Colleen S.

About Colleen S.

I am a Chief Risk Architect in Healthcare AI with 25 years of experience leading clinical operations, including direct responsibility for clinical trial implementation, protocol execution, and real-world deployment across oncology and complex disease.Over the course of my career, I’ve built, scaled, or advised 20+ startups spanning healthcare, biotech, AI, and clinical infrastructure. I’ve worked at the intersection where promising science either becomes patient impact—or quietly fails.What defines my work is not discovery hype, but clinical accountability.I design AI systems that operate before failure: • identifying which patients are likely—and unlikely—to respond • modeling durability, immune escape, and toxicity risk over time • engineering clinical trials as adaptive systems, not static protocols • producing regulator-grade, clinician-interrogable evidenceI am the inventor of pending patents focused on AI-driven clinical trial determination and patient selection, built to reduce late-stage failure by stress-testing trials before the first patient is enrolled.This work is personal. I’ve lost my sister, mother, niece, and sister-in-law to cancer. Those experiences shaped how I think about risk, timelines, and what “success” actually means in medicine.Patients don’t experience failure as a statistic. They experience it as lost time.My goal is to turn clinical development from a game of chance into an engineering discipline grounded in human reality—so fewer patients are asked to carry the cost of our uncertainty.I work with founders, clinicians, and investors who are serious about solving the real bottleneck in medicine: proving what works, for whom, and why—before it’s too late.

Experience

1. Chief Compliance Officer

   Physician\'s Managed Services

   Jan 1996 — Present

   I maintain a deep understanding of the healthcare regulatory landscape, including laws related to patient privacy, medical billing, and healthcare fraud and abuse. I work closely with other senior leaders, including the CEO and the Board of Directors, and physicians to inform and advise on compliance matters, risk assessment, and ethical practices. I convey compliance issues across all levels of our organization, from executive leadership to frontline staff. This involves disseminating information and fostering a culture of compliance and integrity. I try to lead by example, promoting an organizational culture that values ethical conduct and compliance with legal and regulatory standards which is integral to our success. I am the lead investigator on all compliance concerns or breaches, and I initiate corrective actions when necessary. I am extremely meticulous and unbiased throughout the process. I stay in constant communication with the personnel involved, maintaining full transparency and accountability at every step. I assess potential compliance risks and I develop the strategies to mitigate these risks making sure that our policies and procedures in place are regularly reviewed and updated to reflect the changing regulatory environment. I develop and oversee training on-going programs that educate employees about compliance policies, ethical conduct, and regulatory requirements. I am committed to ensuring that my organization complies with external regulations and upholds the highest standards of internal ethical conduct. I see this responsibility as a fundamental component to the trust and credibility of the my organization in the eyes of patients, staff, and the broader community.

Education

• Harvard Business School Online

  Healthcare Economics, Business/Healthcare

• National Laser Institute

  Safety Officer, Quality Control and Safety Technologies/Technicians

• National Institute of Health and Human Services

  Licentiate degree, Health Information/Medical Records Administration/Administrator

• MIT Sloan School of Management

  Applied Business Analytics

• Harvard Medical School

  Artificial Intelligence in Healthcare , Artificial Intelligence in Healthcare: From Strategies to Implementation

• Harvard Medical School

  Leading Digital Transformation in Healthcare

• Texas Tech University Health Sciences Center Graduate School of Biomedical Sciences

  Business Administration and Management, General