Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Affiliations
References
Timeline
AssistantManager

Andrea Perrone

Philadelphia,PA

Summary

Dynamic leader with extensive experience at Merck Pharmaceuticals, excelling in financial management and metrics-driven risk management. Achieved significant savings through strategic resource allocation and integration leadership. Proven track record in regulatory compliance and fostering patient engagement, enhancing clinical trial outcomes across diverse therapeutic areas. During her tenure at Merck, she has supported over 100 approvals across all three therapeutic areas.

Overview

19
19
years of professional experience
1
1
Certification

Work History

VP, Clinical Study Management, Imaging & Path

Merck Pharmaceuticals
North Wales, PA
01.2024 - Current
  • Oversaw financial operations, managing $30 million budget for 1,200 staff and $2.5 million travel budget.
  • Strategic oversight on headcount forecasting for 2025, and sharing of resources across three therapeutic areas, achieving savings of approximately $9.5 million.
  • Executive Sponsor for the initiative to gather site and patient input for protocol design in compliance with new FDA guidance.
  • Launched Power Automate app to enhance communication between sites and sponsors.
  • Developed a tool to track early risk and mitigation efforts, along with metrics and goals tracking.
  • 2024 Portfolio - 285 active studies, 19,000+ active sites, and approximately 76,000 active patients across all three therapeutic areas. 93% (500/538) GCTO milestones achieved on time.
  • Appointed by the President of MRL to lead integration for the asset acquisition of Curon, CN201, a novel bispecific antibody for the treatment of B-cell-associated diseases in autoimmune and oncology (9 August 2024).

Associate VP, Clinical Study Management

Merck Pharmaceuticals
North Wales, PA
03.2019 - 01.2024
  • Oversaw financial operations for team of 850 people.
  • In 2023 Oversight of oncology portfolio 210 active trials, 15,000 active sites and 39,000 active subjects. 39 new studies; 31 assets.
  • Key collaborations: 10 with AZ, 16 Eisai, 20 SeaGen, 144 with Kelun, 6 with Moderna
  • Achieved greater than 93% metrics across GCTO on time.
  • Appointed by the President of MRL to lead integration for the Imago Biosciences acquisition (January 11, 2023). It entailed six trials to integrate: one in Phase 1, three in Phase 2, and two in Phase 50+ person organization with a talent harmonization and retention model.
  • Directly supported meetings across global Clinical Site Partners to share early insights and engagement in the oncology pipeline.

Associate Vice President, Head of Clinical Imaging

Merck Pharmaceuticals
West Point, PA
01.2017 - 02.2025
  • Established core principles, Key Performance Indicators and metrics for independent imaging core labs supporting oncology trial endpoints in collaboration with Merck's Portfolio and Relationship Management team.
  • Developed resources and job aids to define roles of clinical imaging scientists and leads.
  • Built a team of 11 professionals to enhance clinical imaging across all therapeutic areas at Merck.
  • Provided regulatory support for Keytruda filings for EMA sponsor inspections and meetings with the FDA (Keynote 001, 002, and 006).

Executive Director

Merck Pharmaceuticals
West Point, PA
09.2012 - 01.2019
  • Individual contributor within the Translational Medicine team as the sole radiologist.
  • Leveraged experience working with an imaging Core Lab to establish best practices to be a "Sponsor of Choice"
  • Developed a novel imaging criteria, 'iRECIST' along with the RECIST Working Group and presented at > 75 Investigator Meetings to enable 'treatment beyond radiographic progression'.

Head of Late Clinical Development

General Electric Healthcare
Princeton, NJ
04.2011 - 09.2012
  • Directed clinical oversight for development of CT and MRI diagnostic contrast agents.

VP, Global Clinical Operations

BioClinica (now called Clario)
Princeton, NJ
04.2006 - 04.2011
  • Delivered operational and clinical oversight for pharmaceutical and biotechnology clients conducting imaging-focused clinical trials.
  • Provided regulatory guidance across Phase 1-4 trials in oncology, musculoskeletal, neurology, rheumatology, and cardiology.
  • Facilitated compliance with industry regulations to ensure trial integrity and safety.

Education

M.D. - 4 year Radiology Residency

University of Pittsburgh
Pittsburgh, PA
07-1999

Some College (No Degree) - 1 Year Transitional Internship At Fairfax Hospital

Georgetown School of Medicine
Fairfax, VA
06-1995

M.D. - 4 Year Medical School

Georgetown University
Washington, DC
06-1994

Bachelor of Science - Finance

University of Maryland
College Park, MD
12-1987

Skills

  • Financial management
  • Metrics and Risk Management
  • People Leadership
  • Regulatory compliance and inspection support (interviewed by the EMA for the Keytruda sponsor inspection and FDA meetings in 2014)
  • Integration leadership requires leadership across an enterprise team of 12 corporate functions, tracking timelines, metrics, and communications to the executive suite
  • Process Improvement: launching MS Copilot and Center of Excellence
  • Patient/Site Engagement: via Clinical Site Partnerships and tools to streamline

Certification

  • Association of Clinical Research Professionals (ACRP) December 2024
  • California Medical License- retired
  • Johns Hopkins Management Program 2017
  • Harvard Build the Best Teams Program (Perlmutter) 2016
  • Wharton Management and Engagement Foundations 2015
  • Coaching Conversations/Change Acceleration GE Healthcare 2011

Accomplishments

  • Division Award from Joe Milletich for contributions to MK3475 2015, 2017, 2018
  • Division Award from Rupert Vessey for contributions to Keytruda Approval 2014
  • Special Achievement from Frank Clyburn in support of ASCO 2014
  • Special Achievement from Roger Perlmutter in support of PD-L1 2013

Affiliations

  • Steering Committee for Senior Women's Leaders (2024-2025
  • Steering Committee for Oncology Women Leaders (OWL) 2019- 2024
  • RECIST Working Group October 2016- 2018
  • American Society of Clinical Oncology 2012 - 2019
  • Quantitative Imaging Biomarker Alliance 2012- 2014

References

References available upon request.

Timeline

VP, Clinical Study Management, Imaging & Path

Merck Pharmaceuticals
01.2024 - Current

Associate VP, Clinical Study Management

Merck Pharmaceuticals
03.2019 - 01.2024

Associate Vice President, Head of Clinical Imaging

Merck Pharmaceuticals
01.2017 - 02.2025

Executive Director

Merck Pharmaceuticals
09.2012 - 01.2019

Head of Late Clinical Development

General Electric Healthcare
04.2011 - 09.2012

VP, Global Clinical Operations

BioClinica (now called Clario)
04.2006 - 04.2011

M.D. - 4 year Radiology Residency

University of Pittsburgh

Some College (No Degree) - 1 Year Transitional Internship At Fairfax Hospital

Georgetown School of Medicine

M.D. - 4 Year Medical School

Georgetown University

Bachelor of Science - Finance

University of Maryland
Andrea Perrone