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Hiring Company | 非公開 |
Location | Tokyo - 23 Wards |
Job Type | Permanent Full-time |
Salary | 8 million yen ~ 15 million yen |
【求人No NJB2203242】
■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)
2) Play medical lead role in Japan initiated studies in collaboration with GPCH/CDMD
3) 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
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
Major Activities
JPCH Page 2 of 4
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 GCO/Study Site Operations 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 TA strategies
7) Support Japan publication and clinical communication strategy in coordination with MA Japan and Medical Writing and provides input into key external presentations
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
Minimum Experience Level | No experience |
Career Level | Mid Career |
Minimum English Level | Business Level |
Minimum Japanese Level | Native |
Minimum Education Level | Bachelor's Degree |
Visa Status | Permission to work in Japan required |
■Education:
・ Advanced degree in life sciences/healthcare (or clinically relevant degree: MD or equivalent PhD PharmD degree is preferable) required.
Specialization in a subspecialty may be needed. Advanced clinical training/knowledge in medical/ scientific area aligned with TA required.
■Experience/Professional requirement:
・ ・5 years of involvement in clinical research or drug development in an industry environment spanning clinical activities in Phases I through III/IV including submission dossiers (In case MD holder equivalent medical experience is needed)
・ Advanced knowledge of assigned therapeutic area required with the capability to innovate in clinical development study designs that provide relevant evidence to decision makers and to interpret discuss and present clinical trial or section program level data
・ Thorough knowledge of GCP and GPSP clinical trial design statistics and regulatory/clinical development process
・ Experience with submissions and health authorities required
・ Demonstrated ability to establish strong scientific partnership with key stakeholders
・ Demonstrated leadership and team management skills with a documented track record of delivering high quality projects/submissions/trials in pharmaceutical or biotech industry
・ Considerable organizational awareness including extensive experience working cross functionally and in clinical teams
・ Excellent management interpersonal communication (both written and oral) and problem solving skills
・ Excellent negotiation and diplomatic skills
■English Skill:
・ Fluent oral and written English
Job Type | Permanent Full-time |
Salary | 8 million yen ~ 15 million yen |
Work Hours | 09:00 ~ 17:45 |
Holidays | 【有給休暇】初年度 20日 1か月目から 【休日】完全週休二日制 土・日・祝日、ゴールデンウィーク(4/29 5/5)、夏季・… |
Industry | Pharmaceutical |
Company Type | International Company |