My Career Objective
I am an experienced Clinical Research Scientist, Medical Writer and Regulatory/Medical Affairs Specialist with many years of experience in the bio-pharmaceutical and basic science research industries. I am seeking a position that will utilize the acquired and highly developed skills of outstanding communications, team-building, planning, supervisory, interpersonal and organization towards the successful discovery, development, approval and marketing of Biologics, Medical Devices and Pharmaceuticals.

My Executive Career Summary and Responsibilities

Following earning the Master of Science degree, I conducted basic science and preclinical research in academia and for the bio-pharmaceutical industry. I have planned and executed Phase I-IV domestic/international clinical trials in the bio-pharmaceutical industry for such indications as: Infectious Disease, Immunology, Inflammation, Pain, Osteoporosis, Ophthalmology, CNS, Vaccine, Gastroenterology, Medical Device and Oncology. I also have experience in Pharmacovigilance, Business Development, Outsourcing, Clinical and Sales Training, Market Research, Healthcare Compliance, Medical/Scientific/Regulatory Writing, Technology Assessment, Product/Portfolio Life Cycle Analysis, GCP/GMP Regulations, QA/QC Auditing, Product Life-Cycle and Supply-Chain Management, Clinical Registry, Domestic/International Regulatory Affairs. Marketing, Business Development, Outsourcing, PK/PD Studies, Safety Analysis, Clinical Outcomes Measurement, SAE Tracking, Project Management, Business Analysis, Investigator Identification/ Interactions, Data Management,, FDA Interactions, Budgets, NDAs, ANDAs. INDs, ISS/ISE Updates, Project/Program Plans, Patient Recruitment/Retention, Advisory Panels, SOPs, CRO Management, Project Team Management, Trial Master File Management and Pre-clinical, In Vivo Research.

My Clinical Project Management, Regulatory Affairs and Medical Writing Experiences

Confidential, East Hanover, NJ: Consultant Clinical Trial Manager
Translational Medicine Group; (3/2008-9/2008)
Significant Achievements:
Managed the assigned CRAs and clinical sub-team for a Multi-site, International Phase II PoC Clinical Study of Hepatitis B in Relapsed/refractive patients; Medical Writer; Revised/.Amended protocols and other regulatory documents ;Managed all Outsourcing activities; Indication/Disease: Infectious Disease/Hepatitis B

Confidential, Jersey City, NJ: Clinical and Pharmacovigilance Scientist,
Clinical Pharmacology (Phase I Unit); (9/2006-8/2007)
Significant Achievements:
Interfaced/Managed CRAs and other Project Team Members in Domestic Operations;
Managed all Outsourcing activities; Clinical Data Management (Oracle Clinical) Statistics/Biometry
Business Development/Market Research; Drug Safety /Pharmacovigilance; Regulatory/Medical Affairs (SOPs); Clinical Risk Management; GCP Compliance; Updated Outcomes Research Program Plans
Medical Writer: Developed protocol/ICs for three bioequivalence and pharmacokinetic (Phase I) studies

Confidential, NY, NY: Project Manager; (7/2005-8/2006)
Significant Achievements:
Performed project management for a successful multi-site, domestic pivotal Phase III Non-Hodgkin's Lymphoma patient-specific vaccine study. ; Managed all Outsourcing activities including CRAs
Performed operations lead Business Development and Market Research support; Monitor-oversight responsibilities; Medical Writer: Composed medical and regulatory documents; Indication/Disease: Oncology/Non-Hodgkin's Lymphoma

Confidential, Morristown, NJ: Consultant Senior Clinical Research and Regulatory Affairs Associate and Pharmacovigilance Scientist; (3/2005-6/2005)
Significant Achievements:
Performed site monitoring and data management for a multi-site oncology (HCC) Phase IIIb clinical trial
Documented Pharmacovigilance tracking and SAE reports; Indication/Disease: Oncology/Liver Carcinoma

Confidential, Nutley, NJ: Consultant Clinical Research Manager, (4/2003-2/2004)
Significant Achievements:
Managed an Investigator-Initiated Research Program in Oncology within Medical Affairs (Oncology) Group (Phase IV). ; Managed all Outsourcing activities; Conducted selected Market Research; Medical Writer; Composed protocols and other medical/regulatory documents Indications/Diseases; Oncology/ Breast, Liver, GI Cancers

Confidential, Lambertville, NJ: Clinical Project Manager; (10/2001-3/2003)
Significant Achievements:
Executed Clinical Project and Line Management of both in-house project support staff and field monitors for assigned projects;Managed the set-up and execution of a multi-site, Phase III infectious disease study in sinusitis;Developed and executed three, concurrent Phase IV Multi-site CNS studies in traumatic brain Injury;Conducted a Single-site (Investigator-Initiated) study of MS;Negotiated individual study site grants and contracts;Audited Automated Study Drug Supply and Procurement Operations ;Conducted outcomes research and Market Research studies, Business Development activities ;Master Study File management
Managed all assigned CRAs and other Outsourcing activities; Conducted Product Life-Cycle/ Supply Chain Management.; Medical Writer; Composed protocols and other medical/regulatory documents including ANDAs; Indications/Diseases; CNS/Dementia and Infectious Disease

Confidential, Skokie, IL and Bedminster, NJ: Consultant International Program Manager and Pharmacovigilance Scientist; (3/2001-9/2001)
Significant Achievements:
Assisted in the transition of the entire oncology program to new headquarters in New Jersey; Used MS Project management software to assist with resource management; Audited study-related activities of large SMO group; Audited activities of the IVRS, Central Laboratory, Tissue Bank and Central Pathology laboratory; Supervised CRF distribution; Managed GCP Compliance and the study management activities or the Ex-US study sites ;Conducted the overall study management and medical/regulatory affairs activities of a Phase III pre-cancerous, colon polyp prevention study (2000 patients, 120 sites in U.S., Canada, UK and Australia);Performed modifications in existing protocol and Informed Consent Statements along with refined reporting schemes for Serious Adverse Events from the three international Marketing Companies serving as country-specific CRO groups along with the ten (10) investigative sites in each country for the assigned CRAs in the UK, Canada and Australia; Managed all Outsourcing activities
Conducted Outcomes Research business analysis and market research activities; Audited Outsourcing of Drug Packaging and Regulatory Affairs of Labeling Activities; Prepared International Competitive Intelligence, Business Analysis and Pricing Strategy Reports; Oversaw GCP/GMP, Product Life-Cycle, Clinical Registry; Conducted Portfolio Analysis and Supply Chain Management.; Medical Writer; Composed clinical and regulatory documents; Indication/Disease: Oncology/Precancerous GI Polyps

Confidential, Flemington, NJ: Consultant Program Team Leader and Medical Writer, (1/2000-1/2001)
Significant Achievements:
Monitored a multi-site, Phase II oncology study in ovarian cancer; Initiated two, multi-site domestic Phase III studies in treatment of Head/Neck Cancer; Trained and managed in-house CRAs in field monitoring
Composed patient summaries/narratives from on-line database; Conducted Pharmacovigilance and SAE tracking; Responsible for Master Study File Management; Managed all Outsourcing activities
Conducted GCP/GMP, Product Life-Cycle, Business Development, Market Research and Supply Chain Management. Indications/Diseases: Oncology (Ovarian and Head/Neck Cancer)

Confidential, Princeton, NJ: Clinical Project Manager; (4/1999-1/2000)
Significant Achievements:
Initiated a Phase II domestic study in Asthma; Conducted project management activities for a Phase III, international study in osteoporosis; managed all Outsourcing activities; Trained and Managed CRAs
Managed SAE tracking; Responsible for Master Study File management; Conducted GMP/GCP, Product Life-Cycle, Business Development, Market Research and Supply Chain Management.; Medical Writer: Developed protocols and other clinical/regulatory documents; Indications/Diseases: Asthma and Osteoporosis

Confidential, Kenilworth, NJ: Assistant Project Leader and Sr. CRA (3/1997-3/1999)
Significant Achievements;
Initiated two multi-site, Phase III domestic clinical trials in the treatment of asthma (Adult and pediatric)
Managed the monitoring and data management activities of several in-house and field CRO monitors
Managed all Outsourcing activities; served as Manager and mentor of several in-house, contract CRAs
Conducted Pharmacovigilance, SAE tracking, Business Analysis, Market Research; conducted several QA/QC site audits; Medical Writer; composed protocols and other medical/regulatory documents: Indications/Diseases: Asthma and Allergy

Confidential, Waukegan, ILConsultant Medical Writer and Senior Regional Clinical Research Associate ;( 2/1995-2/1997)
Significant Achievements:
Contract Medical Writer for Lilly Labs, Indianapolis, IN, composed and edited final study reports as part of NDA in CNS area; Monitored 20 domestic and international study sites for a Phase III study in the treatment of asthma; Pharmacovigilance, Product Life-Cycle, Business Development and Supply Chain Management. ; Indications/Diseases: CNS (Schizophrenia) and Asthma

Confidential, Abbott Park, IL Senior Pharmacologist, Sr.CRA and International Program Manager; (5/1989-1/1995)
Significant Achievements
As Sr. Pharmacologist, developed and characterized in vivo assay for PAF receptor antagonist
As Sr. CRA setup and executed Phase I-III clinical trials (single and multi-site), domestic and International, in asthma, ulcerative colitis and rheumatoid arthritis.; Managed all CRAs and Outsourcing activities ;As International Program Manager participated in peri-approval activities for new class of asthma medication (e.g. Patient Cost Marketing Research, Sales Training in Asthma Therapy and presented clinical data at both domestic and international symposia; Medical Writer; Composed protocols, patient narratives for NDA and other regulatory documents; Indications/Diseases: Asthma, Ulcerative Colitis, Rheumatoid Arthritis and Allergy

Confidential, Radnor, PA and Monmouth Junction, NJ. Senior Scientist; (5/1983-4/1989)
Significant Achievements:
Development and characterization of new in vivo assays for acute and chronic inflammation and asthma
Conducted compound screening using in vivo model of asthma; conducted compound screening for combined 5-LO/CO inhibitor using in vivo models of acute and chronic inflammation
Developed animal model for acute inflammation caused PAF; Indications/Diseases: Acute and Chronic inflammation (allergy, arthritis and asthma)

My Education

Master of Science; Biology/Physiology/Endocrinology
Bachelor of Science (Liberal Arts; Biology/Chemistry Major)

My Most Significant Community Volunteer Leadership Roles

Eagle Scout (1964); Assistant Scoutmaster and District Commissioner (5 years);Active in community service clubs (Kiwanis, Jaycees and Lions; 10 years); Leadership roles in a corporate Toastmasters Club (6 years; CTM); Leadership roles as voluntary community advisor to local American Red Cross and Heart Association Chapters (10 years); Vice-Chairman of Board of Directors, Driver Training Chairman and EMT in local, volunteer Ambulance squad (6 years); Elected Member of Board of Trustees of my Homeowners Association (3 years); Pastoral Counselor, Lay Preacher and Sunday School Teacher in my church (Ongoing)