Japan Clinical Development Manager

1.Provide clinical input for all clinical deliverables in the assigned trial including post approval commitment study. Clinical deliverables may include clinical sections of individual protocol/related documents, clinical data review, interim/final study report (CSR), trial related clinical components of regulatory documents/registration dossiers, and publications

2.Lead discussions regarding assigned trial and study, in Japan Project Team (JPT), Japan Submission Team (JST), Clinical Trial Team (CTT), Local Trial Team (LTT), Post-marketing Study Team (PST), and Team for Re-Examination Excellence (TREE)

3.Contribute to development of clinical sections of project level documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, interim/final study report (CSR), J-RMP, Re-examination application dossiers, a report for lifting of “all patient surveillance” as approval condition and responses to Health Authorities)

4.Create study concept in collaboration with JPCH.

5.Drive execution of the clinical program  in partnership with responsible line functions including CSMs, Global Trial Directors (GTDs), PMS TMa, if applicable

6.Ensure ongoing medical and scientific data review of the assigned  trial including post approval commitment study

7.Support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety in Japan

8.As a clinical expert, support the JPCH in interactions with Japan external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., JPT, JBT, CTT, Research, Translational Medicine, Japan Medical Affairs, Marketing, HE&OR, PS-J), and internal decision boards

9.Provide on-boarding, training, & mentoring support

10.Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for medical/ scientific training

11.Contribute to initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

12.Identify candidate of CDD-Js and contribute to coach/support CDD-Js, and cultivate their talent & career development

13.Comply with PMD Act（Pharmaceutical and Medical Device Act）/GPSP（Good Post-marketing Study Practice）, SOPs and other related procedures (including performing all provided training)

14.Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures

15. 100% timely delivery of all training requirements including compliance

16.Lead or serve on Japan process improvement work streams, act as Subject Matter Expert for SOP or trainings, and/or contribute to cross-functional initiatives.

17.Expand our external network and an awareness of industry trend and benchmark.

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 midcareer.japan@novartis.com 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 midcareer-r.japan@novartis.com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。

Education:

• Relevant degree in life sciences/healthcare (or clinically relevant degree) is required

Experience/Professional requirement:       

• ≥ 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV, and PMS. ≥ 5 years of contribution and accomplishment in all aspects of conducting clinical trials or PMS (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry.
• Advanced knowledge of assigned therapeutic area
• Demonstrated ability to establish strong scientific partnership with key stakeholders
• Thorough knowledge of GCP and GPSP, clinical trial/PMS design, statistical analysis methodology, and regulatory/ clinical development process≥ 2 years people coaching/supporting experience required, this may include management in a matrix environment.
• Demonstrated leadership and team management skills.
• Excellent communication skills, written and oral
• Strong interpersonal skills
• Excellent negotiation and conflict resolution skills

English Skill:

• Capable oral and written English

Research and Development: It’s our heartbeat. - YouTube