Clinical Leader (Clinical Development Scientist I / II), Solid Tumor Oncology
AbbVie · JP
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About the Role
As the leader of clinical development in Japan, the Clinical Development Scientist (CDS) is responsible for clinical matters, working with internal and external stakeholders to plan, manage, and execute clinical development strategies. The goal is to deliver novel pharmaceutical products and medical devices to patients as early and efficiently as possible, based on medical and scientific rationale and regulatory considerations.
Responsibilities
- Collects and understands information necessary to formulate clinical development strategies.
- Manages external key opinion leaders (KOLs) and gathers information at academic conferences to identify unmet medical needs in Japanese medical practice.
- Understands PMDA review trends, global development strategy for the assigned asset, and development status of competing products.
- Leads the preparation of the Japan Clinical Development Plan (JCDP) to meet regulatory requirements and unmet medical needs, in accordance with the TPP, contributing to product value maximization.
- Leads discussions with Global to reach agreement on clinically related matters during JCDP preparation.
- Leads major discussions with Global and regulatory authorities on clinical issues during development, including meetings with global teams and PMDA.
- Proposes solutions and works with stakeholders to resolve conflicts.
- Accurately interprets clinical study results and develops a submission strategy based on scientifically compelling evidence.
- Prepares the clinical section of the CTD and responds to inquiries from regulatory authorities.
- Oversees the reliable execution of overall study timelines in collaboration with the monitoring team.
- Ensures the safety of subjects in Japan by collaborating with internal medical experts, scientists, the safety management group, and the monitoring team.
- Prepares or collaboratively prepares key study documents, including the scientific rationale document and clinical study report.
- Leads the cross-functional Clinical Working Team.
- Collaborates with relevant departments according to the Medical Collaboration Guidance.
- Provides appropriate information and education to internal staff as needed.
- Conducts responsibilities with minimum CDH support and educates lower-grade colleagues (CDS I).
- Conducts responsibilities without CDH support, educates lower-grade colleagues, and proposes/implements structures and processes to enhance overall team performance (CDS II).
Requirements
- At least 5 years of experience in clinical development or equivalent knowledge of clinical development.
- 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 desirable.
- Clinical Development experience for the assigned therapeutic area, equivalent clinical knowledge, and/or capability to acquire such 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
- 5+ years
- Grade 17 or 18
Education Level
- Graduate from Medical School, College of Nursing, College of Pharmacy, College of Science/Agriculture, or life-science course
- Master's degree or PhD degree preferable
- Medical Doctor, Veterinarian, Pharmacist, or other life-science related degree or license desirable
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.
- AbbVie is an equal opportunity employer committed to integrity, innovation, and making a remarkable impact on people and the community.
- AbbVie actively supports individuals with disabilities in achieving equal opportunities.
Equal Opportunity
- AbbVie is an equal opportunity employer committed to integrity, innovation, and making a remarkable impact on people and the community.
- AbbVie actively supports individuals with disabilities in achieving equal opportunities.