Japan Development Team Lead - 製薬会社

勤務地 Tokyo, Japan
職種 正社員
給与 ¥11000000.00 - ¥14000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
Sub-specialization 臨床試験 / CRA / CRC,
お問合せ Yuichi Matsuda
参照 JO-2011-451736
about Yuichi Matsuda

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

[Company Description]

■Position Summary / Objective
・JCDLs (expert) are matrix leaders who lead, develop, motivate and achieve results through teams
・Serves as the clinical point of accountability for the Japan Development Team and is responsible for the overall Japan clinical development plan for asset(s) in one or more indication(s)
・Engage and collaborates with company's global/alliance counterpart to align with Japan strategy as a representative of company in assigned disease area or assets
・Ensures studies are aligned with target label indications and are designed to meet regulatory, quality, medical, and access goals to fit Japan specific requirement/situation
・Serves as a matrix leader of Japan development team to lead, develop, motivate and achieve results through teams
・The JCDL (expert) reports to Early/late stage development director

■Position Responsibilities
Japan Development Leader parts
・Accountable for driving the execution of the Japan strategy in partnership with the Development Project Manager.
・Represents the program to fit Japan specific requirement to enable timely and well-informed decision making at major stage gates
・Engages global development team, Japan senior leaders and functional area stakeholders to ensure alignment of Japan program strategy and operational plans with functional area capabilities
・Leads and manages the cross functional Japan development team to:
- Assess Japan business opportunities informed by scientific, regulatory, clinical and commercial aspects
- Holistically assesses data needs for Registrational and Non-Registrational Data Generation for Japan
- Proactively identifies potential risks and drives the execution of mitigation strategies
- Interpret and communicate key clinical trial results and regulatory milestones to appropriate governance boards
- Develop a data generation strategy that addresses both regulatory and reimbursement needs for Japan
- Partner with both internal and external teams to develop and execute a Publication Strategy for Japan
- Oversee relevant sub-teams (e.g. Japan study team) and ensures clear goals and performance standards are in place, provides feedback and coaching, and holds sub-team leaders accountable for key deliverables
・Builds and maintains collaborative relationships with external stakeholders (Opinion Leaders, Strategic Alliance Partners, Patient Advocacy Leaders, Health Authorities)
・Actively supports Investor Relations and Public Affairs in managing external ◎◎ communications in Japan

■Clinical Development / Clinical Science parts
・Accountable for the clinical contribution to the development of each indication strategy, including registrational and non-registrational studies, with the support of the CTPs and/or Clinical Scientists (CS) within the asset and/or indication
・May serve as clinical trial physician (CTP) or clinical scientist (CS) as necessary
・Accountable in partnership with the Clinical Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work to proactively partner with these roles
・Accountable for clinical content for CSRs, regulatory reports, briefing books and submission documents
・Champions a quality-focused mindset and ensures adherence to GCP and compliance obligations for clinical conduct
・Represents Clinical Development in both internal and external forums as the consulted authority for the disease area, including within Business Development function
・Provides clinical leadership and disease area expertise into integrated disease area strategies
・Partners closely with KOLs in specific indications
・Serves as Primary Clinical Representative in Regulatory interactions
・Collaborates with other relative functions to develop asset level risk management plan for Japan, resolves issues with other relative functions, and raises to global DT or senior leaders as needed
・Sets executional priorities and partners with CTP,CS and operation team to support executional delivery of studies

■Accountable for top line data with support of CTP, CS, and Statisticians

■Degree Requirements
・MD/PhD/PharmD/MS preferred
・A minimum of 5 years of clinical development / industry experience preferred

■Experience Requirements
From development program lead
・Experience of drug development in (input relative disease area) is preferable
・Experience in managing/leading high performance, cross-functional teams (matrix) or complex organizations successfully in Japan

From CDL

From legacy JDTL

■Key Competency Requirements
From Development Program Lead

From CDL

From legacy JDTL

■Travel Required
・Domestic and International travel may be required.

[Employment Type]
Full time

11M-14M yen
※Experiences and skills will be considered


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