About the Role

　　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

　　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

　　Novartis is committed to working with and providing reasonable accommodation to

　　individuals with disabilities. If, because of a medical condition or disability, you need a

　　reasonable accommodation for any part of the recruitment process, or in order to

　　perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact

　　information. Please include the job requisition number in your message.

　　ノバルティスは障害を持つ個人と協力し、合理的配慮を提供することをお約束しま

　　す。

　　健康状態や障害を理由に採用プロセスのいかなる部分においても、あるいは職務の

　　必須事項を果たすために合理的配慮が必要な場合は [email protected]

　　宛てに電子メール

　　をお送りください。その際ご依頼内容、ご連絡先、求人票の番号を明記してくださ

　　い。

　　Diversity & Inclusion / EEO

　　We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

　　Role Requirements

　　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

　　Division

　　Development

　　Business Unit

　　CD&A GDD

　　Location

　　Japan

　　Site

　　Tokyo

　　Company / Legal Entity

　　Novartis Pharma K.K.

　　Functional Area

　　Research & Development

　　Job Type

　　Full Time

　　Employment Type

　　Regular

　　Shift Work

　　No