Senior Director - Feasibility Group Lead Inflammation & Immunology

Employer
Pfizer
Location
New York City, New York
Posted
Oct 06, 2021
Ref
4827244
Discipline
Science/R&D, Immunology
Required Education
Associate Degree
Position Type
Full time

ROLE SUMMARY

Partner with CD&O, GSSO and CRO’s to drive 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.


Lead as a player/coach Feasibility Leads in Inflammation & Immunology

Responsibilities:

  • Directly supports the GSSO in the build of data driven study Assumptions from operating plan to study work order,

  • Support/advise the CRO 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 GSSO drives early feasibility (before core protocol elements are available)

  • Support GSSO roles early in the development cycle , providing initial enrollment timelines, High Level Budget (Op Plan), potential Country Footprint, develop key assumptions.

  • Support GSSO roles in Optimizing Operational Protocol Design

  • Support GSSO roles in ensuring effective scenario generation & planning; comparing Pfizer’s past performance data and proposed scenarios from CROs

  • Partner with CD&O/GSSO Group Heads and CROs 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.

  • Operational accountability for ensuring effective scenario generation & planning comparing Pfizer’s past performance data and proposed scenarios from CROs

  • 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, GSSO 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

  • Ensures accurate resource forecasting, budget 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

  • Lead as a player/coach Feasibility Leads in Inflammation & Immunology

QUALIFICATIONS

  • 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 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
  • In general, candidates for this job would have 15+ years of experience in Clinical research with 6-8 years of leading complex cross functional teams as well as managing teams
  • 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.

This role can be remote based.

#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.

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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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