Immunology Japan Program Clinical Head

Job Purpose :

The Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications, involving one or multiple compounds. The JPCH closely works with Japan Project Head (JPH) as well as Global Program Clinical Head (GPCH) and inputs the risk benefit assessment for the program(s), and as the member of Global Clinical Team(s) (GCT) provides the inputs regarding the design, implementation, and execution of a clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view. The JPCH may contribute to disease area strategy.

Major Activities :

1) Is an extended member of the GCT as representative of Clinical Development Japan (CD-J) and is a member of JPT and drive the clinical development in Japan

2) Play medical lead role in Japan initiated studies in collaboration with GPCH / CDMD

3) Post-Drug Development Point (DDP), lead the development and execution of Japan clinical strategy. Provides Japan inputs to GPCH for developing an endorsed Clinical Development Plan (CDP) in line with the Target Product Profile (TPP) which is designed for successful regulatory approval / market access for one or multiple treatment indications and / or multiple programs in Japan

4) Is responsible for Japan input to the creation of clinical components of key documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including maintenance of product licenses, registration dossiers, Re-examination application dossier, value dossiers, pharmacoeconomic dossiers) with high quality and consistency with CDP and TPP. Support registration, market access, commercialization, and maintenance of product licenses (e.g., Core Data Sheet, Periodic Safety Update Report, J-RMP, clinical benefit- risk assessment for license renewals) for the compound(s)

5) As the medical / scientific expert, contribute interactions with Japan external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), Japan internal stakeholders (e.g., JPT, GDO / Trial management, Research, Translational Medicine, Medical Affairs, Marketing, Pharmacovigilance (PV), Health Economics & Outcomes Research, etc.), and internal decision boards lead clinical related health authority (HA) activities including development of briefing book and answers for questions from HA

6) Contribute to development of Immunology strategies

7) Support Japan publication and clinical communication strategy in coordination with MA Japan and Medical Writing, and provides input into key external presentations. Responsible for medical / scientific training of relevant Japan stakeholders on the disease area and compound / molecule. May serve as speaker for medical / scientific training in Japan

8) Lead or serve on Japan process improvement work streams, act as Subject Matter Experts for standard operating procedures or trainings, and / or contribute to other cross-functional or Clinical Development line function initiatives

9) Provide on-boarding, coaching, and / or mentoring support; develop and foster Clinical Development culture

10) 100% timely delivery of all training requirements including compliance