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Senior Clinical Leader with extensive experience in clinical research, clinical operations, good clinical practice (GCP), usability engineering, and strategic planning in pharmaceutical, biotechnology, and medical device industries. Demonstrated record of building infrastructure, clinical programs, alliances, multidisciplinary teams, and investigative site networks to execute novel clinical development programs that have generated data for market approval, PMA and CE mark, and market adoption. Committed to bringing novel therapeutic products to the marketplace that will advance medicine to either cure, or make living with, a disease easier for the person who has it. Therapeutic experience includes: orthopedics, cardiology, oncology, wound healing, tissue (bone) regeneration, hemophilia, and type 2 diabetes.
Lilly Clinical Research Consulting Services
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Senior ConsultantLilly Clinical Research Consulting Services Feb 2017 - PresentConcord, MaAs 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
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Head Of Clinical ResearchCequr May 2009 - Dec 2016Marlborough, MaNovel 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 -
ConsultantClinical Research Consulting Services Aug 2006 - May 2009Concord, MaProvided 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).
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Senior Director, Clinical OperationsWyeth Jan 2004 - Jul 2006Cambridge, MaInstrumental 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.
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Director Cr & DWyeth Nov 1993 - Dec 2003Cambridge, MaDirected 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
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Manager Clinical AffairsGenzyme Feb 1992 - Nov 1993Cambridge, MaLed 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. -
Project Manager/Senior Clinical ScientistGenetics Institute Jun 1989 - Jan 1992Cambridge, MaProject 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.
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Clinical Research AssociateSyntex Research Dec 1986 - Jun 1989Palo 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. -
Staff NurseStanford University Sep 1982 - Dec 1986Stanford, 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).
Leslie Lilly Skills
Leslie Lilly Education Details
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Nursing
Frequently Asked Questions about Leslie Lilly
What company does Leslie Lilly work for?
Leslie Lilly works for Lilly Clinical Research Consulting Services
What is Leslie Lilly's role at the current company?
Leslie Lilly's current role is Clinical leader (pharma/biotech/med device) who helps you draft clinical strategy, build teams & investigator networks..
What is Leslie Lilly's email address?
Leslie Lilly's email address is le****@****ast.net
What is Leslie Lilly's direct phone number?
Leslie Lilly's direct phone number is +161777*****
What schools did Leslie Lilly attend?
Leslie Lilly attended San Jose State University.
What skills is Leslie Lilly known for?
Leslie Lilly has skills like Cross Functional Team Leadership, Program Management, Clinical Development, Clinical Trials, Oncology, Biotechnology, Regulatory Submissions, Clinical Trial Management, Gcp, Medical Devices, Endocrinology, Hematology.
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Leslie Aguilar
Nashville, Tn1tractorsupply.com
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