※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
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.
■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)
- 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
- 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
- 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
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.