For Current Gilead Employees and Contractors:

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Job Description

Essential Duties and Job Functions:

Purpose of Role:

• To serve as the local Clinical Operations representative and point of contact for Clinical Operations Asia Pacific, US study teams and investigators, reporting into Associate Director, Clinical Operations APAC

• To partner with US study team and CRO to maintain cross functional study timelines and troubleshoot country/site specific operations issues

• To leverage local knowledge and relationships and to work collaboratively with Gilead affiliate personnel (Medical Affairs, Regulatory, Pharmacovigilance & Epidemiology) to ensure optimal support for Gilead’s clinical development programs and to ensure relevant information from sites is triaged and communicated to the study teams and TA Leads as necessary

• To provide a local perspective and input into clinical development planning, document generation/review and regulatory filing as required.

• To manage local/regional PIV Gilead Sponsored trials as required

• To provide operational support to Medical Affairs in the oversight of local/regional Investigator Sponsored Trials (ISTs)

Job Requirements:

• Must meet all requirements for Clinical Trial Manager position and have demonstrated proficiency in all relevant areas.

• Provides local operational perspective and advice and supports the oversight of international development clinical trials conducted in country/region. This may include assisting with protocol review and study planning, coordination of feasibility and site list validation in collaboration with Medical Affairs, acting as local sponsor contact for investigators and CROs, conducting accompanied monitoring visits, assisting with investigator meeting arrangements and assisting with the resolution of specific operational issues through effective collaboration with Medical Affairs as directed by Clinical Operations Asia Pacific and/or US study teams

• Manages local/regional Gilead sponsored trials as required and supports Medical Affairs in oversight of ISTs within designated program budgets and timelines.

• Maintain operational knowledge of progress and conduct of all studies involving investigators in country/region (Clinical Operations Asia Pacific and US managed)

• Develop knowledge of and good working relationships with investigators involved in clinical research within the country/region

• Partners with functional peers to manage, adjust, and revise project timelines/budgets as necessary. Develops RFPs, contributes to vendor selection, and manages external resources.

• Ensure local consistency and alignment with GSI global processes and procedures

• Communicates project status and issues and ensure project team goals are met.

• Participates in development of SOPs, Clinical Study Reports, INDs, NDAs, and other clinical, regulatory, safety documents as necessary.

• Contributes to development of abstracts, presentations, and manuscripts as necessary.

• Oversees and operationally supports assigned staff performing the role of line manager as required. This might include recruiting, hiring, mentoring, training and managing CPA/CTMA direct reports and supporting their professional development as necessary.

• May determine activities critical to company success and priorities within functional area. Anticipates moderately complex obstacles and client difficulties and implements solutions to achieve project goals.

• May design and use all available vehicles for scientific communication within company.

• Participates in and contributes to regular Clinical Operations Asia Pacific meetings to facilitate information exchange and ensure alignment

• Maintains up to date knowledge of local, regional and global clinical trial legislation

• Serves as an ambassador for Gilead Sciences International and Global Clinical Operations, both internal & external

• Supports Clinical Operations Asia Pacific Associate Director or Director in departmental and process improvement initiatives as required

• National, regional and international travel may be required (about 20-25%)

Knowledge, Experience and Skills:

• Typically requires a BSc in a relevant scientific discipline (or equivalent nursing qualification). A MSc or PhD would be advantageous

• Must have at least 10 years of experience in pharmaceutical industry, preferably in both pharmaceuticals and CROs, with demonstrable expertise in clinical operations and drug development

• Must have at least 4 years of experience in leading country clinical trials activities, regional project management and/or people management

• Excellent interpersonal skills, and demonstrate ability to lead is required.

• Proactive in troubleshooting problems using national and international regulations, guidelines, and by mobilizing relationships with internal/external stakeholders

• Strong communication and influencing skills and ability to create a clear sense of direction is necessary.

• Experience in managing staff as well as mentoring and developing junior staff is desirable.

• Thorough knowledge and understanding of FDA and EMA Regulations, ICH Guidelines, and local GCPs governing the conduct of clinical trials is required.

• Must have a demonstrated ability to successfully develop, implement, manage and complete clinical trials.

• Experience in developing RFPs and selection and management of CROs/vendors.

• Ability to write study protocols, study reports, sections for investigator brochures, and regulatory documents (e.g. IND, DNA, etc.) with little supervision.

• Ability to examine functional issues from a broader organizational perspective.

• Ability to participate in and/or lead departmental or interdepartmental strategic initiatives under limited supervision.

• Functional expertise to initiate, author, or contribute to SOP development, implementation, and training.

• Fluency in English and Chinese, both oral and written communications.

• Must be able to travel, nationally, regionally and internationally as required (about 20-25%)
  

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.