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About the Role

The Clinical Development Scientist (CDS) leads clinical development in Japan, responsible for planning, managing, and executing clinical development strategies based on medical, scientific, and regulatory rationale to deliver novel pharmaceutical products and medical devices to patients efficiently.

Responsibilities

Identifies unmet medical needs in Japan by managing KOLs and gathering information from academic conferences.
Understands PMDA review trends, global development strategies, and competitor product development status.
Leads the preparation of the Japan Clinical Development Plan (JCDP) to meet regulatory requirements and unmet medical needs, aligning with the Target Product Profile (TPP).
Leads discussions with Global teams to reach agreement on clinical matters during JCDP preparation.
Leads discussions with Global and regulatory authorities on clinical issues during development, including meetings with global teams and PMDA.
Proposes solutions and collaborates with stakeholders to resolve conflicts.
Interprets clinical study results and develops submission strategies based on scientific evidence.
Prepares the clinical section of the CTD and responds to regulatory authority inquiries.
Oversees the execution of study timelines in collaboration with the monitoring team.
Ensures subject safety in Japan by collaborating with internal medical experts, scientists, safety management, and monitoring teams.
Prepares or collaborates on key study documents, including scientific rationale documents and clinical study reports.
Leads cross-functional Clinical Working Teams.
Collaborates with relevant departments according to Medical Collaboration Guidance.
Provides information and education to internal staff as needed.
Conducts responsibilities with minimal or no CDH support (depending on grade).
Educates lower-grade colleagues.
Proposes and implements structures and processes to enhance overall team performance within the therapeutic area.

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 preferred).
MD, 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 English communication skill.

Skills

Leadership
Coaching
Team building
Communication (in Japanese and English)
Facilitation
Medical writing

Location

Japan

Work Type

Full-time

Experience Level

Minimum 5 years

Education Level

Graduate degree (Master's or PhD preferred)
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 focuses on immunology, oncology, and neuroscience, with products and services in its Allergan Aesthetics portfolio.
Company website: www.abbvie.com
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Equal Opportunity

AbbVie is an equal opportunity employer committed to integrity, innovation, and making a remarkable impact on people's lives and communities.
Actively supports individuals with disabilities.