Associate Director - Feasibility Lead

ROLE SUMMARY

Partners withClinical 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.

Works under close supervision of Senior Director - Feasibility Group Lead to support therapeutic areas as needed.

ROLE RESPONSIBILITIES

• 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 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.

QUALIFICATIONS

In general, candidates for this job would have the following levels of experience in Clinical Research/Clinical Operations:

• BS/Equivalent - 4 years
• MS - 3 years
• PhD/MD - 2 years
• 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.

NICE TO HAVE:

• Oncology clinical operations experience.

Other Job Details: March 19th, 2021

• Last Date to Apply for Job:
• Eligible for Employee Referral Bonus: YES

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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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