“Sometimes disappointing others is crucial to be true to yourself.”
Michelle Mack-Williams is a highly respected clinical research professional with over two decades of experience advancing pharmaceutical development and healthcare innovation. As a Senior Clinical Project Associate at Bristol Myers Squibb, she brings to the forefront a rare combination of strategic insight, operational discipline, and human-centered leadership that has shaped the success of numerous global clinical trials.
Michelle’s journey spans more than 24 years across industry-leading organizations including Karuna Therapeutics, GSK, AstraZeneca, PPD, and Premier Research. Her career reflects a deep commitment to improving patient outcomes through meticulous trial coordination, cross-functional collaboration, and a passion for mentorship. Throughout her tenure, she has supported clinical operations across multiple therapeutic areas and all phases of drug development—from feasibility to closeout—earning a reputation for dependability and transformative project impact.
At Karuna Therapeutics, Michelle led pivotal contributions in trial documentation and regulatory compliance, implemented streamlined SharePoint systems, and helped shape clinical trial budgets and reports presented at major scientific meetings. Previously at GSK, she initiated patient-focused educational programs in collaboration with advocacy groups, championed SOP compliance, and orchestrated investigator meetings that fortified trial integrity and engagement. Her innovative mindset also surfaced at GSK, where she developed a PK tracker for streamlined endpoint analysis and designed training programs that improved research associate performance metrics by 20%.
Michelle’s foundational years at AstraZeneca, where she served for nearly 15 years, saw her coordinating complex operational workflows, launching a global recognition program, and collaborating on a youth-focused initiative with the United Way—illustrating her belief in purpose-driven work that extends beyond the lab.
A true systems thinker, Michelle is adept in an array of platforms critical to clinical trial success, including Veeva Vault, eTMF, SAP, Concur, RAVE, and IMPACT. She is also known for creating tailored solutions such as clinical SharePoint databases and study-specific trackers that elevate compliance, clarity, and team productivity.
Michelle holds a Bachelor of Science in Health Administration from the University of Phoenix and an MBA in Healthcare Administration from Argosy University. Her educational background reflects a lifelong dedication to professional growth and effective leadership in healthcare.
Beyond her technical skillset, Michelle is a dynamic communicator and mentor. She has trained and guided clinical teams, supported regulatory inspections, and contributed to multiple educational series to help bridge gaps between scientific research and clinical application. Her ability to translate complex clinical operations into clear, actionable strategies makes her an invaluable resource to colleagues, sponsors, and stakeholders alike.
Michelle’s professional excellence is underscored by a sincere commitment to inclusion, integrity, and the well-being of both patients and professionals in the healthcare ecosystem. Though the record does not reflect formal board appointments to date, her leadership legacy—within teams, programs, and across major pharmaceutical environments—is indisputable.
In every role, Michelle Mack-Williams exemplifies what it means to be a steady force in a fast-moving industry: analytical, compassionate, solutions-driven, and above all, dedicated to progress that matters.
Character
Michelle Mack-Williams exemplifies integrity, perseverance, and a deep commitment to improving healthcare outcomes through her 24-year journey in clinical research, consistently showing up as a dependable leader and advocate for both patients and professionals.
Knowledge
With a robust background in clinical operations across top pharmaceutical organizations, Michelle brings expert-level proficiency in trial coordination, regulatory compliance, systems like Veeva Vault and RAVE, and a deep understanding of therapeutic areas and study phases from feasibility to closeout.
Strategic
Michelle identifies and implements process improvements that streamline operations and enhance performance, such as developing clinical data trackers, optimizing document systems, and designing educational programs that elevate team capabilities and trial effectiveness.
Communication
A skilled communicator in both written and oral formats, Michelle builds trust and clarity across cross-functional teams, mentors junior staff, engages advocacy groups, and presents clinical data with precision and purpose to diverse stakeholders.
