The Feasibility Strategic Analytics Lead (FSAL) (Senior Manager) will be responsible for partnering with Clinical Study Team Lead (CSTL), Participant Recruitment (PR), GSSO roles, and Clinical Leads 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. These individual drives country and site selection for Pre Trial Assessment (PTA) for the study plan and leads the delivery of sites endorsed for PTA for the study through the planning of the optimal country and site footprint taking into consideration site classification strategies.

At the Senior 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 cross functional teams, this role contributes to the continuous enhancement of the feasibility process, supporting the delivery of high-quality, efficient clinical trials.

Job Description

• 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. latest estimates or rebase line) 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 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 metrics.

• Operational responsibility for delivering to agreed set of KPls 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.

At an above study level, focused on:

• Establish and maintain a portfolio aligned "living library" of knowledge that is continuously updated as evidence and intelligence evolves over time

• Provide re-occurring assessment of comparator studies and key trial metrics such as country experience, site access, randomization rates, retention rates and protocol insights such as commonly used trial inclusion / exclusion criteria, # of endpoints etc.

• Analysis of program / indication level real world data, standard of care, recruitment rates, and evidence to profile geographic disease prevalence rates and insights on appropriate care settings for specific patient populations that can be translated into future site requirements for individual clinical trials.

• Partner with the OARS/GSSO teams to develop intelligence on preferred sites for the disease indication, in alignment with site classification strategy (strategic sites, high volume sites, diverse population sites etc.). Continually evaluate overlapping sites within indication and make above study recommendations when additional (naive) sites need to be factored into site selection; influence stakeholder decision making and uptake of naive sites

• Analyze Decentralized Clinical Trial (DCT) applications to fully understand DCT options as they relate to countries and sites (uptake, performance etc). Inventory of historically used DCT strategies and impact within disease indication (e.g., decentralized trials). Recommendation of category appropriate strategies, influence stakeholder decision making and uptake of DCT strategies where applicable within Category.

• Evaluation of assets within Pfizer's early-stage portfolio to begin preparations of Knowledge Library in advance of formal trial feasibility engagement.

• Partnership with Platform Analytics Lines within OARS to outline custom internal/external data needs to support emerging disease indications

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.
• Oncology experience is preferred.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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