Specific Responsibilities and skills for Position *

The NEW position is responsible for execution of phase 1-3 clinical trials across therapeutic areas in Asia Pacific region, in partnership with global clinical operations team and other relevant functions.

This position is opened to the candidate based in Hong Kong/Taiwan/Singapore.

Essential Duties and Job Functions *

• Manages geographical region(s) of a large complex clinical trial and independently manages all components of a small less complex study
•  Manages vendors and maintains cross functional study timelines in partnership with global study team
•  Partners with global study team and CRO to troubleshoot country/site specific operational issues
• Establishes good relationship with key institutions and key opinion leaders (KOLs) in Asia Pacific region including Australia.
• Conducts co-monitoring/oversight and relationship building visits in the region as required
• Provides inputs to the review of relevant documents including protocols, informed consents,case report forms, monitoring plans, investigator brochures and clinical study reports
•  Contributes to development of RFPs and participates in selection of CROs/vendors
•  May be asked to train CROs, vendors, investigators and study coordinators on study requirements
•  Provides knowledge and expertise on country specific regulations and site experience and suitability for development studies
•  May serve as a resource for others within the company for clinical trials management expertise
•  Contributes to development of study budget and ensures effectiveness of site budget/contract process in the region
• Mentors junior team members and may contribute to employee performance management

Knowledge, Experience and Skills

• Must have 7+ years of experience and a BS or BA in a relevant scientific discipline. If the candidate has more experience, Senior Clinical Trials Manager may be offered.
• Have 2+ year regional study management experience in Asia Pacific region
• Have 5+ years site monitoring experience in Hong Kong and/or Asia Pacific region.  
• Well versed in clinical trial processes and requirements in Asia Pacific region
•  Thorough knowledge of Regulatory Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies
•  Prior experience in working in both pharmaceuticals and CROs is preferred
• Advanced project management skills adequate to manage the entire process of a clinical trial
•  Ability to identify issues and adapt to changes
•  Ability to work independently with minimal oversight
•  Ability to lead cross-functional teams internally and externally and mentors team members
•  Excellent teamwork, communication, decision-making and organizational skills are required
•  Working knowledge and experience with Word, PowerPoint and Excel
•  Must have excellent communication skills in English and Chinese (including Mandarin)
•  International and regional travel is required (approximately 20%)

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammatory diseases.

Overview

Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff of more than 9,000 people is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.

Working at Gilead provides you with plenty of opportunities for career advancement in a growing and agile environment while working with highly respected teams.

We would like to invite you to be a part of an organization that has helped millions of people around the world live healthier and more fulfilling lives.