Director, Senior Clinical Research Consulting Resume

Desired Industry: Biotech	SpiderID: 28134
Desired Job Location: Niantic, Connecticut	Date Posted: 8/8/2009
Type of Position: Contractor	Availability Date: 09/10/2009
Desired Wage: Open
	U.S. Work Authorization: Yes
Job Level: Management (Manager, Director)	Willing to Travel: Yes, Less Than 25%
Highest Degree Attained: Doctoral	Willing to Relocate: Yes

Objective:
I would like to take the opportunity to introduce myself to you. I am a dedicated senior clinical research professional with the goal to continue the development of medical products that will prevent, enhance, and cure patients from harmful diseases.

Based on the philosophy of your company, it is with great interest that I am forwarding my resume for your consideration.

My record of academic achievements and professional career history, demonstrates attributes that make me a valuable employee. The attached document provides you with details of my skills and accomplishments, but I am certain that a personal interview would more fully reveal my desire and ability to contribute to your organization.

Thank you for your time and consideration, and do not hesitate to contact me at (732) 476-0857 or to my cell number (732) 762-9312 if you have any questions.

I look forward to speaking with you soon.

Experience:
PROFESSIONAL EXPERIENCE

PFIZER, INC., New London, CT. 2008 – 2009
Associate Director, Clinical Project Manager
• Oversaw the conduct of Phase 1 and 2 global clinical studies to ensure compliance with Federal, country, local regulations, company SOPs and guidelines within approved timelines and resources.
• Contributed successfully in the development of 3 study drugs and respective lifecycle: Phase 1 to Phase 2 under high degree of complexity.
• Developed overall project strategies; led cross–functional operational planning, conducted and completed multiple RA global clinical studies within programs alignment and resources while maintaining high degree of Quality Assurance.
• Oversaw and participated in study team operations and discussions covering all needs in the planning, execution, and closure of clinical studies.

PHARMACEUTICAL DEVELOPMENT SERVICES, LLC, Edison, NJ/Niantic, CT. 2007 – Present
Owner/ President
• Provide consulting – project management, clinical study management, monitoring – services that fulfill business needs for the biotechnology, pharmaceutical, medical device, medical equipment and CRO industries.

ADAMS RESPIRATORY THERAPEUTICS, INC., Chester, NJ. 2007
Consultant
• Planned, implemented, and completed successfully a seasonal clinical study Phase IV acute respiratory infection clinical study conducted under very challenging timelines. Led the senior CRO project team selected to conduct the study.

AEROTEK & SCHERING–PLOUGH, Kenilworth, NJ. 2006 – 2006
Consultant
• Coordinated and executed retrieval of regulatory packages and study data (Hepatitis C global Phase 4 clinical study) for global TMF from 20 plus countries that participated in a Hepatitis C global clinical study in a narrow timeframe.

JUAN REYES PAGE TWO

UNITEDHEALTH GROUP, Bridgewater, NJ. 2004 – 2006
Clinical Operations Manager, Sanofi–Aventis, Contractor
• Provided quality consulting services to oversee contracted CRO and vendors’ activities that led to successful planning, conduct and completion of outsourced clinical studies and IITs.
• Managed 10 plus anti–infectives Investigator Initiated Trials (IITs) for Key Opinion Leaders (KOLs) from synopsis to report. Liaised with KOLs, PIs and research staff to ensure proper study conduct, collection of study data and issuing of study report.

ORION PHARMA, INC., Florham Park, NJ. 2002 – 2004
Senior Clinical Research Associate
• Supervised, co–monitored, and supported the administration and progress of REVIVE I and II clinical study – a CHF Phase 3, multi–center double–blind study in Australia, Canada, Israel, and the US.
• Wrote, implemented, coordinated, managed and executed the Motivational Site Visit Plan that led to increase in the enrollment of Subjects for this clinical study.

QUINTILES, INC., Atlanta, GA. 2001 – 2002
Clinical Research Associate
• Monitored: Alzheimer’s disease and Schizophrenia, Phase IV, multi–center clinical studies, using EDC (MetaTrial™) in the Southeast.
• Ensured clinical sites complied with FDA regulations, ICH guidelines, company’s SOPs and protocol.

KENDLE INTERNATIONAL, INC., Cranford, NJ. 1998 – 1999
Clinical Research Associate
• Contributed (monitored: a Phase IV, multi–center clinical study in the U.S. & Canada for Westaim Biomedical Corp.) in the submission for marketing approval for Acticoat™ – a burn wound dressing.
• Contributed in the monitoring role in the evaluation of Celebrex® – a RA Phase III (GI Events): multi–center clinical study in the U.S. for Searle Corporation.

ETHICON, INC., Somerville, NJ. 1994 – 1998
Assistant Scientist
• Managed numerous non–clinical projects: developed models to evaluate and develop novel surgical devices (metallic, absorbable and micro suture anchors, H–device for meniscus repair and arthroscopy procedures), electrosurgical instruments, and surgical equipment during non–clinical phase.
• Wrote protocols and study results for non–clinical projects to test and develop models for PANALOK which led to (510K) submission/approval.

IMMUNOMEDICS, INC., Newark, NJ. 1992 – 1994
Laboratory Animal Tech, Immuno–Oncology
• Conducted ~ 200 state–of–the–art (radio–labeled monoclonal antibodies (Immuno–Oncology / Early Drug Discovery) assays – biodistribution, MTDs, and therapy – to detect and treat small tumors: colon cancer and lymphoma.
• Cultured and transplanted in–vitro and in–vivo lymphoma and colon cells: Daudi and LS–174T.

Education:
EDUCATION & CERTIFICATION

MS, Animal Sciences, Swine Nutrition, University of Missouri, Columbia, MO.
DVM, University Autonoma of Santo Domingo, Santo Domingo, DR.
Network Engineer, PCAge, Certified IT Career Institute, Edison, NJ.

Affiliations:
PROFESSIONAL ORGANIZATION MEMBERSHIP

Association of Clinical Research Professionals.

Skills:
Director / Senior Clinical Research Consultant with expertise in the development of global projects for the biotechnology, pharmaceutical, medical device, surgical / electrosurgical equipment, and CRO industries.

English & Spanish

• Team leader who drives the strategy, execution, and completion of global and domestic projects based on but not limited to historical data, risk mitigation, quality assurance, inspection readiness, and regulatory compliance.

• Successfully developed, conducted, and completed Inspection Readiness Plan for 20 plus global studies.

• Identified solutions to resolve subject enrollment issues during the conduct of global clinical studies leading to time reduction or completion within existing timelines.

• Planned and executed challenging clinical studies within projected timelines with exception of one study.

• Developed and managed rigorously study budgets from 10K to 16M to ensure completion of studies.

• Oversaw the planning and execution of four successful and well conducted face-to-face investigator meetings in Argentina, Czech Republic, and the US.

• Managed Sponsor and CRO project teams to implement and conduct an anti–infective upper respiratory clinical study Phase 4 Protocol designed to initiate 500 Sites and enroll 4000 Subjects.

• Reduced pre-clinical development of PANALOK from 1 ½ to 1 year in the planning, conduct, and completion the studies saving to the company a third in time, resources, and reduced 510K approval.

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