Summary
Overview
Work History
Education
Skills
Affiliations
Accomplishments
Certification
Community
Timeline
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Debra Oister

Pottstown,Pa

Summary

Senior leader with over 20 years of experience in the pharmaceutical industry. Expertise in leading global multi-disciplinary teams through drug development. Built a reputation on trust and strong work ethic which results in frequently being selected by senior leaders to leverage unique stakeholder skill to deliver high-profile, high-risk initiatives. Passionate about stepping into new roles and quickly making positive changes to drive company success. Known for being an organizational problem-solver with strong technical, strategic agility, communication, and relationship-building skills. Collaborative and results driven with an interest in helping teams change and thrive in challenging situations, ultimately leading organizations to the next level of growth.

Overview

21
21
years of professional experience
2
2
Certifications

Work History

Research & Development Operations

GlaxoSmithKline
Upper Providence
01.2019 - Current
  • Build strategy and execution plan for transformation projects to reduce cycle times and simplified processes
  • Navigate complex, matrixed environment to lead team to deliver results
  • Connecting the dots across the enterprise, considering how to optimize the impact as we seek to translate strategy into execution
  • Led strategy development and deployment for GSK’s Global Development Business Operations in Pharma R&D
  • Provided leadership to employees through coaching, feedback, building capabilities and performance management
  • Perform ad-hoc analysis, develop strategic options, and providing recommendations to enable informed decision making specifically in the areas of major investments, organizational setup, and productivity improvement (business case development, cost / benefit analysis, pro/cons, etc)
  • Synthesize all available business data into a clear message and theme
  • Developed corporate objectives and strategies collaborating on quality metrics and key performance indicators (KPI), as well as strategizing with cross-functional teams on improvement measures related to quality.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.

Chief of Staff Clinical Operations

GlaxoSmithKline
Upper Providence
01.2015 - 01.2019
  • Providing decision making support to, senior leadership team to make optimal long-term decisions and effectively drive change, specifically in the areas of major investments, organizational setup, and productivity improvement
  • Partner with leadership team on drawing out and prioritizing strategic questions and choices
  • Lead teams on abstract principles from findings, and translate back to actions
  • A key contributor to the development of strategic cross-R&D business capability enhancement funding proposal
  • Serve as business lead or provide change leadership and/or program management, as required, across the lifecycle of programs/projects, including new initiatives
  • Identifying and designing cross-therapy area initiatives and driving their delivery
  • Analyzed and solved multi-faceted problems that effected executive leaders and business initiatives.

Project Manager and Project Director

GlaxoSmithKline
Upper Providence
01.2004 - 09.2015
  • Developed and initiated projects, managed costs and monitored performance, to stay ahead of schedules and proactively spot potential roadblocks
  • Actively contributes to formation of project scope, development plans, Therapeutic Product Profiles, strategies, criteria for Go/No Go decisions and critical path(s) with the project team, with emphasis on contingency planning where appropriate
  • Ensures collaboration and communication between cross functional global project teams, decision-making bodies, and line function management to maintain alignment of project strategy, goals, team deliverables, while ensuring appropriate escalation of issues that may impact milestone deliverables (global and project level)
  • Supervised numerous projects throughout lifecycle, including planning, design and scheduling, resulting in cohesiveness and accuracy in completed assignments
  • Constructs and communicates the overall Development Plan budget across all functional areas to include annual budgets and updates as well as long range plan projections; routinely communicate budget status, variance, and impact to plan
  • Lead the European Marketing Authorization Application (MAA) and New Drug Submission (NDS) submissions and approvals of Volibris
  • Coordinates team activities during regulatory review period including responding to EU Assessment report(s), tracking various manufacturing inspections required for license
  • Alliance Management – Coordinates project-specific communications with Joint Venture partners for several programs
  • Deputized as sole project leader to represent project management on due diligence activities for two programs.

Data Quality Leader

GlaxoSmithKline
Upper Providence
11.2012 - 01.2014
  • Single point of accountability for data quality and integrity at the study level
  • Provide leadership and direction to Data Management team ensuring plans are adjusted and communicated as needed
  • Define timelines for dataset delivery to meet key milestones (includes IDMC reporting, data looks etc)
  • Lead in-stream data trend analysis in support of data quality and integrity
  • Lead database release planning activities, includes development of a study-specific Data Quality Release Plan
  • Demonstrated leadership by making improvements to work processes and helping to train others.
  • Followed quality standards and procedures to minimize errors and maximize delivery.

Education

Bachelor of Arts - Organizational Leadership

Cabrini University

Skills

Strategic planning and execution

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Affiliations

Innovation, Performance and Technology awards 2019, 2020 – award given to top 10% of organization Gold Awards 2020-2022 Leading and organizing the COVID Business Continuity Working Group Co Leading Integrated Resource Management Design and implementation of Strategic Resource Management Leadership of Accelerating Submission, Project Management Professional, PMP Prosci Community Volunteer for American Cancer Society Co-chair American Cancer Society Relay For Life of Pottstown 2010, 2011, 2012 CYO Volleyball Coach

Accomplishments

Innovation, Performance and Technology awards 2019, 2020 – award given to top 10% of organization

Gold Awards 2020-2022

Leading and organizing the COVID Business Continuity Working Group

Co Leading Integrated Resource Management

Design and implementation of Strategic Resource Management

Leadership of Accelerating Submission

Certification

Project Management Professional, PMP

Community

Volunteer for American Cancer Society

Co-chair American Cancer Society Relay For Life of Pottstown 2010, 2011, 2012

CYO Volleyball Coach

Timeline

Research & Development Operations

GlaxoSmithKline
01.2019 - Current

Chief of Staff Clinical Operations

GlaxoSmithKline
01.2015 - 01.2019

Data Quality Leader

GlaxoSmithKline
11.2012 - 01.2014

Project Manager and Project Director

GlaxoSmithKline
01.2004 - 09.2015

Bachelor of Arts - Organizational Leadership

Cabrini University

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Debra Oister