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About the Role

The Clinical Program Leader provides medical leadership for clinical development projects, from early development through Phase III. This role involves defining strategies, overseeing clinical trial protocols, and ensuring effective development of new compounds. The role also includes engaging External Experts in Japan to inform global early clinical development strategy.

Responsibilities

Define Target Product Profiles (TPP), Clinical Development Plans (CDP), and Pediatric Investigational Plans (PIP).
Develop Core Clinical Trial Protocols and provide input to Project Analysis and Data Management Plans.
Prepare Investigator's Brochure and provide medical input to Company Core Data Sheet and Annual Safety Reports/IND Safety Reports.
Provide medical oversight throughout protocol development, study conduct, analysis, and reporting.
Conduct continuous benefit-risk assessment and provide medical leadership during regulatory meetings.
Contribute to submission strategy and regulatory filings, and address safety issues.
Oversee medical project budgets.
Serve as Chairperson of the Global Early Clinical Development (ECD) Team and/or Medical Sub-Team (MST).
Propose team members in collaboration with the (Associate) Therapeutic Area Head.
Represent ECD/MST on Core Team, Therapeutic Area Leadership Committee (TALC), Clinical Expert Committee (CEC), and Human Pharma Steering Committee (HPSC).
Oversee interactions with external experts, advisory boards, adjudication committees, and Safety Data Monitoring Boards.
Review and approve publications related to the project in collaboration with the Medical Head.
Identify studies that should be conducted.
Provide input into Medical Affairs strategic documents, including Scientific Platform, Publication Plan, and Product Maintenance and Optimization Summary.
Map and prioritize External Experts (EEs) in the region, including indication experts, translational clinicians, and Phase II trialists.
Build and maintain relationships with External Experts to obtain scientific input and support trial success.
Facilitate scientific discussions to ensure regional expertise contributes to emerging science and innovation, Proof-of-Concept (PoC) study design, and biomarker strategy.

Requirements

Operates within the requirements of global Standard Operating Procedures (SOPs) and working instructions.
Global nature of the role.
Matrix organization.
Direct multidisciplinary interaction.
Works with global matrix teams, regional BI counterparts, external partners, academic institutions, and investigators.
Interfaces with regulatory authorities, international societies, and other relevant international stakeholders.

Skills

Medical and scientific leadership ability.
Strong project management skills.
Strong communication and presentation skills.
Excellent cross-functional collaboration skills.
Ability to work effectively in virtual teams.
Ability to establish strong partnerships with top external experts, national/international societies, and other stakeholders.
Ability to engage in advanced scientific knowledge exchange.
Fluency in both Japanese and English.

Location

Japan

Work Type

Full-time

Experience Level

Up to 3 years of pharmaceutical industry experience preferred.

Education Level

PhD or MD preferred.
Board certification in a specific Therapeutic Area or equivalent clinical experience.

About the Company

The Clinical Program Leader in Experimental Medicine Japan assumes responsibility for engaging External Experts (EEs) in Japan.