Robyn Griffith, BSN, MS, PMP

Experience

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  Quintiles

  Jan 2006 - Aug 2011

  Managed and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles. Ensured consistent use of study tools and training materials along with compliance with standard processes, policies and procedures. Implement continuous improvement activities for assigned projects. • Developed study management plans, together with team assignments and accountabilities and oversight of database maintenance. • Served as primary project contact with Sponsor to ensure communication maintained and continuously improved and reporting schedules adhered to. Show less

  • Senior Clinical Project Manager/Associate Director

    Jan 2008 - Aug 2011

  • Senior Clinical Team Lead

    Jan 2006 - Jan 2008
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  Covance

  Apr 2012 - Apr 2014

  Provided high-level oversight of a preferred partner Phase II-IV portfolio valued at over $100M dollars. The portfolio included studies ranging from early FIH trials to late-stage PASS, PMS, and compassionate use studies. Maintained relationships with assigned customers through quality project delivery while maintaining profitability. Oversaw global operations for portfolio within the preferred partnership. Managed the development of an operational strategy for clinical trial conduct and management of internal and external project or customer challenges. Show less Provided oversight and direction for multiple projects within a large pharmaceutical CRO. Responsibilities included developing and managing budgets, timelines, human resource and quality management plans, ensuring that deliverables are met while identifying and mitigating risks. Other responsibilities included supervising, assessing performance of core team members, along with motivating, training and developing the team's expertise to ensure efficient and effective day-to-day operations. Maintained strong client relationships are another priority of daily operations. Show less

  • Senior Director Project Management

    Jun 2013 - Apr 2014

  • Project Director

    Apr 2012 - Jun 2013
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  ICON plc

  Apr 2014 - Jun 2018

  Oversaw the management and leadership of the RWE-LP Americas operational team within the Real-World Evidence-Late Phase (RWE-LP) group, including Project Managers (PMs), Program Managers, and PM Directors. Cross-functional PMs/Directors were trained, directed, and assessed to meet full project timelines with quality and within budget. Managed and led Clinical Team Leads, Project Managers (PMs), Program Managers, and PM Directors within the General Medicine therapeutic area. Ensured cross-functional PMs/Directors were trained, directed, and assessed to meet full-service project or program timelines with costs under control, and any issues were mitigated/escalated as appropriate.

  • Senior Director Project Management, RWE-LP Regional Head of Operations

    May 2016 - Jun 2018

  • Senior Director Project Management

    Apr 2014 - May 2016
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  PPD

  Jun 2018 - Sept 2020

  Executive Director

  Provided strategic direction across therapeutic areas and other divisions across PPD to ensure a customized and effective biotech delivery model for a portfolio of clients. Provided consultation, direction, and leadership to functional and operational teams offering financial and operational excellence, consistency, quality, business development, innovation, and learning. Working alongside with business development colleagues, brought in $65M annually with strong backlog.

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  ICON plc

  Sept 2020 - Jul 2021

  Executive Director, Project Delivery

  Regional Head of Small/Midsize Biotech providing strategic direction to the biotech team and direct reports across all therapeutic areas. Created and maintained client relationships for both full and FSP contracts and secured new & repeat business through timely delivery of projects and quality data with a return on profit (P&L). Achieved functional goals by the company mission and objectives and delivered projects with technical competence and compliance. Developed financial training program for project managers across all therapeutic areas. Show less

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  INOVIO Pharmaceuticals, Inc.

  Jul 2021 - Sept 2023

  Led the operational strategy, planning, execution & completion of all clinical trials for the company. Therapeutic indications focus included oncology, rare disease, infectious disease and women's health. Ensured clinical science and operation activities executed in the most cost and time effective way, while assuring quality, GCP and ICH compliance and adherence to all applicable regulations. Additionally, oversaw the design and feasibility assessment of clinical protocols. Was accountable for Operational P&L, timelines, and outsourcing, including best practice vendor and consultant management in achieving deliverables. Led, developed, and coached a team of 45 highly effective clinical science and operation professionals. Team comprised of both full FTE and contract employees. Show less Oversaw and directed strategy, planning, outsourcing and execution of all clinical trials. Indications include oncology, rare and infectious diseases for both pediatric and adult subjects. Ensured clinical science and operation activities were executed cost/time-effective while assuring quality, GCP, and ICH compliance and adherence to all applicable regulations. Oversaw the design and feasibility assessment of clinical protocols. Accountable for P&L, timelines, outsourcing, best practice vendor, and consultant management in achieving deliverables. Led, developed, and coached a team of 18 clinical science and operation professionals. Further, identified need for SOP re-structure, identified and oversaw team to complete and re-train staff the new process. Show less

  • Vice President, Head of Global Operations

    Feb 2022 - Sept 2023

  • Vice President, Clinical Science and Operations

    Jul 2021 - Feb 2022
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  WuXi AppTec

  Feb 2024 - Aug 2024

  Head of NA/EU Clinical Operations

  Oversee operational, financial execution and completion of Phase I-4 global clinical trials, a sample of indications include oncology, rare disease, cardiovascular, pediatric indications. Within 3 months, partnered with business development team bringing in $15M revenue with additional $8M backlog. Further, I re-organized and established strong, clear reporting structure. Directed ClinOps team to develop clear reporting on utilization rate, forecasting and FTE requirements, resulting in decreased head count requirements & increased financial/operational efficiency. Show less