The Opportunity:

The Director, Clinical Development, Japan will lead the Japan-focused scientific, clinical, and operational scope of assigned study protocols. This role will work with the cross-functional teams for the design, execution, and monitoring of clinical studies, as well as oversee data review, interpretation, and communication to both internal and external stakeholders. Oncology clinical development experience is preferred. 

• Develop and execute clinical development strategies and the Clinical Development Plan (CDP) with a focus on development in Japan.

• Lead cross-functional teams with oversight from senior team members to conduct clinical studies, including study start up, execution and close out activities, data review/analysis, and preparation of study reports.

• Oversee the development of program-level documents, including but not limited to clinical protocols, investigator’s brochure, clinical study reports, abstracts and manuscripts, presentations, and various other internal and external documents and communications as needed in Japan.

• Oversee ongoing data reviews; prepare and present summaries to internal and external stakeholders.

• Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety.

• Represent Clinical Development with Japan-Based internal and external stakeholders (investigators, study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalation.

• Conduct literature reviews as needed.

Required Skills, Experience and Education:

• BS/MS Degree in a scientific discipline with a minimum 8+ years of experience in the pharmaceutical or biotechnology industry as a clinical scientist or related role.

• Proven leadership in a collaborative team setting and driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

• Detail-oriented with ability prioritize tasks and function independently as appropriate.

• Strong organizational skills and an ability to interpret, discuss, and report trial/program level data effectively and identify trends.

• Proficient with software tools (Microsoft Office), Electronic Data Capture, and other custom web-based software.

• Excellent written and verbal communication skills both in English and Japanese.

Preferred Skills:

• Experience in oncology clinical trials.

• Strong experience with clinical data review and data quality assurance.

• Knowledge and experience with clinical trial management and oversight.

• Understanding and experience in clinical trial protocol and regulatory document authoring.

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