Associate or Manager, Japan Program Clinical Head; Immunology

Job Description Summary

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 leads disease area strategy discussion and the risk-benefit assessments for the programs required for approval in Japan. The JPCH is accountable for the study design, implementation, and execution of clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view, as a member of Global Clinical Team(s) (GCT) and the leader of Japan Clinical Team(s) (JCT).

1) Lead the JCT and represent Clinical Development on the JPT to achieve valuable clinical program strategy, drive innovation, ensure regulatory approval, and post approval commitment for patients.
2) Is the single integrative leader for clinical programs to establish clinical trials excellence, high performing JCT & LTT, integrated CD/GCO/Analytics WoW.
3) Is a member of the GCT as representative of Clinical Development Japan.
4) May serve as the CD-J Representative on NI  clinical/project teams in Japan (EAGLE: Early AGile LEadership Team in pharma), JPT: Japan program team in oncology) to drive transition of pre-FIH (First In Human) projects to Transition Decision Point (TDP) for clinical development strategy in Japan.
5) Play medical lead role in Japan initiated studies in collaboration with GPCH/CDMD.
6) Post-TDP, 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.
7) 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, Core Data Sheet, Periodic Safety Update Report, J-RMP, and clinical benefit-risk assessment for license renewals) with high quality and consistency with CDP and TPP.
8) Together with Patient Safety, provide GPCH with Japan input regarding continuous evaluation of drug safety profile, including safety monitoring of clinical studies and signal detection from post-marketing surveillance (PMS).
9) 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, GCO/Study & Site Operations, Research, Translational Medicine, Medical Affairs, Marketing, Pharmacovigilance (PV), Health Economics & Outcomes Research, etc.), and internal decision boards.
10) Gather latest clinical trial/drug development trend/information and enhance innovative approach in clinical development and post approval commitment to maximize the product value.
11) Lead clinical related health authority (HA) activities including development of briefing book and answers for questions from HA.
12) Lead discussion for post approval commitment strategy in JPT and Japan submission team (JST) and contribute to Team for Re-examination excellence (TREE) for PMS and Re-examination activities including the review of Re-examination dossier.
13) Support JCDH with leading the peer-review of CDPs, CTPs, and other clinical documents across various indications and programs; and with driving excellence across clinical trial strategy, design, and execution as a delegator of regional reviewer.
14) Contribute to development of TA strategies.
15) Support/author Japan publication and clinical communication strategy in coordination with MA Japan and Medical Writing, and provides input into key external presentations.
16) 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.
17) 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.
18) Provide on-boarding, coaching, and/or mentoring support; develop and foster Clinical Development culture.
19) Ensure adequate reporting of adverse events / technical complaints / compliance issues in accordance with company procedures.
20) 100% timely delivery of all training requirements including compliance.
21) May serve as CDD-J concurrently depending on project size or resource allocation.

• Advanced degree in life sciences/healthcare (or clinically relevant degree: MD or equivalent, PhD, Pharm

D degree is…