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Job Description
Specific Job Requirements
Reporting to the therapeutic head in Clinical Development Japan, this position in Clinical Development plays an integral role in the scientific planning, execution and reporting of Japanese clinical studies for Gilead’s development compounds in inflammation and virology therapeutic area.
Although generally assigned to a specific therapeutic area, this position may support local clinical development activities across development programs including oncology. The overall responsibilities of this position include the following:
1 Acts as the local scientific expert for assigned clinical research activities, addressing questions from internal functions and external Japanese physicians and research scientists.
- Works with Gilead Sciences Inc., (GSI) project teams including biostatisticians to prepare analyses to address specific questions as required.
2 Drive assigned projects forward as Japan project team (JDT) lead with Japan cross functional team members. Interact regularly with Global Development Team (GDT) Lead to exchange project information including strategic aspects. Provide local requirements and needs to GDT Lead.
3 Provides scientific support to Gilead functions including but not limited to GSI Clinical Development, Clinical Operations, Biostatistics, Data Management, Medical Writing, Clinical Pharmacology and Medical Affairs. Provides guidance to ensure scientific and clinical issues are addressed in a consistent manner.
4 Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support Gilead’s development programs.
5 Responsible for the design of Japanese clinical studies including authoring of study concepts and protocol synopses. Works with the Clinical Operations team for the development, finalization and amendment (as applicable) of study protocols.
- Ensures scientific and clinical consistency across Japanese study protocols and with the global development programs.
- Retains overall responsibility for the scientific content and scientific integrity of clinical trials conducted in Japan.
- Proposes membership for ‘Trial Guidance and Publication Committees (TGPC)’ for review by GSI Clinical Development.
- Prepares specific sections of clinical study manuals, Investigator Meeting notebooks and other documents are needed.
- Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis plans. Acts as the Study Director or Medical Monitor for assigned clinical studies in Japan.
6 Prepares and presents （if applicable） scientific information concerning Gilead’s development programs internally and at external meetings as required.
- Prepares abstracts, posters and oral presentations of Gilead’s clinical trial and associated data for Japanese scientific meetings. - Provides input for manuscripts containing Japanese data prior to Journal submission.
- Coordinates the preparation and/or review of data listings, summary tables, study results, scientific presentations & manuscripts for publication
- Critically assesses abstracts, posters, oral presentations and manuscripts received from Japanese therapeutic area experts proposed for submission to local Japanese scientific meetings or Journals. Collaborates with the requestor concerning content.
- Ensures review and approval of all of the above by the respective GSI Project Team prior to submission, presentation and/or publication.
7 Critically assesses requests from Japanese therapeutic area experts for clinical development studies, Investigator Sponsored Trials (ISTs) and Grant requests:
- Ensures alignment of such requests with Gilead’s scientific strategies and global activities
- Ensures all requests are evaluated in accordance with GSI procedures and is responsible for subsequent negotiation of changes and/or communication of Gilead position with Gilead Medical Affairs (if applicable) and the requestor.
8 Responsible for drafting regulatory Briefing Documents and slide presentations for use at PMDA and MHLW meetings. Attends and presents Gilead position at informal and official Consultation meetings with PMDA and MHLW.
9 Working with Regulatory Affairs and the respective GSI Project Team, prepares written responses to PMDA, MHLW and IRB queries.
10 Coordinates the preparation and/or review of regulatory documentation including but not limited to IND annual reports, IND safety reports, Investigator Brochures and J-NDAs.
- Conducts all responsibilities in accordance with Japanese regulatory requirements, industry standards, GCP and Gilead Standard Operating Procedures (SOPs).
Candidates must have the following essential experience:
- Experience with regulatory-related document drafting and query responses
- Experience drafting the clinical module of the CTD (not just reviewing), and preparing responses to PMDA queries, which lead to approval
- Experience drafting briefing documents or protocols for PMDA consultations and preparing responses to PMDA queries
- Strong experience discussing development plans with cross-functional teams such as Regulatory, Operation, Commercial, Market access
- Experience presenting Japan development plans with other functions in Japan and with global teams in the US/EU
- Excellent English and Japanese communication skills
Specific Education and Experience Requirements
・MS degree or above.
・Minimum of 10 years of project leading experience within clinical research / clinical development.
・Experiences in preparing the CTD and query responses in JNDA.
・Leadership and project management skill to drive clinical development of new therapies in Japan.
・Communication skill enabling timely information sharing with GSI and other functions at Gilead Japan. Smooth language skill for English and Japanese, English level is expected at TOEIC> 900 or TOEFL iBT>90.
・Problem solving skill to analyze the problem and develop/execute action plans.
・Medical writing skill to prepare study protocols and regulatory documents related to clinical.
・Negotiation skill with investigators and officials in the Health Authorities to move the study forward.
・Deep knowledge of clinical guidelines and regulatory requirements.
・Extensive experiences in clinical development to put together the best and fastest development strategy.
・Up-to-date expertise in the responsible therapeutic area.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Top Skills
What We Do
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At Gilead, the tangible results of your contributions are evident. Where every individual matters. Where all employees can enhance their skills through ongoing development. And where we start every day with one question: “What’s next?”
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