Sean M.

About Sean M.

Clinical development professional with expertise in the end-to-end scientific and operational management of Phase oncology trials with strong experience across both solid tumor and hematologic malignancies, with a focus in gastrointestinal indications (HCC/CRC). Over 15 years’ experience in both large and small pharmaceutical and contract research organizations with positions of increasing responsibility. Demonstrated capability leading trials from first-in-human evaluations through registrational trials supporting BLA/sBLA filings which resulted in securing additional indications in multiple markets and successful approvals of NMEs.Consistently recognized by peers and senior leaders for quality, speed, leadership, and innovation. Possesses an extensive working knowledge of GCP and ICH regulations as well as an in-depth command of project management principles contributing to high-quality clinical trial execution. Broad clinical development experience includes protocol development from design concept through governance and regulatory approval; informed consent authoring; case report form development; contributions to clinical development plan iteration and asset lifecycle management; preparation for and presentation to data monitoring and study steering committees; publication and scientific communication plans; planning and responding to health authority inquiries and inspections; developing and providing training; and oversight of data quality including defining data review strategies, planning and executing database locks, and clinical interpretation of results. Demonstrated ability to drive all aspects of trials operations including project planning and resourcing efficiently and effectively; identification, training, and coordination of clinical sites; budget development and management; coordination of cross functional teams including accountability for medical, biostatistics, clinical pharmacology, biometrics, QA, etc; and general responsibility for all aspects of trial conduct.

Experience

1. Associate Director, Senior Clinical Scientist Late Clinical Global Drug Development

   Bristol Myers Squibb

   Oct 2021 — Present

Education

• The George Washington University School of Medicine and Health Sciences

  MS, Clinical Research

  2012 — 2014

• Rochester Institute of Technology

  BS, Biotechnology

  2003 — 2007

• University of Medicine and Dentistry of New Jersey

  Cell & Molecular Biology

  2007 — 2008