※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
■Position Summary / Objective
- Demonstrates strong leadership to develop Japan strategies with early oncology compounds and to execute development plans aligned with therapeutic area strategy and timeline with high standard of quality.
- Oversights team's activities to ensure quality of execution.
- Provide input to senior leadership team for effective decision-making and execution.
- Engage and collaborates with company global/ company /alliance counterpart to align with Japan strategy as a representative of company in assigned therapeutic area.
- Reports to Oncology TA head of clinical development, company
- Is the direct manager to JCDLs (expert), J Clinical Trial Physicians (CTPs) and J Clinical Scientists (CSs)
- Leads the Japan early development team for oncology clinical development
- Responsible for managing CDL(s), CTP(s) and CS(s); attracting, developing and retaining top talent; ensuring appropriate training and mentoring of CTP s and CSs
- Oversights the cross functional Japan development team activities through CDL(s), CTP(s) and CS(s)
- To ensure that Japanese PK/PD and safety data is generated in a timely and strategic manner for participation of registration trials
- To creates and ensure execution of the overall clinical development plan for assets in one or more tumor types. Solicits and integrates input from statistics, regulatory, outcomes research, medical, commercial and other experts.
- To ensure that studies are aligned with target label indications and commercial goals, and are properly designed and conducted in a timely and cost efficient manner.
- Ensure adherence to GCP and compliance obligations for clinical conduct
- Oversees the review of safety and efficacy data across the program and integrates this information in order to detect relevant patterns and makes study modifications or start/stop recommendations as needed.
- Responsible for the review and/or creation of key study documents
- Initiates, develops and maintains key relationships with internal and external stakeholders.
- Provides medical and scientific expertise to our colleagues in drug discovery, labeling, regulatory, outcomes research, and marketing/commercial departments. Provides scientific/medical input to, and reviews various study plans which are implemented by the operations group. Advises creative solutions for operational obstacles. Provides medical/scientific perspective regarding pricing, reimbursement, quality of life, publications needed at launch, lifecycle management etc. in order to achieve the programs commercial objectives.
- Play JCDLs (expert) and/or JCTPs. if needed
- MD/PhD/PharmD is preferred
- A minimum of 5 years of clinical development / industry experience is required
- Expertise in clinical development (design, execution, analysis and publication of clinical trials)
- Experience with clinical components of regulatory submissions and clinical presentations to regulatory authorities
- Oncology experience in industry and/or oncology practice/research background is preferred
- Strong leadership skills with proven ability to lead and work effectively in a team environment
- Proven strategic thinking
- Good learning agility
- In-depth insight on drug development
- Good communicator and collaborator
- Fluent in English (spoken and written)
※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.