Associate/Manager, JPCH

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 NIBR 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

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

Why consider Novartis? 
 
817million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? 
 
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges. 
 
We are Novartis. Join us and help us reimagine medicine.
 
ノバルティスの製品は約8億人以上の患者さんに世界中で届けられています。
約10万の社員が世界中のノバルティスで働いており、その国籍は約147カ国に及びます。
ノバルティスファーマ株式会社は、スイス・バーゼル市に本拠を置く医薬品のグローバルリーディングカンパニー、ノバルティスの日本法人です。ノバルティスは、より充実したすこやかな毎日のために、これからの医薬品と医療の未来を描いています。詳細はホームページをご覧ください。https://www.novartis.co.jp

Japan
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