• Provided project direction, leadership for the preclinical toxicology assessment, manufacture and clinical development of biopharmaceutical products.
  
• Identified product development strategies, risk and provided options to limit risk.
  
• Identified critical tasks and resources.
  
• Ensured that the project timeline was met and the quality of work maintained in a cost effective manner.
  
• Prepared and negotiated contracts with contractors resulting in substantial cost savings to the Sponsor.
  
• Prepared budget proposals, organized resources and tracked resource usage, prepared and maintained Gantt charts.
  
• Organized and led project team meetings.
  
• Managed and developed an excellent working relationship with contractors (CROs, CMOs, Contract Laboratories, Data management contractors) with considerable positive feedback

• Assessed biopharmaceutical products and platform technologies including:
  
  • Assessment of preclinical data, CMC data, clinical trial design and study protocols.
    
  • Literature review of scientific and clinical information.
  • Review of grant applications.
    
• Assisted in the identification and preparation of an appropriate regulatory strategy, product development plan and clinical development plan (CDP).
  
• Contributed to design of preclinical pharmacodynamic and toxicology studies.
  
• Authored FDA pre-IND meeting and IND submissions, which included:
  
  • Preclinical pharmacology and toxicology section.
    
  • Clinical section; CDP, study protocols, Investigator's Brochure.
    
  • CMC information; GMP manufacture.
    
  • Prepared FDA meeting request letters.
    
  • Correspond with FDA reviewers.
    
• Prepared FDA IND amendments.
  
• Searched and interpreted FDA guidelines.
  
• Reviewed Biologic Master Files.
  
• Provided QA function:
  
  • Review of SOPs.
    
  • GLP training.
    
  • Review of preclinical study design, protocols and batch records.
    
  • Review of research study conduct.

• Project Management:
  
  • Provided clinical project management for single and multi-site Phase I and II studies in the US and Australia.
    
  • Led clinical trial team of regulatory and clinical experts.
    
  • Directly supervised CRAs.
    
• Study Set-up:
  
  • Designed and/or authored (phase I/II) protocols and Case Report Forms (CRFs), Regulatory and Master File essential documents, Clinical Monitoring Plans, Study Manuals and Monitoring Guidelines.
    
  • Organized and presented at investigator meetings.
    
  • Prepared Institutional Review Board (IRB) applications including informed consent (ICF) documents.
    
  • Initiated sites; visited sites to prepare staff for conducting studies and enrolling subjects.
    
  • Trained CRAs and study coordinators.
    
  • Planned the supply, randomization procedure and dispensing of investigational agent (study product).
    
• Site Selection:
  • Prepared RFPs for study sites and reviewed proposals.
    
  • Identified and recruited potential investigators and evaluated sites.
    
  • Constructed clinical trial budgets and reviewed site budget proposals.
    
  • Negotiated site budgets to minimize Sponsor costs.
    
• Ongoing Study Management:
  
  • Identified recruitment strategies and improved subject recruitment.
    
  • Communicated with investigators, developed and maintained strong working relationship with investigator and study coordinators.
    
  • Managed study sites, ensured ongoing prospective assessment of study issues, and took corrective action where required.
    
  • Monitored sites and verified the integrity of clinical data.
    
  • Ensured that sites were conducting studies in accordance with the protocol, GCP, ICH and FDA guidelines.
    
  • Tracked study progress and improved site performance by ongoing review of study data (review of Data Management tracking tools) and follow-up with CRAs, investigators and coordinators to take corrective action.
    
  • Generated study newsletters, progress and meeting reports.

• Contributed to the overall team development of a peptide vaccine, for the treatment of patients chronically infected with Hepatitis B virus.
  
• Prepared detailed technical reports and scientific papers.
  
• Analyzed and interpreted results.
  
• Developed problem-solving skills.
  
• Devised hypotheses and planned research projects.
  
• Developed Bioassays

Consultant, Biologics Consulting Group Inc.
San Mateo, CA USA (Sept. 2002 - present)

Pacific Project Coordinator, Collaborative Study Group, Monash Medical Centre, Melbourne, Australia.

Project Manager, Narhex Operations Pty. Ltd., Sydney, Australia.

Business Manager , VYMP Pty. Ltd., Melbourne, Australia.

Clinical Trial Coordinator, Western Hospital, Melbourne, Australia.

Postdoctoral Research Scientist, Cytel Corporation, San Diego, CA.