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About the Role
The Clinical Development Strategist (CDS) collects and understands information necessary to formulate clinical development strategies. The CDS identifies unmet medical needs, understands regulatory trends, and contributes to maximizing product value by leading the preparation of the Japan Clinical Development Plan (JCDP). This role also involves leading discussions on clinical issues with global teams and regulatory authorities, interpreting clinical study results, and developing submission strategies.
Responsibilities
- Lead the preparation of the Japan Clinical Development Plan (JCDP).
- Lead discussions on clinically related matters with Global teams.
- Lead major discussions with Global and regulatory authorities on clinical issues.
- Propose and implement solutions for conflicts during development.
- Interpret clinical study results and develop submission strategies.
- Prepare the clinical section of the CTD and respond to regulatory inquiries.
- Oversee the reliable execution of study timelines in collaboration with the monitoring team.
- Ensure the safety of subjects in Japan in collaboration with internal teams.
- Prepare key study documents or collaborate in their preparation.
- Lead the cross-functional Clinical Working Team.
- Collaborate with relevant departments according to Medical Collaboration Guidance.
- Provide appropriate information and education to internal staff.
Requirements
- At least 5 years of experience in clinical development or equivalent knowledge.
- Graduate from Medical School, College of Nursing, College of Pharmacy, College of Science/Agriculture, or life-science course (Master's or PhD degree preferable), or equivalent education.
- Holder of a Medical Doctor, Veterinarian, Pharmacist, or other life-science related degree or license is preferred.
- Clinical Development experience for the assigned therapeutic area, equivalent clinical knowledge, and/or capability to acquire equivalent knowledge.
- TOEIC score of 800 or higher, or equivalent skill for English communication.
Skills
- Leadership
- Coaching
- Team building
- Communication (in Japanese and English)
- Facilitation
- Medical writing
Location
- Japan
Work Type
- Full-time
Experience Level
- CDS I (G16)
- CDS II (G17)
Education Level
- Graduate from Medical School, College of Nursing, College of Pharmacy, College of Science/Agriculture, or life-science course
- Master's degree
- PhD degree
- Medical Doctor
- Veterinarian
- Pharmacist
About the Company
- AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
- AbbVie strives to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
Equal Opportunity
- AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
- Equal Opportunity Employer/Veterans/Disabled.