Christopher W. James

About Christopher W. James

As the Clinical Operational lead for several pharmaceutical companies, I have created and…

Experience

1. Vice President, Clinical Operations

   Mesoblast Limited

   Sep 2016 — Present

   As VP of Clinical Operations, I am responsible for strategically planning clinical trials, resourcing, and providing oversight to achieve program objectives and high quality deliverables within established timelines and budgets. Establish operationally effective relationships with Contract Research Organizations and other critical support service vendors to effectively manage our global clinical development programs. Ensure operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes. Recruit, mentor and develop professional relationships to foster a positive and productive working environment. Role model for leadership to the clinical operations team, and across the organization, by effectively communicating a vision for the success of our programs. Establishing a clear strategy for achieving the corporate objectives and fostering team work to ensure timely and high-quality deliverables, demonstrating efficient and clear decision making, practice principles and values that place patients and quality first, and maintaining an “executive presence” to inspire and guide people in attainment of individual and corporate goals. As within most clinical research organizations, this role must identify and effectively manage external vendors to provide high-quality deliverables within established timelines and budgets. Additionally I work collaboratively and communicate effectively with all functional area representatives within senior management, in the project team environment, and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals. Ensure Clinical Operations, strives for quality and is compliant with company policies and procedures, as well as other applicable rules, guidelines and codes of practice required by regulators or law.

Skills

• Fda
• Pain Management
• Clinical Development
• Clinical Research
• Gcp
• Ich-Gcp
• Regulatory Submissions
• Ctms
• Ind
• Pharmaceutical Industry
• Medical Writing
• Pharmacovigilance
• CRO
• Drug Development
• Clinical Operations
• Clinical Monitoring
• Regulatory Affairs
• Clinical Study Design
• Clinical Trials
• Oncology
• Sop
• Infectious Diseases
• Edc
• Endocrinology
• Therapeutic Areas
• Clinical Data Management