Santen Inc., Emeryville, California Dec., 2014 – Present Director, Clinical Data Management• Head of Clinical Data Management (CDM).• Create and implement the CDM SOPs and work instruction guidelines.• Manage business activities of the CDM group.• Oversee day to day CDM support of clinical trials.• Mentor and supervise CDM staff.• Evaluate and supervise CROs and external vendors.• Lead initiatives for CDM infrastructure.• Develop strategic direction of CDM group.

• Head of Clinical Data Management – lead all activities for 20 data managers.• Successful FDA NDA for Cabozantinib (Cometriq) for medullary thyroid cancer (MTC).• Directed the CDM work for 5 simultaneous global phase 3 oncology trials.• Member of the joint sponsor/CRO Oversight Management Teams for four CROs.• Implemented a new EDC system.• Extensive experience with lab data – implemented the use of a local lab data collection vendor.• Put in place a shared data cleaning process that used both CRO and in-house resources.• Responsible for CRO CDM budgets and provided input into corporate CRO selections.• Used a mixture of regular staff and contract data managers to manage the optimum staffing level.• Revised and expanded SOPs and Work Instructions.• Member of the NDA filing teams.

Head of Clinical Data Management

Head of Clinical Data Mangement.Extensive experience managing data management activities performed by CROs.

Global accountability for data management activities for 3 oncology products at the same time.Managed data management activities of team members in US, UK and Japan.

EDC implementation sub-team leader for process documentation.Regularoty filing team leader for CDM activiites for 1 NDA and 1 BLA.

Plan, organize and supervise data management activities for a data management team working on phase 1-3 oncology clinical trials.Represented Clinical Data Management as a member of a Global Development Team.

Correlate CDM activities, including data validation, with Biostatistics, Safety, and Clinical Research.Develop CRFs, author data management plans, perform user acceptance testing of Oracle Clinical database, program edit checks, prepare data for final database lock, adhere to SOPs and GCP and ICH guidelines.

Lead data manager for two pain medication clinical trials.Supervise data entry activities.

Responsible for manufacturing of diagnostic test kits, quality assurance, regulatory affairs, cGMP compliance, budgeting, sales forecasting, customer service and cost containment.

Streamlined manufacturing processes, including cell culture and virology procedures, implemented cGMP compliance program, standardized processes, wrote and revised manufacturing SOPs.

Laboratory research utilizing cell culture, viral, and molecular biology procedures.