Leslie Lilly Email & Phone Number

Concord, Ma

As an experienced clinical researcher I can help your organization by providing the following services:• Organize and lead multidisciplinary product development teams to draft clinical program development strategy• Operationalize clinical program development strategy into a day to day plan of activities with associated milestones• Work with your team to determine clinical protocol design and draft subsequent protocol • Organize and lead protocol design meetings with key opinion leaders/clinical investigators• Prepare necessary clinical documentation for regulatory and IRB/EC submissions • Identify, and interact with, prospective investigators and academic thought-leaders• Perform Contract Research Organization, Central lab or other 3rd party vendor evaluation, selection, liaison, and management• Trial oversight • Data analysis, interpretation, and presentation• Write clinical study reports, abstracts, and manuscripts• Provide clinical insight in regulatory authority meetings and related interactions

Marlborough, Ma

Novel body worn insulin delivery device company.Created clinical research department and supporting infrastructure.Planned, designed, executed, analyzed data from normal volunteer, human factor, and clinical research studies to support iterative device development, approval, reimbursement, and market adoption. Presented at scientific meetingsPublished data in peer reviewed journals

Concord, Ma

Provided clinical research expertise to biotechnology start-ups (build clinical research department infrastructure, initiate clinical programs), medical device companies (PMA submission and FDA advisory panel), biotechnology industry conference company (developed strategy for new line of scientific and clinical conference tracks).

Cambridge, Ma

Instrumental in re-organization of Clinical Research & Development into two departments: Medical Research and Clinical Operations. Reorganization resulted in better work flows and more efficient timelines for reaching key milestones for clinical development programs. Directed staff charged with managing multidisciplinary teams who planned and implemented world-wide hemophilia recombinant replacement factors 8 and 9, phase I-III kinase inhibitor, conjugated antibody, and chemotherapy Oncology clinical trials.Liaison with compliance department to ensure FDA and EMEA inspection readiness.

Cambridge, Ma

Directed strategic planning, execution, and analysis of data for novel combination device/biologic clinical program (rhBMP-2) in craniofacial bone regeneration. Managed preparation of IDE, clinical protocols, clinical study reports, and annual IDE and periodic safety update reports (PSURs). Hired, trained, and managed staff to support these activities. Supervised CROs and outside vendors providing services for the clinical program

Cambridge, Ma

Led the initiation and conduct of clinical development program for a topical enzymatic debriding agent in burn patients, including preparation of IND application, clinical protocol, and clinical study report. Supervised the training of Clinical Research Associates.

Cambridge, Ma

Project LeaderLed company’s first proprietary project during crucial re-evaluation phase (recombinant macrophage colony stimulating factor). Redefined project goals, strategy, and timeline.Senior Clinical ScientistDeveloped infrastructure of a newly forming clinical research department and drafted phase I/II Oncology clinical protocols to evaluate murine monoclonal antibodies and recombinant macrophage colony stimulating factor (rhMCSF).• Led evaluation and selection of CRO, central labs, and other outside vendors.• Organized and executed off-site investigator meetings.• Authored and reviewed clinical IND safety reports, investigator brochure, and annual reports to the FDA. Collaborated on filing of IND for recombinant colony stimulating factor and investigator/NCI sponsored INDs.

Palo Alto, Ca

• Drafted protocol (and all associated documents), initiated, trained and monitored investigative sites and managed 250 patient phase II ace-inhibitor dosing study at 20 investigative site across the US and Canada. • Successfully recruited investigators for multicenter phase II trial. Negotiated budgets and contracts, coordinated labeling and shipment of study drug.

Stanford, Ca

• Surgical orthopedics.• Coronary critical care – Took care of patients with lethal arrhythmias, acute MIs, and cardiomyopathy awaiting heart transplants. During this time, was involved with device (automatic internal defibrillators) and drug trials (amiodarone and diltiazem).