Clinical Leader (Clinical Development Scientist I / II), Eye Care-Specialty-Aesthetics
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
- Identifies unmet medical needs in Japanese medical practice by managing external key opinion leaders (KOLs) and collecting information at academic conferences.
- Understands PMDA review trends, global development strategy for the assigned asset, and the development status of competing products.
- Leads the preparation of the Japan Clinical Development Plan (JCDP) to meet Japan’s regulatory requirements and clinically feasible unmet medical needs, in accordance with the TPP, contributing to maximizing product value.
- Leads discussions on clinically related matters to reach agreement with Global during JCDP preparation.
- Leads major discussions with Global and relevant regulatory authorities on clinical issues arising during the development process, including meetings with the global team and PMDA consultations.
- Proposes the most appropriate solution and works with relevant stakeholders to resolve conflicts.
- Interprets clinical study results accurately 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 key study documents, including the scientific rationale document and clinical study report, or works collaboratively in their preparation.
- Leads the cross-functional Clinical Working Team.
- Collaborates with relevant departments according to the Medical Collaboration Guidance (e.g., publications, investigator meetings).
- Provides appropriate information and education to internal staff as needed.
- Conducts responsibilities with minimum CDH support (CDS I) or without CDH support (CDS II).
- Educates lower-grade colleagues.
- Proposes and implements structures and processes to enhance overall team performance within the therapeutic area in clinical development (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 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
- G16
- 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 its Allergan Aesthetics portfolio.
- For more information about AbbVie, please visit us at www.abbvie.com.
- Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Equal Opportunity
- AbbVie is an equal opportunity employer committed to honest business practices, driving innovation, and making a remarkable impact on people's lives and communities.
- We actively support individuals with disabilities in our pursuit of equal employment opportunities.