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Feasibility Lead (Director)

Employer
Pfizer
Location
Collegeville, Pennsylvania
Salary
Competitive
Closing date
Dec 8, 2020

View more

Discipline
Health Sciences, Medicine
Position Type
Full Time
Job Type
President/CEO/Director/VP
Organization Type
All Industry, Pharma
ROLE SUMMARY

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 for assigned therapeutic area.

Supports Study Optimization Leadership/Feasibility Group Lead on special projects.

Leads and/or participates in global initiatives to improve operational efficiencies.

Supports the training and development of Feasibility Leads within assigned therapeutic area.

Works independently with minimal supervision.

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
  • Directly 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, drives 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 Clinical Operation Group Heads, 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.
  • Coordinate organizational resources to support build 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
  • management and delivers cost savings as required
  • 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
  • Leverages knowledge as subject matter expert and through process ownership drives concepts and theories within CD&O


QUALIFICATIONS

In general, candidates for this job would have the following levels of experience in Clinical Research/Clinical Operations:
  • BS/Equivalent - 10 years
  • MS - 8 years
  • PhD/MD - 6 years
  • Atleast 4-6 years of leading complex cross functional teams as well as managing teams
  • 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.
  • 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
  • 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 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


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.

Other Job Details:
  • Eligible for Employee Referral Bonus


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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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