Laurel De George, Pmp Email & Phone Number

New York, Ny, Us

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 efforts specific to each of the CNS group’s disease targets. Develop relationships with appropriate patient advocacy groups. Supervise CNS Program Manager.➤ Serve as regulatory lead on pre-IND meeting package. Identify and manage external regulatory consultants to supplement internal resources. Refine regulatory and clinical strategy. Develop and maintain timeline. ➤Vet and select vendor to co-create protocol with patient and clinical site input. Discern needs to build foundational understanding of patient journey. Develop timeline and manage vendor relations.

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 for FDA submissions to Center for Device and Radiologic Health (CDRH). Develop and execute successful patient recruitment campaign. Oversee internal operating budget.➤CENTURY-S Clinical Trial: Manage CENTURY-S clinical trial in collaboration with investigators and research team. Partner with internal resources, regulatory consultant, funding agency, and device manufacturer to manage preparation of IDE and submit on time. ➤ Clinical Trial Recruitment: Organized patient recruitment and sourced/hired marketing firm. First 16 months of recruitment yielded 34 inquiries and no randomizations; new digital media campaign generated 400+ inquiries with multiple randomizations - meeting NIH recruitment milestones. Developed hybrid print and digital campaign to identify participants with no/limited access to internet. Digital media campaign yielded 100% of all implanted participants.

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 regulatory submission and collection of information from device manufacturer. ➤Prepared IDE sponsor for FDA meeting in collaboration with consultant. Debriefed and followed up with FDA on pre-submission application.➤Coordinated communication and managed project to introduce cloud-based app for remote patient monitoring.

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 engagement, and suicide prevention. Developed integrated program timeline with team for executive board review. Developed relationships with patient advocacy groups. Funded by Novo Seeds, Copenhagen, Denmark.

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 distributor to ensure adequate drug supply for 67 clinical sites. ➤Liaised between Cornell team and the clinical trials coordination unit at University of Rochester in connection with this international trial. Coordinated efforts to maintain regulatory compliance with both FDA and Health Canada.➤Managed lab workflow for pharmacokinetic (PK) testing for 2 additional clinical trials that studied CoQ10 in movement disorders. Ensured data transfer to statisticians for each study was on time for analysis, and dissemination prior to Data Safety Monitoring Board (DSMB) meetings. ➤Added value as project manager, including securing funds to develop database to track progress of contract and amendment negotiation for QE3, the largest clinical trial Cornell ever sponsored at the time.

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