Associate/Manager, Clinical Development Director Japan

SummaryThe Clinical Development Director Japan (CDD-J) is the clinical/scientific and clinical development expert and provides leadership and support to clinical development deliverables and activities within a clinical trial (e.g. clinical trial protocol) including post approval commitment study, under the leadership of the JPCH. The CDD-J hasresponsibilities for post approval phase activities and may also contribute project level activities.

Job Description

1) Supports and if assigned leads delivery of all assigned 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) Provides input into final analyses and interpretation including the development

of the Clinical Study Report(s) (CSRs), publications and internal/external

presentations.

3) Lead discussions regarding assigned trial and study, in Japan Project Team

(JPT), Japan Clinical Team (JCT), Japan Submission Team (JST), Clinical Trial

Team (CTT), Local Trial Team (LTT), Post-marketing Study Team (PST), and

Team for Re-Examination Excellence (TREE)

4) Contribute to development of clinical sections of project level documents (e.g.,

Investigator’s Brochures clinical development plan, briefing books to PMDA

consultation, 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)

5) Create study concept in collaboration with JPCH.

6) Drive execution of the clinical program in partnership with responsible line

functions including CSMs, Global Trial Directors (GTDs), PMS TMa, if

applicable

7) Conducts ongoing clinical data review of the clinical trial data (including

post approval commitment study) with appropriate oversight from Medical

Lead. Work in close collaboration with the data management and statistics

teams to ensure proper data quality and analysis of clinical trial results.

8) Inspection Readiness and interaction with QA - risk assessments, audit

preparation, mock interviews and presentation prep; Author and/or review

presentations and manuscripts of answer for accuracy of clinical data and

content

9) 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

10) As a clinical development 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/JDT, CTT, Research, Translational Medicine, Japan

Medical Affairs, Marketing, HE&OR, PS-J), and internal decision boards

11) Provide on-boarding, training, & mentoring support

12) Contribute to medical/scientific training of relevant Novartis stakeholders on

the disease area and compound/molecule. May serve as speaker for

medical/ scientific training

13) Contribute to initiatives (e.g., process improvement, training, SOP

development, other Clinical Development line function initiatives)

14) May be assigned to lead clinical trial(s) as Clinical Scientific Lead and

provide leadership and guidance for all clinical aspects of a clinical trial in

close collaboration with JPCH and/or CDMD.

15) Identify candidate of CDD-Js and contribute to coach/support CDD-Js, and

cultivate their talent & career development

16) 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)

17) Ensure adequate reporting of adverse events / technical complaint /

compliance issue in accordance with company procedures

18) 100% timely delivery of all training requirements including compliance

19) 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.

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

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 internal and external stakeholders

• Thorough knowledge of ICH, GCP and GPSP, clinical trial/PMS

design and methodology, 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

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

Japan

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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

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偽の求人広告や採用オファーにご注意ください

ノバルティスでは 当社名や幹部の名前を不正に使用して求職者をだます 採用詐欺 が発生していることを認識しています

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現在の求人情報はすべてこちらに掲載されています 詐欺の可能性がある求人広告や採用オファーに遭遇した場合は 返信したり 金銭や個人情報を送ったりしないよう強くおすすめします

Skills DesiredClinical Research, Clinical Trial Protocol, Clinical Trials, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis

REQ-10063785