シニアクリニカルサイエンティスト - 製薬会社

お問合せ Yuichi Matsuda
参照 JO-2011-451734
about Yuichi Matsuda

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]
Global Pharmaceutical Company

At company, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

[Responsibilities]
■Functional Area Description
The Japan Senior Clinical Scientist reports through the Japan Clinical Development function which provides scientific expertise necessary to design and deliver clinical studies and programs.

■Position Summary / Objective

  • Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials
  • Successfully leads, plans, and executes trial level activities for multiple trials with minimal to moderate level of supervision
  • Provides scientific and clinical leadership to team of supporting Clinical Scientists (matrix leadership)
  • Co-Leads study team meetings in partnership with GDO/RCO protocol manager; and collaborate with cross functional study team members
  • May support clinical development planning (collaboration with Japan Clinical Development Lead/Japan Clinical Trial Physician for provision and analysis of data to support future planning)

■Position Responsibilities

  • a thorough understanding of assigned protocols and protocol requirements; educate supporting team members Maintain
  • Plan and lead the implementation all study startup/conduct/close-out activities as applicable
  • Evaluate innovative trial designs (collaboration with Japan Clinical Trial Physician/Japan Clinical Development Lead)
  • Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality (collaboration with Medical Writing)
  • Site-facing activities such as training and serving as primary contact for clinical questions
  • Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team
  • Clinical data trend identification; provide trends and escalate questions to Japan Clinical Trial Physician
  • Develop clinical narrative plan; review clinical narratives
  • Provision of information required by Protocol Manager for development of trial budget, CRO scope of work, etc.
  • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities
  • Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
  • Collaborate and serve as primary liaison between external partners for scientific advice

[Requirements]

  • 5+ years of experience in clinical science, clinical research, or equivalent
  • Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
  • Proficient knowledge and skills to support program specific data review, trend identification, data interpretation
  • Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
  • Excellent verbal, written, communication and interpersonal skills
  • Must be able to effectively communicate and collaborate across functions and job levels
  • Ability to assimilate technical information quickly
  • Routinely takes initiative
  • Detail-oriented
  • Strong sense of teamwork; ability to lead team activities
  • Proficient in Medical Terminology and medical writing skills
  • Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
  • Proficient critical thinking, problem solving, decision making skills
  • Understanding of functional and cross-functional relationships
  • Commitment to Quality
  • Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges with confidence and professionalism
  • Proficient planning/project management skills (ability to develop short to mid-range plans that are realistic and effective in meeting goals)
  • Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), J-Review or similar data reporting tools
  • A certain level of spoken and written English for business is required

[Employment Type]
Full time

[Salary]
10M-12M yen
※Experiences and skills will be considered

[Location]
Tokyo


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