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) Is a member of JPT and drive the clinical development in Japan

　　3) May serve as the CD-J Representative on NIBR clinical/project teams in Japan (J-EPT: Japan Early Project team in pharma, JPT: Japan program team in oncology) to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP) for clinical development strategy in Japan

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

　　5) May support Business Development & Licensing (BD&L) activities for Japan clinical assessment

　　6) Post-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

　　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) 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)

　　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, 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

　　10) 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.

　　11) 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

　　12) Contribute to development of TA strategies (Rheumatology area)

　　13) Support Japan publication and clinical communication strategy in coordination with MA Japan and Medical Writing, and provides input into key external presentations

　　14) Drive scenario development for Clinical Development to support decision analysis and optimal resource allocation in Japan program(s)

　　15) 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

　　16) 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

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

　　18) Ensure adequate reporting of adverse events / technical complaints / compliance issues in accordance with company procedures

　　19) 100% timely delivery of all training requirements including compliance

　　20) May serve as JCDM concurrently depending on project size or resource allocation

　　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 (Rheumatology area) may be needed. Advanced clinical training/knowledge in medical/ scientific area aligned with TA required.

　　Experience/Professional requirement:

　　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 (Rheumatology 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/or 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 (or intermediate) oral and written English

　　Why Novartis?

　　766 million lives were touched by Novartis medicines in 2021, and while we're proud of this, we know there is so much more we could do to help improve and extend people's lives.

　　We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

　　We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

　　Imagine what you could do here at Novartis!

　　Accessibility and accommodation

　　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。

　　Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

　　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