Pfizer Associate Director in Collegeville, Pennsylvania
Partners with CROs and Clinical Operations to develop and deliver rapid, accurate and robust assessments of program and country feasibility, oversight of site identification/site feasibility, and timing of key start-up and recruitment milestones. Focusing on data driven estimates, benchmarking assumptions, robust scenarios & accurate planning.
This colleague will work under close supervision of Senior Director, Feasibility Group Lead to support therapeutic areas as needed (i.e. therapeutic area agnostic).
Supports and Manages processes relating to Program, Protocol, Country & Site feasibility
Supports Patient Recruitment Plans in collaboration with Patient Recruitment Strategy Group
Supports Protocol Optimization Strategies
Participates in global initiatives to improve operational efficiencies
Supports Clinical Operations in the build of data driven study assumptions from operating plan to study work order
Support/advise the Site Identification and Site 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, responsible for delivery of 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 CROs
Partner with CROs to build system, processes and work practices that drive rapid, accurate and robust assessments of program, country and protocol feasibility (country, site) as well as the timing of key recruitment milestones.
Support the development of data driven study / program assumptions.
Support governance processes by providing early feasibility information leveraging existing data sources and organizational knowledge/expertise
Partners with CROs, Clinical Operations 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
Feasibility experience is not required, in depth training will be provided
In general, candidates for this job would have the following levels of experience in Clinical Research/Clinical Operations:
Bachelor's Degree or Equivalent and 4 years of experience
Master's Degree and 3 years of experience
PhD or MD and 2 years of experience
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
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
Well-developed strategic planning, observation, analytical operational execution and problem-solving skills
Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict
Technical Skill Requirements
Demonstrated knowledge of clinical research processes and regulatory requirements.
Demonstrated success/results in prior roles including matrix organization
Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies
Demonstrated ability to manage projects and cross-functional processes required
Demonstrated platform skills; experience presenting to non-science populations
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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Additional Job Details
- This position may also sit in at a Pfizer location in France, Spain, United Kingdom, Mexico, Canada, Chile as long as there is a 1/2 day overlap in time zones with Collegeville, PA, United States
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.