Clinical Leader (Senior Clinical Development Scientist or Assistant Medical Director), Hematology
AbbVie · JP
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About the Role
The Senior Clinical Development Scientist (Senior CDS) is a highly specialized clinical development professional in Japan, responsible for leading clinical development activities end to end, from strategy planning through regulatory approval, across therapeutic areas. The Senior CDS is expected to oversee multiple projects simultaneously and to exercise sound judgment in novel, complex, or highly uncertain situations. The Senior CDS integrates medical and scientific evidence with regulatory requirements, business impact, and implications for clinical practice to define and execute optimal development strategies. The Senior CDS also serves as a key contributor in cross-functional and external discussions, engaging as an equal partner with other departments, global teams, physicians, healthcare institutions, academic societies, and regulatory authorities to drive decision-making and consensus building. In the absence of an established global development plan, the Senior CDS is expected to formulate a development strategy from the Japan perspective, secure alignment with global teams and regulatory authorities, and lead implementation.
Responsibilities
- Leads clinical development activities end to end, from strategy planning through regulatory approval.
- Oversees multiple projects simultaneously and exercises sound judgment in novel, complex, or highly uncertain situations.
- Integrates medical and scientific evidence with regulatory requirements, business impact, and implications for clinical practice to define and execute optimal development strategies.
- Serves as a key contributor in cross-functional and external discussions, engaging as an equal partner with other departments, global teams, physicians, healthcare institutions, academic societies, and regulatory authorities to drive decision-making and consensus building.
- Formulates a development strategy from the Japan perspective, secures alignment with global teams and regulatory authorities, and leads implementation in the absence of an established global development plan.
- Collects and understands information necessary to formulate clinical development strategies by managing external key opinion leaders (KOLs) and collecting information at academic conferences.
- Identifies unmet medical needs in Japanese medical practice.
- Understands PMDA review trends, the global development strategy for the assigned asset, and the development status of competing products.
- Leads the preparation of the Japan Clinical Development Plan (JCDP) that addresses Japan’s regulatory requirements and clinically feasible unmet medical needs, in accordance with the TPP, and contributes to maximizing product value.
- Leads discussions on clinically related matters to reach agreement with Global during the preparation of the JCDP.
- Leads major discussions with Global and relevant regulatory authorities on clinical issues arising during the development process, including the IEST, Global Study Team Meeting and PMDA preliminary and/or official consultation, to reach agreement.
- Proposes the most appropriate solution and works with relevant 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 the regulatory authorities.
- Manages multiple more complex projects, sets priorities, manages risks, and is responsible for achieving key milestones.
- Steps in immediately and continues decision-making, external coordination, and project management without interruption if another CDS responsible for a project becomes unavailable.
- Organizes options, assesses risks and impact, including regulatory, business, and clinical practice implications, and provides direction in unprecedented or highly uncertain situations.
- Ensures that necessary decisions and communications are carried out promptly.
- Designs clinical development strategy options that maximize product value by considering multiple perspectives, including differentiation versus competitors, pricing, distribution, and overall business viability.
- Leads global proposals and discussions, not only from a Japan optimization perspective, but also with a view to what is meaningful for the global organization.
- Participates as an equal partner in global meetings such as AST and TAPR, and helps drive consensus.
- Leads the development of a plan from Japan and guides it toward agreement with global teams and regulatory authorities, even when no prior global development plan exists.
- Conducts strategic clinical assessments for in-licensed products.
- Brings together relevant functions, such as TAMD/SD, Safety, CSM, Regulatory Affairs, and JASL, to resolve issues with medical institutions, regulatory authorities, or other external parties, including major concerns, major errors, serious complaints, or unexpected serious adverse events.
- Leads the design of discussions, organizes the decision-making process, and develops measures to prevent recurrence when necessary.
- Collaborates with Clinical Site Management (CSM) to ensure that overall study timelines are met.
- Collaborates with TAMD/SD, the PST Lead, Safety, and CSM to ensure the safety of subjects in Japan.
- Prepares key study documents, including the scientific rationale document and clinical study report, or works collaboratively in their preparation.
- Leads the JAST Clinical Working Team.
- Collaborates with relevant departments in accordance with the JD Medical Collaboration Guidance (publication, Investigator Forum, etc.).
- Provides appropriate information and education to internal staff as needed.
- Conducts the above responsibilities without CDH support.
- Educates lower grade CDS/associate and A-MD with CDH.
- Proposes and implements structures and processes to enhance overall team performance in JAST.
Requirements
- At least, 10 years 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 (Holder of master degree or PhD degree is preferable), or equivalent education.
- Preferred, holder of Medical Doctor, Veterinarian, Pharmacist, or other related with life-science related degree or license.
- Clinical Development experience for assigned therapeutic area, equivalent clinical knowledge, and/or capability to acquire equivalent knowledge.
- TOEIC is 850 score 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
- Senior
- 10+ years
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 is preferable
- Medical Doctor, Veterinarian, Pharmacist, or other related with life-science related degree or license is preferred
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.
- We strive 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.
- 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 integrity, driving innovation, making a remarkable impact on people's lives, and contributing to the community.
- We actively support individuals with disabilities in our pursuit of equal employment opportunities.