorities, and in ambiguous situations, to timelines and with available resource.
• Conversant with the long term strategy of the business and is able to leverage this in order to prioritize activities and answer key business questions.

ORGANIZATIONAL RELATIONSHIPS

• Reports to Category Aligned Head of Trial Feasibility and Site Intelligence
• Manages relationships with RU and BU Clinical leads, Asset Team Members (Asset Project Manager, Project Manager, Global Clinical Lead), Participant Recruitment, GSSO, Clinical Study Team Lead, and other roles within OARS
• Supports Pfizer Research and Development, Clinical Development & Operations, GSSO, and Patient Recruitment

 This is a Site based/Hybrid role

The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Medical

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