Director of Clinical Operations/PM Resume
|Desired Industry: Biotech
|Desired Job Location: Taunton, Massachusetts
||Date Posted: 3/12/2008
|Type of Position: Full-Time Permanent
||Availability Date: March 24, 2008
|Desired Wage: 175,000
||U.S. Work Authorization: Yes
|Job Level: Management (Manager, Director)
||Willing to Travel: Yes, Less Than 25%
|Highest Degree Attained: Masters
||Willing to Relocate: Yes
Senior clinical research executive with vast experience and a multi-therapeutic acumen in global clinical study management looking for a FT research challenge. A breadth of experience in start-up firms, venture capital funded, private and public firms encompassing all phases and types of medical product research. A focused passion in leadership, operations and development skills with a proven ability to manage high performance teams. Business savvy with extensive hands-on process improvement and project management abilities. A strategic thinker able to develop cross-functional efficiencies and cost effective solutions to business challenges. Highly regarded by managers and peers for creative and innovative solutions to complex issues with a focus on achieving results.
THE WILMARK GROUP, Wellesley, MA 2005 ¡V 5/2007
Private executive/ professional temporary staffing firm.
SERACARE LIFE SCIENCES, Cambridge, MA (client)
Public (SRLS.PK) midsize Biopharmaceutical and Diagnostics company.
(Division, Genomics Collaborative acquired by BioServe Biotechnologies Ltd.)
Director of Clinical Operations
„P Managed and directed all aspects of the clinical programs globally and facility operations in Cambridge.
„P Re-structured operational practices of a re-organized team to stabilize and deliver client data on time.
„P Responsible for overall direction of department operations, strategic plans, vendor selection, parent company initiatives, SOP development and training.
„P Advised senior executives on operational implications and due diligence efforts to achieve a successful acquisition.
„P Managed day to day operations of project management, data management and laboratory testing support services. Manage outsourced vendors and consultant staff. Collaborated with the sales team on client proposals and feasibility of clinical research.
ACUSPHERE, INC., Watertown, MA (client)
Small specialty pharmaceutical company partnered with Nycomed Danmark APS
(Also included independent work performed June 2007 for Sr. VP of Operations)
Interim Director of Clinical Operations
„P Responsible for clinical department budget, contracts, and CRO/vendor business.
„P Supported overall interdepartmental needs and business partner goals by coordinating a shared resource pool approach for contract team members within clinical research.
„P Created ICH-GCP compliance program and developed a corporate-wide outsourcing program to reduce costs and minimize regulatory risk.
„P Responsible for departmental SOP revisions.
„P Provided direction on the business aspects of all clinical research strategies.
OXXON THERAPEUTICS, INC., Boston, MA (now Oxford Biomedica) 2004 ¡V 2005
Small start-up, venture capital funded biotechnology company.
Sr. Clinical Project Manager
„P Managed all global aspects of HIV clinical development program.
„P Responsible for CRO selection and coordinating activities of in-house (US/UK) and contract staff, in order to meet company objectives.
„P Developed protocol/ICF and advised on the IB to reduce regulatory agency activities.
„P Implemented an EDC/IVRS system for the HIV Immunotherapeutic product to reduce costs by 30%.
„P Negotiated budgets/contracts for all project vendors and tracked scope and milestone progress.
„P Served as US liaison for pre-clinical toxicology activities and wrote pharmacovigilance SOPs.
„P Responsible for global assessment and creation of development plans/strategy in order to align SOPs and develop operational best practices.
AAI PHARMA, Natick, MA 2003 ¡V 2004
Publicly traded, mid-size CRO/development company
„P Accountable for all aspects of assigned clinical projects (clients included Roche, Shire, Sanofi-Aventis and Sepracor).
„P Supervised a multidisciplinary project team to ensure the accurate and timely completion of all contracted scope of activities.
„P On-going management of contracts, budget, database, trial master files, and all project plans/charters/guidelines.
„P Managed project-specific training for all team members to reduce error rate and increase performance.
„P Wrote and oversaw finalization of PM/Communication/SAE/risk/Statistical analysis plans.
„P Worked closely with the Business Development team on new business proposals/bid defense presentations for client contracts in excess of 10million.
„P Participated in the SOP/best practices steering committee to modernize procedures.
ANTIGENICS INC., Lexington, MA Jan ¡V Aug 2003
Small public biotechnology company(AGEN)
Sr. Clinical Project Manager
„P Managed all aspects of an international Phase III (US, UK, Australia, Germany, Poland, Italy, Russia/Ukraine) (80 sites) and a Phase II melanoma trial.
„P Centralized all global CRO and contractor activities to increase performance and central management in order to reduce time to open sites. Opened 30 sites in Russia/Ukraine in two months.
„P Negotiated KOL, CRO contracts and site budgets in excess of 8million.
„P Oversaw coordination of SAE management and regulatory packages in all countries.
„P Implemented new project tracking to achieve monthly project milestones and development goals.
„P Standardized global monitoring and operational plans so that clinical development SOPs could be re-written with a global strategy.
NEOTERIX, LLC, Clearwater, FL 1999 ¡V 2002
Privately held consulting firm for FL High Tech corridor.
„P Provided contract clinical research services to sponsors, site management organizations, contract research organizations, IRBs, and physician practices.
„P Provided the following services: Clinical Trial Design, Clinical Project Management, Regulatory and Safety Development and Compliance, Marketing and Advertising, Recruitment, Web Site Design, SOP development and Hazmat Training.
APHERESIS TECHNOLOGIES, INC. /OCCULOGIX, INC.; Palm Harbor, FL 1999 ¡V 2001
Small Medical Device distributor partnered with Occulogix/Asahi Medical.
„P Managed all aspects of a multi-site (18 US) clinical trial including in-house staff (15) and CROs.
„P Responsible for all regulatory submissions and correspondence with all sites, IRBs and FDA.
„P Managed protocol and consent development.
„P Responsible for site selection, auditing, and training.
„P Implemented operational changes to reduce time to complete enrollment and improve site compliance/performance.
„P Coordinated literature strategy, public relations campaigns and all marketing/branding of the AMD-02-99 trial which led to an increase in enrollment for all geographies.
UNIVERSITY OF SOUTH FLORIDA, OFFICE OF RESEARCH; Tampa, FL 1997 ¡V 1999
Clinical Research Coordinator
„P Served as lead CRC in 27 various HIV, STD, diabetes and hypercholesterolemia trials in four institutions.
„P Accrued top 1% of subjects enrolled for Lipitor„¥ trial and top 10% for all other trials.
„P Created source documentation and maintained CRF's (EDC and safety reporting included), regulatory binders, drug accountability, safety reporting and IRB compliance.
„P Reviewed and negotiated all new potential sponsor protocols/contracts.
„P Designed and managed recruitment plans and coordinated placement with media buyer.
UNIVERSITY OF SOUTH FLORIDA
Master of Public Health, Epidemiology, 1996
Curriculum specialties: Cancer and Infectious Disease Epidemiology,
Clinical Trials Phases I-IV
Thesis project on bone marrow transplantation as it relates to specific oncogenic treatments and environmental issues comparing infectious complications.
Served as co-investigator and worked with H. Lee Moffitt Cancer Research Institute, Tampa, FL. Design: Six month retrospective study, including db mining analyses.
UNIVERSITY OF SOUTH FLORIDA
Bachelor of Science, Microbiology, 1988
UNIVERSITY OF PITTSBURGH
Medical Technology, 1984-1985: 29 credits
Massachusetts Biotechnology Counsel, PM Committee, Member 2004 ¡V 2006
Project Management Institute, Member 2003 ¡V 2006
Suncoast Chapter of ACRP - founding board member 1998 ¡V 2002
Association of Clinical Research Professionals, Member 1996 ¡V 2002
American Public Health Association, Member 1996 ¡V 1998
-Complex Global Management
-Senior Management Advisor
-Long Range Business Planning
-Strategic Initiative Implementation
-Operational Excellence Initiatives/Organization Change Management
-Strategic Research Design
-Pre-clinical thru Phase IV
-Global Regulatory Compliance
APPENDIX OF CLINICAL TRIALS
Genomics Collaborative/SeraCare 99-501/99-502/C-103 Anonymized Collection of Subject Biological Specimens and Phenotypic Data for Inclusion in a Repository and use in Genomic, Serologic, Metabolic and Proteomic Research Studies (Global) (includes over 20+ sub-studies)
Acusphere AI-700-32 A Phase 3, International, Multicenter, Open-Label, Dual-Injection, Echocardiographic Imaging and Safety Study of AI-700 in Patients with Suspected Ischemic Heart Disease Undergoing Single-Photon Emission Computed Tomography. (Global)
Acusphere AI-700-33 A Phase 3, International, Multicenter, Open-Label, Dual-Injection, Echocardiographic Imaging and Safety Study of AI-700 in Patients with Suspected Ischemic Heart Disease Undergoing Diagnostic Coronary Angiography. (Global)
Oxxon Therapeutics (VIP study) A randomized, placebo controlled, phase I/II safety, immunogenicity, and exploratory efficacy evaluation of heterologous PrimeBoost immunotherapy incorporating MVA.gpn prime followed by FP9.gpn boost, in HIV-1 infected subjects currently receiving Highly Active Antiretroviral Therapy (HAART). (Global)
IND #BB7823 Roche Laboratories Inc. An open label, multicenter, randomized safety and tolerability pilot study of Pegasys (Peginterferon alfa-2a) plus COPEGUS (Ribavirin) in previous intravenous drug users (IVDUs) who are currently enrolled in a methadone maintenance treatment program. (US)
Sepracor Pharmacoeconomic Outcomes of Levalbuterol and Racemic Albuterol in In-Patients Requiring Nebulization (POLARIS). (US)
Shire Laboratories Inc. LAM-IV-307 A Multicenter Phase III Comparison of Renegal with Lanthanum Carbonate in End Stage Renal Disease. (Global)
IND #6929 Antigenics Inc. C-100-21 A Phase III Study of Heat Shock Protein-Peptide Complex (HSPPC-96) versus Physicians Choice Including Interleukin-2 and/or Dacarbazine/Temozolomide-based Therapy and/or Complete Tumor Resection in Stage IV Melanoma. (Global)
IND #6929 Antigenics Inc. C-100-22 Vaccination With Tumor Derived, Autologous Heat Shock Protein Peptide Complex-96 (HSPPC-96) With GM-CSF and IFN In Patients With Stage IV Resectable Malignant Melanoma. (Global)
IDE #G970241 Apheresis Technologies, Inc. AMD-02-99 A Multicenter, Prospective, Randomized, Double-Masked, Study Comparing the Safety and Efficacy of Membrane Differential Filtration to a Placebo Treatment in Patients With Non-Exudative Age-Related Macular Degeneration. VOL AMD-02-99 and pilot study Protocols all under IDE #. (US)
20 + other studies coordinated
Available upon request.
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