Manager - Director, Clinical Research
Manager - Director, Clinical Research
Japan - Tokyo
Gilead Sciences, Inc. is a research-based bio-pharmaceutical 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Reporting to the therapeutic head in Clinical Research Japan (or reporting to the head of Clinical Research Japan in case of Director), this position in Clinical Research plays an integral role in the scientific planning, execution and reporting of Japanese clinical studies for Gilead's development compounds in inflammation, virology and oncology therapeutic area.
Although generally assigned to a specific therapeutic area, this position may support local clinical research activities across development programs. 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.
- a. Works with Gilead Sciences Inc., (GSI) project teams and Biostatistics to prepare analyses to address specific questions as required.
2) Provides scientific support to Gilead functions including but not limited to GSI Clinical Research, Clinical Operations, Biostatistics, Data Management, Medical Writing and Medical Affairs. Provides guidance to ensure scientific and clinical issues are addressed in a consistent manner.
3) Responsible for identifying, establishing and maintaining science-based relationships with Japanese therapeutic area experts to support Gilead's development programs.
4) Responsible for the design of Japanese clinical research 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.
- a. Ensures scientific and clinical consistency across Japanese study protocols and with the global development programs.
- b. Retains overall responsibility for the scientific content and scientific integrity of clinical trials conducted in Japan.
- c. Proposes membership for Trial Guidance and Publication Committees (TGPC)' for review by GSI Clinical Research.
- d. Prepares specific sections of clinical study manuals, Investigator Meeting notebooks and other documents are needed.
- e. Contributes to the design and development of CRFs, Data Management Manuals and Data Analysis plans.
- f. Acts as the Study Director for assigned clinical studies in Japan.
5) Prepares and presents (if applicable) scientific information concerning Gilead's development programs internally and at external meetings as required.
- a. 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.
- b. Coordinates the preparation and/or review of data listings, summary tables, study results, scientific presentations & manuscripts for publication
- c. 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.
- d. Ensures review and approval of all of the above by the respective GSI Project Team prior to submission, presentation and/or publication.
6) Critically assesses requests from Japanese therapeutic area experts for clinical development studies, Investigator Sponsored Trials (ISTs) and Grant requests:
- a. Ensures alignment of such requests with Gilead's scientific strategies and global activities
- b. 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.
7) 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.
8) Working with Regulatory Affairs and the respective GSI Project Team, prepares written responses to PMDA, MHLW and IRB queries.
9) 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.
- a. Conducts all responsibilities in accordance with Japanese regulatory requirements, industry standards, GCP and Gilead Standard Operating Procedures (SOPs).
Knowledge, Experience & Skills:
1) MS degree or above.
2) Minimum of 3-7 years of experience (depending on the grade) within clinical research / clinical development.
3) Experiences in preparing the CTD and query responses in JNDA.
4) Leadership and project management skill to drive clinical development of new therapies in Japan.
5) Communication skill enabling timely information sharing with Foster City and other functions at Gilad Japan.
6) Problem solving skill to analyze the problem and develop/execute action plans.
7) Medical writing skill to prepare study protocols and regulatory documents related to clinical.
8) Negotiation skill with investigators and officials in the Health Authorities to move the study forward.
9) Deep knowledge of clinical guidelines and regulatory requirements.
10) Extensive experiences in clinical development to put together the best and fastest development strategy.
11) Up-to-date expertise in the responsible therapeutic area.
If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community: https://gilead.avature.net/Gilead
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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 inflammation, and serious respiratory and cardiovascular conditions.
For Current Gilead Employees and Contractors:
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