Lyn Agostinelli brings over 33 years’ experience in the life science industry and clinical practice as a registered nurse. She has extensive experience managing clinical programs in pharmaceutical and device companies. Lyn has proven clinical and project management skills in both industry and academic settings, as well as experienced in the development and implementation of quality systems to align with best practices and applicable regulations. She serves as an interim VP/Director of Clinical Operations with numerous clients; working with and mentoring their personnel as they start-up and execute complex studies. She routinely works with clients on inspection readiness activities including Mock BIMO audits, training on regulatory authority interaction during inspections, and inspection readiness preparation.
Lyn’s diverse therapeutic experience includes cardiology, neuromodulation, asthma/allergy, Duchenne muscular dystrophy, hereditary hemophilia and diabetes. Such a versatile background is sought by our early-stage and venture-backed companies to understand what is feasible in the clinic.
Prior to joining Halloran, Lyn was a Site Manager at Boston Scientific where she developed a remote monitoring group, implemented processes to govern the functions, and managed CRAs performing these activities. While at BSC, Lyn lead a cross-functional team of manager- and director-level staff to align clinical processes with corporate quality master plans. Prior to Boston Scientific, Lyn was a Clinical Affairs Manager at AAIPharma and oversaw the day-to-day activities of Research Associates and CRAs. She also held interim project management roles ensuring projects were executed on time and within budget. Before that, she was a Project Director at the Asthma Research Center at Brigham and Women’s Hospital.