Wendy Currlin

About Wendy Currlin

Over 20+ years experience in clinical research as a Program Director, Project Manager…

Experience

1. Director Clinical Operations

   Ionis Pharmaceuticals, Inc.

   Apr 2022 — Present

   Responsible for providing Clinical Operations leadership to clinical projects as Clinical Program Lead. As the Clinical Operations subject matter expert, collaborates with other functional areas to ensure successful execution of protocols; achieving quality, timely completion, and on-target spending. • Oversees study vendors and contractors to ensure clinical trials are executed with high quality and within timelines and established budget parameters • Achieves high quality execution of clinical trials that are in compliance with GCP and regulatory requirements • Leads project specific meetings with executive management team • Identifies operational issues across protocols and ensures resolution • Implements best industry practice standards across assigned studies • Provides strategic and tactical guidance in risk management of clinical trial execution; develops and executes risk mitigation plans • Provides guidance on the development and implementation of clinical protocols • Negotiates vendor contract terms and ensures proper execution • Leads vendor selection activities; establishes vendor oversight expectations and ensures proper execution of the vendor management plans; establishes and monitors Key Performance Indicators • Participates in process improvement initiatives to increase quality, productivity, and efficiency • Participates in Quality Assurance efforts • Represents/leads Clinical Operations in regulatory inspection activities • Participates in the development and management of project budgets; proactively manages study budgets, including accurate forecasting and cost accruals • Maintains optimal relationships with key internal partners and stakeholders to enable successful execution of trials • Anticipates project needs and implements solutions • Serve as direct line manager for Clinical Operations team members; conducts annual performance evaluations

Skills

• Drug Development
• Clinical Monitoring
• Protocol
• CRO
• Neurology
• Clinical Trials
• Regulatory Affairs
• Phase Ii
• Clinical Development
• Clinical Research
• Biotechnology
• Regulatory Requirements
• Sop Development
• Gcp
• Trial Management
• Ctms
• Data Management
• Sop
• Oncology Clinical Research
• Phase I
• Clinical Data Management
• Clinical Operations
• Edc
• Ich-Gcp
• Cross-Functional Team Leadership
• Infectious Diseases
• Phase Iii
• Patient Recruitment
• Rare Diseases
• Pharmaceutical Industry
• Cardiology
• Central Nervous System
• Capa
• Therapeutic Areas
• Oncology
• Project Management