robert laliberte

director, immuno-oncology clinical scientist

About

Over 20 years of clinical research experience in Phase I through Phase III clinical trials, primarily in oncology but also in infectious disease vaccine and hemophilia therapeutic areas. Hands-on clinical operations and clinical science professional experienced in preparing clinical trial and departmental budgets, resource projections, development of standard operating procedures, supervision of in-house personnel and external vendors, investigative site monitoring visits, review of patient data listings, preparation of scientific abstracts and posters, etc. Extensive writing experience including numerous clinical study protocols, investigator brochures, model informed consent forms, laboratory manuals, clinical study reports, clinical sections of regulatory submissions, etc.

Country

united states

City

boston

Industry

pharmaceuticals

Skill

drug development, oncology, clinical trials, clinical development, clinical operations, biotechnology, pharmaceutical industry, life sciences, regulatory submissions, sop, fda, cro, protocol, medical writing, clinical research associates, infectious diseases, gcp, lifesciences, biopharmaceuticals, vaccines, edc, clinical science, data review, team leadership, clinical site monitoring, line maintenance, coaching, budgets, tumor immunology, clinical research, cross functional team leadership, orphan drugs, rare diseases, crf design, data analysis, sae reconciliation, kol, communication, presentation skills, scientific writing

Experience

lead clinical research associate

centocor

1994-1 - 1998-1 · 4 yrs 1 mo

Study management and monitoring for assigned products (in vitro diagnostics: oncology, HIV and cardiovascular). Prepared clinical development plan, budgets and protocols.

clinical sceintist and associate pharmacologist

dupont pharmaceuticals

1988-1 - 1994-1 · 6 yrs 1 mo

Study management and monitoring of Phase 1-3 cancer chemotherapy trials covering most tumor types. Medical writing including clinical study reports, IB updates, IND annual reports, and study protocols.

executive director, clinical research

ziopharm oncology

2011-1 - 2011-11 · 11 mos

Provided Clinical Science support for oncology drug development programs, including medical writing, protocol development, and data review.

senior director, clinical operations and clinical science

celldex therapeutics

2007-6 - 2011-1 · 3 yrs 8 mos

Managed Clinical Operations & Science for Avant Immunotherapeutics and subsequently focused on Clinical Operations after merger with Celldex (March 2008).

director, clinical operations

ariad pharmaceuticals, inc.

2004-5 - 2007-6 · 3 yrs 2 mos

Position encompassed Clinical Operations and Clinical Science functional areas.

vp, clinical operations and clinical science

galena biopharma, inc.

2014-1 - 2015-3 · 1 yr 3 mos

Clinical Research Lead and cross-functional Product Development Team Leader for Anagrelide CR (GALE-401). Established Clinical Operations infrastructure and conducted Phase 2 trial in a partially outsourced model.

director, drug development

curis

2011-11 - 2014-1 · 2 yrs 3 mos

Managed Clinical Research, Drug Safety and Regulatory functional areas.

associate director, clinical research

pfizer

1998-1 - 2004-1 · 6 yrs 1 mo

Associate Director, Hematology - Clinical Project Team Leader for ReFacto AF (recombinant factor VIII). Provided Clinical Operations and Clinical Science leadership concluding in a U.S. BLA submitted within 30 days of last patient visit. Assistant Director, Oncology - Supervisory position with responsibility for CTMs, CRAs and Administrative Assistants. Clinical Science data review and writing (e.g., protocols, study documents, reports, Clinical Development Plan, IB updates). Sr. Clinical Research Associate, Oncology - Study management and monitoring for assigned Phase 1 and Phase 2 studies.

director, immuno-oncology clinical scientist

pfizer

2015-7 - 2016-12 · 1 yr 6 mos

Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place, as well as some of the world's best-known consumer healthcare brands. Every day, our colleagues work in developed and emerging markets to treat, cure and eradicate life-threatening conditions and challenge some of the most feared diseases of our time. Pfizer also collaborates with healthcare providers, governments and local communities to support and expand access to reliable, affordable healthcare around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more, visit www.pfizer.com.