Japan Program Clinical Head

Job Description

固形腫瘍領域において放射性医薬品,診断薬の開発をリードするJPCH(Japan Program Clinical Head)を募集します.
核医学に関する専門知識を活かし,開発戦略の立案から承認申請,市販後の再審査申請まで日本,アジアの固形腫瘍の患者さんに最良となる臨床戦略を考え貢献していきます.日本の承認申戦略立案•実行への貢献,再審査戦略•実行への貢献など幅広く携わります.Globalも含めた社内外ステークホルダーとの協働と,日々science/medicalの知識を更新しながら自ら考えることに興味のある方是非応募ください.

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
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

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

Diversity & Inclusion / EEO

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

Minimum 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