Clinical Research Physician with 22 years experience in Medical and Clinical Research Industry. Board Certified in General & Colorectal Surgery, completed a fellowship at Cleveland Clinic Florida, in Colorectal Surgery with special focus on Inflammatory Bowel Disease, Evacuation Disorders and Colorectal Cancer. Proficient in clinical development plan, clinical trial execution and management of all phases of drug
Clinical Research Physician with 22 years experience in Medical and Clinical Research Industry. Board Certified in General & Colorectal Surgery, completed a fellowship at Cleveland Clinic Florida, in Colorectal Surgery with special focus on Inflammatory Bowel Disease, Evacuation Disorders and Colorectal Cancer. Proficient in clinical development plan, clinical trial execution and management of all phases of drug development.
Experience includes (but not limited to):
•Plan, manage, analyze and control multiple aspects of clinical research project development
•Interaction with the FDA
•Creation of clinical study protocols
•Become a key “Medical Mind” interfacing with cross-functional teams within the Development Groups
•Managing CRO and other vendors
•Supervise participating clinical investigators to ensure studies are properly conducted
•Manage approved budgets
•Ensure adherence to standards of quality and compliance with GCP regulations
•Preparation of abstracts, manuscripts and presentations on Company’s products for scientific conferences
•Review and assess reports of adverse events (e.g., serious and unexpected); assess the causal relationship of the adverse events to the drug product(s); and review reports of safety data for submission to regulatory agencies.
Clinical research experience in multiple therapeutic areas including:
-General and Colorectal Surgery
-Neurology, Neuro-Psychiatry, Stroke/Stroke prevention
Drug Safety and Medical Monitoring of clinical trials
•Global Medical Leader in several Inflammatory Bowel Disease and Evacuation disorder studies.
•Therapeutic Area Leader for GASTROENTEROLOGY within CHILTERN and PAREXEL.
•Author of several publications and book chapters involving GI disorders, with special interest in surgical indications, constipation and outlet disorders.
Senior Director, Clinical Development @ • Lead a cross-functional clinical team for one or more compounds at various stages of development.
• Evaluate and provide clinical and technical input into drug development and discovery programs.
• Responsible for the strategy, direction, and design of clinical studies for the specific compound(s) under purview.
• Responsible for direct medical and scientific oversight of the development, conduct, and interpretation of assigned clinical study protocols. From August 2015 to Present (5 months) Senior Medical Director @ -Provide medical and scientific leadership for Covance Gastroenterology / General Medicine teams
-Provide oversight and guidance for Gastroenterology / General Medicine programs globally
-Responsible for medical monitoring of ongoing clinical trials
-Provide strategic consulting for Gastroenterology / General Medicine clinical trials
-Liaise with thought leaders in Gastroenterology
-Write clinical development plans and clinical trial reports
-Train project staff From November 2013 to July 2015 (1 year 9 months) Senior Medical Officer @ -Medical monitoring of Phase II-IV clinical trials
-Supported the Pharmacovigilance team to ensure that the patients’ safety was always maintained to the highest level
-Worked jointly with Business Development and Feasibility staff to assist with the acquisition of new clinical projects
-Provided support and advice to the Medical Affairs Department and other departments
-Became a ‘Overall Clinical Development knowledge resource’ for the department and Company From January 2012 to August 2013 (1 year 8 months) Raleigh-Durham, North Carolina AreaSr. Medical Director @ -Provided scientific and strategic guidance to clients and internal project groups with emphasis on medical issues
-Consultant regarding clinical drug development from pre-clinical through post-marketing
-Supported protocol development, regulatory submissions, and manuscript development
-Therapeutic area training
-Evaluation of new technologies
-Safety monitoring of Clinical Trials
-Co-chair of Expert Office Gastroenterology (part of Rheumatology/Immunology) From 2007 to December 2011 (4 years) Clinical Scientist @ -Managed scientific aspects of clinical trials and programs:
-Assisted in the creation of the Product Development Plan and Clinical Programs
-Identified and contracted expert consultants and thought leaders for projects as needed
-Organized, coordinated and executed Scientific Advisory Boards
-Medical monitoring of Clinical Trials
-Provided Medical Monitor support for safety evaluation
-Ensured protocol compliance for all trials and effectively communicate with high-profile sites and investigators
-Provided oversight for preparation of study reports and investigator brochures.
-Protocol design and finalization (including amendments)
-Assisted in the training on scientific aspects of clinical programs
-Assisted in the interpretation of clinical data and report writing
-Supported regulatory, scientific and clinical aspects of the: Investigators Brochure and updates, ISS and ISE from NDAs
-Interacted with Medical Affairs and Business/Marketing to ensure alignment of clinical programs with market objectives From 2005 to 2006 (1 year) Associate Director Oncology & CNS @ -Planned, managed, analyzed and controlled multiple aspects of clinical research project development
-Interacted with FDA regarding drug development / Safety
-Managed / hired contract research organizations and other vendors
-Supervised participating clinical investigators to ensure studies were properly conducted
-Created clinical study protocols and case report forms
-Prepared/coordinated clinical documents for submission to FDA (including briefing documents, study reports, and clinical sections for INDs and NDAs, as well as preparing responses to FDA's questions/suggestions)
-Managed approved budgets
-Served as primary liaison with global Project Leaders for specific product development
-Ensured adherence to standards of quality and compliance with Good Clinical Practice regulations and guidelines
-Prepared abstracts, manuscripts and presentations on IVAX products for scientific conferences on completed projects
-Supervised clinical research associates and administrative support personnel
-Reviewed and assessed the nature of reports of adverse events (e.g., serious and unexpected); assessed the causal relationship of the adverse events to the drug product(s); and prepared reports of safety data for submission to regulatory agencies. Assisted in the preparation and review of periodic safety reports
-Reviewed laboratory data for significant abnormalities and trends and contact investigational sites to collect additional data and assess significance of abnormalities, as needed in support of clinical trials
-Prepared and assured accuracy of full content of Annual reports From 2001 to 2005 (4 years) Clinical Research Colorectal Surgery - Gastroenterology @ -Managed multiple clinical trials as contracted by Pharmaceutical/Devices companies.
-Created clinical protocols where acting as Investigator in Investigator-initiated studies
-Wrote both prospective and retrospective studies for publication and presentation on behalf of the Department
-Managed the Anorectal Physiology Subdivision for the Department From 2001 to 2003 (2 years)
Board Certified General Surgeon, Doctor in Medicine @ Universidad de Buenos Aires From 1994 to 1999 Marcelo Piccirillo is skilled in: Oncology, Clinical Development, Clinical Research, Pharmacovigilance, Clinical Trials, Surgery, Gastroenterology, Pharmaceuticals, Diabetes, CRO, ICH-GCP, Drug Development, CTMS, Pharmaceutical Industry, Medicine
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