Laurel De George, Pmp Email & Phone Number

New York, NY, US

Cambridge, Massachusetts, United States

Cambridge, Massachusetts, United States (WFH)

Multidisciplinary integration between the CNS group and clinical and regulatory functions. Direct clinical program development, including both single and multi-site trial design and operations. Serve as CNS group’s principal liaison to Sana’s clinical and regulatory groups. Accountable for development and direction of patient engagement and recruitment.

New York City Metropolitan Area

Lead team of 19, including neurosurgeons, neurologist, biomedical engineer, statistician, radiologist, psychiatrist, coordinators, trainees and numerous ancillary personnel at 5 sites in federally funded feasibility clinical trial studying use of deep brain stimulation (DBS) for traumatic brain injury (TBI) (CENTURY-S, NCT#02881151). Primary correspondent.

New York, NY

Project manage clinical trials, including handling FDA submission for study of deep brain stimulation for traumatic brain injury on behalf of this major biomedical research unit and academic medical center of Cornell University.➤Organized last minute pre-submission IDE application and meeting, including identifying FDA device consultant to assist with.

WFH

Developed clinical trial budgets, timelines and regulatory submissions to form stem cell-based therapeutics biotechnology company for 3 neurologic indications (1 rare adult disease, 1 rare pediatric disease, 1 late-stage adult disease). Wrote clinical sections of regulatory filings and delivered general trial design with special focus on adherence, patient.

WFH

Planned international consortium application for stem cell-based treatment of white matter disease. Developed patient engagement program for project using qualitative research methods.

New York, NY

Managed and coordinated all activities on behalf of scientific leader of a 600-patient, 67-site NIH-funded Phase III clinical trial that analyzed effects of Coenzyme Q10 (CoQ10) on newly diagnosed Parkinson’s patients (QE3). Contributed to IND submissions and FDAAA results reporting at study’s conclusion. ➤Monitored drug production and worked with.

Managed planning of $15M multi-investigator, multi-disciplinary grant proposal to New York State Stem Cell Board (NYSTEM) for assessing stem cell-based strategy in treatment of Parkinson’s disease

Master Of Arts (M.A.), Anthropology

Bachelor Of Arts (B.A.), Sociology And Anthropology

Pmp Certification, Project Management