Feasibility Lead (Associate Director)

What You Will Achieve

The Feasibility Lead will be responsible for partnering with CD&O and GSSO colleagues 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.

Works under close supervision of Senior Director - Feasibility Group Lead to support therapeutic areas as needed (i.e. can be therapeutic area agnostic).

How You Will Achieve It

• Directly supports the build of data driven study Assumptions from operating plan to study work order,
• Support/advise the 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 CD&O, drives early feasibility (before core protocol elements are available)
• Support CD&O roles early in the development cycle, providing initial enrollment timelines, High Level Budget (Op Plan), potential Country Footprint, develop key assumptions.
• Support CD&O roles in Optimizing Operational Protocol Design
• Guides Patient Recruitment Plans in collaboration with the Patient Recruitment Strategy Group
• Support/advise the Site Identification and Site Feasibility process
• Operational accountability in ensuring effective scenario generation & planning, comparing Pfizer's past performance data
• Partner with CD&O and GSSO team 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.
• Coordinate organizational resources to support build of data driven study / program assumptions.
• Support governance processes (SciOps) by providing early feasibility information leveraging existing data sources and organizational knowledge/expertise
• Partners with CD&O 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
• 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,
• Participates in global initiatives to improve operational efficiencies

Qualifications

Must-Have

• 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 - 4 years
  • MS - 3 years
  • PhD/MD - 2 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

Eligible for Employee Referral Bonus: YES

#LI-PFE

#LI-Remote

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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