Associate Director, Clinical Development

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At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. 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 subsequ

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