Amber Fang



 Clinical 
  • Work with management team on China products development strategy and tactics 
  • Responsible for the oversight of pre-marketing, post-marketing clinical studies and Investigator Initiated Trials 
  • Provide leadership to the clinical study team to support and ensure the quality of clinical studies; and, that they are e completed within budgets and timelines Manage cross-functional communication (sales, marketing, medical affairs, statistician, regulatory, compliance,etc.) for China clinical plan, including publications, clinical workshops and other clinical activities 
  • Deliver clinical message and training to sales and marketing team to support business 
  • Visit CFDA reviewers to ensure the regulations and requirements are met for new product launch and license renewal 
  • Internal responsibilities:Conduct clinical trials in China to provide clinical data in support of China product development and provide clinical training to cross functional teams to support the business 
  • External responsibilities: Develop and maintain good relationships with CROs and KOLs to run the clinical studies and build strategic partnerships in China 
  • As country leader in the study, setup country goals, study timelines and resource plan, energize and develop team members to reach the goal 
  • Provide input to cross functional project teams for new product launch strategy and planning 
  • Responsible for project management, including budget/WBS setup, site selection, site visit report review and sign off, investigational product supply, sample exportation, organize investigator’s meeting, review and tracking expense on trials, communication with project team and vendors, and control study quality 
  • Responsible for site feasibility, initiation, recruitment, monitoring ; and, developing and maintaining good relationships with investigators 

People Management 
  • Create SOPs for Project Management, Clinical Monitoring and Training 
  • Create staffing plan for Project Management Department by identifying resource requirements, and work with Human Resources for resource needs 
  • Provide the leadership for Project Management Department and setup department goals and individual goals Recruit, coach and motivate Project Managers and other team members
  • Provide technique, business, compliance and other study related training to all project managers 
  • Responsible for interviews, recruitment, training and employee retention 
Project Management 
  • Provide input for study design, protocol and Informed Consent development and other study specific documents 
  • Work on the study plans, including budget and FTE forecasting, recruitment plan, communication plan, risk assessment and contingency plan, training plan and etc. 
  • Oversee the progress of all the clinical research projects to make sure the compliance with company policies, procedures and regulatory requirements Manage cross-functional project team, facilitating the team’s ability to fulfill their responsibilities in accordance with project specifications 
  • Function as primary liaison between client, third party vendors and project team for project issues, including initiation, planning, execution and close-out of assigned studies 
  • Develop and maintain project metrics, timelines, budget and deliverables including project plans, trackers and tools for assigned projects 
  • Participate in business development activities and departmental task force initiatives as required 
Therapeutic Areas of Focus: 
  • Cardiovascular: Anti-coagulation, Cardiac Surgery 
  • Endocrinology and Metabolism: Diabetes 
  • Oncology: mGC, mBC, NSCLC 
  • Virology: HBV, HCV 
Education:
Fudan-Norwegian Business School MBA
Fudan University Pharmacology, Bachelor

Employment History:
NAMSA (2016-Present)

Director of Clinical Research

China Edwards LifeScience (2012 –2016)
Senior Clinical Manager
Mar/2015 Clinical Manager

WuXi AppTec Clinical Research Ltd. (2012)
Senior Project Manager

Theorem (Omnicare) Clinical Research (2010 – 2011)
Project Manager

Roche Pharmaceuticals (2007 – 2010) 
Principal CRA / Manager Level 1
Senior CRA
CRA

Shanghai Tongji Hospital of Tongji University (2001 – 2007)
Clinical Pharmacist
Resident Doctor: Rotated in Gastroenterology, Endocrinology, Respiratory, Nephrology, Neurology department and etc. Two years in CCU and Cardiovascular Division;
Clinical Research: Observe efficiency of new medications, report AEs/SAEs.

Publications: 
  • Considerations on Project Management of Clinical Trials in China. Chinese Journal of New Drugs 2014, 23 (8): 885-888. 
  • Medical Device Regulations that Entrepreneurs Need to Know. International Medical Device 2015, 21 (4): 66-68