Joye Lynne Byrne **** Maryland Road Horsham, PA

*9090

301-***-**** acbqp9@r.postjobfree.com 914-***-****

OBJECTIVE Seeking position as Biomedical Project Manager, Clinical Scientist, Core Team Member, Senior

Clinical Research Associate, or Assay Development Professional

EDUCATION:

1997 B.S., Chemical & Biomedical Engineer, University of Kansas

2001 Clinical Research CE Curriculum, Society of Clinical Research Associates

EXPERIENCE:

2010- current Associate Clinical Scientist; Merck- Clinforce, North Wales, PA

• Drafted and reviewed Serious Adverse Event narratives for eight protocols, CSR, SUR, and NDA reports

• Supported protocol drafting including Core protocol, extended protocol (template based) and appendices for

five protocols across three MK compounds (ID/Vaccine)

• Completed QC for ten CSRs including results tabulation and conclusions summary

• Collated data tables in support of analysis, results, and conclusion summary for interim drug safety reports

• Supported delivery of Study Start-Up deliverables including Medical Monitoring Plan, Product Safety Risk

Language, CSMS study supply tables, and vendor supply checklists

• Prepared Investigator Meeting training presentation materials for pivotal 1572 protocols

• Verified Virological Response Data for PVG safety and study drug efficacy monitoring

• Resolved internally generated queries with international sites for three studies for final database lock

• Responded to team inquiries regarding integrated product safety reports and LSP protocols in SP Doors

2008- 2010 Process and Development Engineer Alternative Energy Resources; Bethlehem, PA

Technical Project Lead, Ph I Device Testing

• Identified partner equipment companies for hydrogen delivery and distribution technologies

• Built network of partners to support venture capital for hydrogen distribution and fueling stations

• Developed business model to supply additional capital through technology licensing to medium-

size plant licensees and business operations

• Traveled in Europe for 9 months as engineering representative to business development meetings and

technical forums in Scandinavia, Western and Eastern Europe, and Baltic

• Consultant to resolve technology limiting hydrogen delivery design problems for Ph I test vehicles

• Technical resource for identifying hydrogen generation and isolation processes in chemical refining and

electrical/bio-electrical engineering systems

• Managed the generation and translation of technical documents into ten international languages for product

technology description and specifications

• Resource for updates on latest high pressure/low temperature catalyst storage systems

2004- 2008 Sr. Clinical Research Associate, Core Team Support SCIREX-PRG Corp.; Horsham, PA

• Trained ten CRAs new to protocol through co-monitoring visits and peer phone contacts

• Performed QC of Site Investigator Files prior to Initial Drug Release for 2 study start-ups

• Coordinated sponsor approval and review of enrollment criteria for 12-15 active sites

• Supervised timely submission and review of SAE initial and follow-up reports to ensure accuracy

• Identified and recommended high-performing sites to business team for cross functional studies

• Achieved above expectations in meeting sponsor enrollment goals at 30 sites in long-term studies

• Completed Site Initiation and Close-Out Visits for five therapeutic areas

• Managed calibrations of ECG, centrifuge, spirometry, and gas flow equipment for 15 facilities

• Managed prohibitive medication lists for fellow CRAs for internal reference for 2 studies

• Consistently identified protocol deviations and ensured timely reporting to applicable IRB

• Ensured accurate review of CRF against source documentation to ensure GCP compliance through team

training, QC review, and site operations management

2001- 2004 Sr. Scientist, Clinical Research Associate National Institute of Health; Bethesda, MD

CRA for Phase I, II, IIIa Studies

• Designed and revised study protocols, SOPs, and CRFs compliant with FDA guidelines through collaboration

with operations and project management

• Isolated and resolved operational issues with contract diagnostic labs

• Developed training guides, source document templates, study initiation deliverables

• Coordinated monitoring activities to ensure frequency, quality, and compliance

• Managed reports of SAEs through collaboration with co-vigilance groups

• Coordinated oversight of patient database and queries for isolation and resolution of clinical data

• Supervised bio-statistical analysis for IND approval for anti-cancer agents

• Resolved CRF discrepancies through review, investigation, and closure

• Identified toxicological properties of candidate drug through laboratory investigation

• Cultivated Western Blotting protein isolation and PCR gene expression techniques to improve antibody

receptor signals

• Supported Lymphatic Oncology Pathway research through design of experiments, equipment

• sustaining, and laboratory technique troubleshooting

1997- 2001 R & D Engineer Intel Corp.; Santa Clara, CA

Technical Project Manager (Process/Equipment)

• Developed Reactive Ion Etch and Photolithography Systems

• Optimized Rf/microwave PLCs to eliminate circuit failures in product

• Installed/Validated $ 14 M of Plasma/ Radiofrequency capital Equipment

• Enabled product viability by optimizing Metal Patterning Optical Emissions

• Maintained product reliability by eliminating 0.5 micron Corrosion pathways

• Increased product yield through improvements to photo resist Weis process

• Designed kinetic systems to adjust electrical dimensions to blueprint targets

• Volumized Implant manufacturing by eliminating Overcurrent Heat Transfer

• Refined and piloted photo resist scale-ups to increase product line capacity

1995-1996 Project Engineer COOP Olin Chemical Corp.; Lake City, MO

• Maximized output by supervising Dispersing Agent Slurry Optimization Project

• Conserved inventory viability by coordinating Grounding Design Project

• Isolated contaminants through Lead Styphnate Crystallization Project

• Designed test assembly equipment to reduce Stat. Process Control expenses

• Resolved daily manufacturing limiters such as inherent equipment/process errors

• Supervised buyers and suppliers to procure and expedite mfg chemicals

• Managed transport of hazardous materials in compliance with DOT guidelines

1991-1994 Medical Tech Aid Newman Memorial Hospital; Emporia, KS

• Troubleshoot hard downs for ELISA, HemaCoulter, and small digital equipment

• Controls analysis for HemaCoulter & UA equipment, Cross-Match, and BT lab

• Bacteriology lab- Agar Smears, Blood Culture prep, pH flora spectrum analysis

• PKU, Blood Culture, and Chem Assay collections; HemaCoulter operations

CLINICAL TRIAL EXPERIENCE:

Gastro-Oncology: A Phase II Randomized Controlled Study Comparing the Survival of Patients With

Unresectable Hepatocellular Carcinoma (HCC) Treated With THYMITAQ To Patients Treated With

Doxorubicin

Oncology/Cardiovascular: Phase II Study of FR901228 (Depsipeptide) in Patients with Cutaneous T-Cell

Lymphoma, Relapsed Peripheral T-Cell Lymphoma, or Other Mature T-Cell Lymphoma

Oncology: Phase II Study of Trastuzumab (Herceptin) and Paclitaxel in Patients with HER2-

Overexpressing Metastatic Breast Cancer

Oncology: A Randomized Multicenter Trial of Involved Field Radiotherapy Versus Involved Field

Radiotherapy Plus Chemotherapy in Combination With Rituximab (Mabthera®) for Stage I - II Low

Grade Follicular Lymphoma

Cardiovascular: An Efficacy and Safety Study of Reslizumab (CTX55700) in the Treatment of Poorly

Controlled Asthma in Subjects with Eosinophilic Airway Inflammation

Infectious Disease/Dermatology: Nuvocid™ (oritavancin) at Single or Infrequent Doses for the Treatment of

Complicated Skin and Skin Structure Infections (SIMPLIFI)

Infectious Disease: Safety, Antiviral and PK activity of Vaniprevir, a Hepatitis C Virus NS3/4A Protease

Inhibitor, in Patients with HCV Genotype 1 Infection

Infectious Disease: A Phase 2b, Safety and Efficacy Study of Boceprevir in Patients Coinfected with HIV

and Hepatitis C (Protocol No. P05411)

Infectious Disease: Boceprevir and Peginterferon/Ribavirin for the Treatment of Chronic Hepatitis C in

Treatment-Naive Subjects: A Comparison of Erythropoietin UseVersus Ribavirin Dose Reduction for the

Management of Anemia (Protocol No. P06086)

Infectious Disease: A Phase II Open Label Study of MK 7009 Administered Concomitantly with

Pegulated Interferon Alfa 2a and Ribavirin to Patient with Chronic Hepatitis C Infection After

Participation in Other MK 7009 Clinical Trials

Infectious Disease: Pharmacokinetics and Safety of Oral Posaconazole in Subjects at High Risk for

Invasive Fungal Infections (Phase 1b, P05615)

Infectious Disease: Multi-Center Double-Blind Randomized Dose Ranging Study to Compare the Safety

and Activity of MK 0518 Plus Tenofovir and Lamivudine 3TC Versus Efavirenz Plus Tenofovir and

Lamivudine 3TC in ART Naïve HIV Infected Patients

Infectious Disease: Multi-Centered Double Blind Randomized Dose Ranging Study to Compare the

Safety and Activity of L-000900612 Plus Tenofovir and Lamivudine Versus Efavirenz Plus Tenofovir and

Lamivudine 3TC in ART Naïve HIV Infected Patients

Infectious Disease: Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety

and Activity of MK 0518 Plus Tenofovir and Lamivudine 3TC Versus Efavirenz Plus Tenofovir and

Lamivudine 3TC in ART Naïve, HIV Infected Patients

Infectious Disease: Multicenter, Double-Blind, Randomized, Dose Ranging Study to Compare the Safety

and Activity of MK 0518 Plus Tenofovir and Lamivudine 3TC Versus Efavirenz Plus Tenofovir and

Lamivudine 3TC in AR-Naïve, HIV Infected Patients.

Gastroenterology: A Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Low-Dose

Naltrexone HCL (PTI-901) in Female Patients with Irritable Bowel Syndrome

Gastroenterology: A Multicenter, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Low-

Dose Naltrexone HCL (PTI-901) in Male Patients with Irritable Bowel Syndrome

Orthopedic: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Efficacy and

Safety Study of PTI-821 in Patients with Moderate to Severe Chronic Pain Due to Osteoarthritis of the

Hip or Knee

Orthopedic: A Multicenter, Randomized, Double-Blind, Active- and Placebo-Controlled, Phase III,

Efficacy and Safety Study of Oxycodone HCl and Low-Dose Naltrexone HCL (PTI-801) in Patients with

Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee.

References Available upon request

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