Associate or Manager, Japan Program Clinical Head (Immunology)

<p style="text-align:left"><b>Job Description Summary</b></p>・The Japan Program Clinical Head (JPCH) is responsible for clinical programactivities for approval and post approval commitment for Re-examination in Japan<br>・The JPCH leads disease area strategy discussion and the risk-benefit assessments for the programs(s) that are required for approval in Japan<br>・The JPCH is accountable for the study design, implementation, and execution of clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view, as a member of Global Clinical Team(s) (GCT) and the leader of Japan Clinical Team(s) (JCT)<p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Job Description</b></p><p>1) Lead the JCT and represent Clinical Development on the JPT to achieve <br />valuable clinical program strategy, drive innovation, ensure regulatory <br />approval, and post approval commitment for patients<br />2) Is the single integrative leader for clinical programs to establish <br />clinical trials excellence, high performing JCT &amp; LTT, integrated <br />CD/GCO/Analytics WoW<br />3) Is a member of the GCT as representative of Clinical Development Japan<br />4) May serve as the CD-J Representative on NIBR clinical/project teams in<br />Japan (EAGLE: Early AGile LEadership Team in pharma), JPT: Japan <br />program team in oncology) to drive transition of pre-FIH (First In Human) <br />projects to Transition Decision Point (TDP) for clinical development strategy <br />in Japan<br />5) Play medical lead role in Japan initiated studies in collaboration with <br />GPCH/CDMD<br />6) Post-TDP, lead the development and execution of Japan clinical strategy.<br />Provides Japan inputs to GPCH for developing an endorsed Clinical<br />Development Plan (CDP) in line with the Target Product Profile (TPP) which<br />is designed for successful regulatory approval/market access for one or<br />multiple treatment indications and/or multiple programs in Japan<br />7) Is responsible for Japan input to the creation of clinical components of key<br />documents (e.g., Clinical Trial Protocols (CTPs), Investigator’s Brochures,<br />Clinical Study Reports (CSRs), regulatory documents including<br />maintenance of product licenses, registration dossiers, Re-examination <br />application dossier, value dossiers, pharmacoeconomic dossiers, Core Data <br />Sheet, Periodic Safety Update Report, J-RMP, and clinical benefit-risk</p><p>assessment for license renewals) with high quality and consistency with<br />CDP and TPP<br />8) Together with Patient Safety, provide GPCH with Japan input regarding<br />continuous evaluation of drug safety profile, including safety monitoring of<br />clinical studies and signal detection from post-marketing surveillance (PMS)<br />9) As the medical/scientific expert, contribute interactions with Japan external<br />stakeholders (e.g., regulatory authorities, key opinion leaders, data<br />monitoring committees, advisory boards, patient advocacy groups), Japan<br />internal stakeholders (e.g., JPT, GCO/Study &amp; Site Operations, Research,<br />Translational Medicine, Medical Affairs, Marketing, Pharmacovigilance (PV),<br />Health Economics &amp; Outcomes Research, etc.), and internal decision boards<br />10) Gather latest clinical trial/drug development trend/information <br />and enhance innovative approach in clinical development and <br />post approval commitment to maximize the product value<br />11) Lead clinical related health authority (HA) activities including development <br />of briefing book and answers for questions from HA<br />12) Lead discussion for post approval commitment strategy in JPT and Japan <br />submission team (JST) and contribute to Team for Re-examination <br />excellence (TREE) for PMS and Re-examination activities including the <br />review of Re-examination dossier<br />13) Support JCDH with leading the peer-review of CDPs, CTPs, and other<br />clinical documents across various indications and programs; and with<br />driving excellence across clinical trial strategy, design, and execution as<br />a delegator of regional reviewer<br />14) Contribute to development of TA strategies<br />15) Support/author Japan publication and clinical communication strategy<br />in coordination with MA Japan and Medical Writing, and provides input<br />into key external presentations<br />16) Responsible for medical/scientific training of relevant Japan stakeholders<br />on the disease area and compound/molecule. May serve as speaker for<br />medical/scientific training in Japan<br />17) Lead or serve on Japan process improvement work streams, act as Subject<br />Matter Experts for standard operating procedures or trainings, and/or<br />contribute to other cross-functional or Clinical Development line function<br />initiatives<br />18) Provide on-boarding, coaching, and/or mentoring support; develop and<br />foster Clinical Development culture<br />19) Ensure adequate reporting of adverse events / technical complaints / <br />compliance issues in accordance with company procedures<br />20) 100% timely delivery of all training requirements including compliance<br />21) May serve as CDD-J concurrently depending on project size or resource<br />allocation</p><p></p><p>Education:</p><p>• Advanced degree in life sciences/healthcare (or clinically <br />relevant degree: MD or equivalent, PhD, PharmD degree is <br />preferable) required.<br />Specialization in a subspecialty may be needed. Advanced <br />clinical training/knowledge in medical/ scientific area <br />aligned with TA required.<br /> </p><p>Experience/Professional requirement:<br />• ≥5 years of involvement in clinical research or drug<br />development in an industry environment spanning clinical <br />activities in Phases I through III/IV, including submission <br />dossiers (In case MD holder, equivalent medical experience <br />is needed)<br />• Advanced knowledge of assigned therapeutic area <br />required, with the capability to innovate in clinical <br />development study designs that provide relevant evidence <br />to decision-makers, and to interpret, discuss and present <br />clinical trial or section program level data<br />• Thorough knowledge of GCP and GPSP, clinical trial design, <br />statistics, and regulatory/clinical development process<br />• Experience with submissions and health authorities required<br />• Demonstrated ability to establish strong scientific <br />partnership with key stakeholders<br />• Demonstrated leadership and team management skills <br />with a documented track record of delivering high quality <br />projects/submissions/trials in pharmaceutical or biotech <br />industry<br />• Considerable organizational awareness including extensive<br />experience working cross-functionally and in clinical teams<br />• Excellent management, interpersonal, communication (both <br />written and oral), and problem-solving skills<br />• Excellent negotiation and diplomatic skills </p><p><br />English Skill:</p><p>• Fluent oral and written English</p><p></p><p>Why consider Novartis? <br /> <br />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? <br /> <br />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. <br /> <br />We are Novartis. Join us and help us reimagine medicine.<br /> <br />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。<br />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。<br />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</p><p></p><p>Japan<br />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&#64;novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.<br />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。<br />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 <a target="_blank" href="mailto:midcareer-r.japan&#64;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。">midcareer-r.japan&#64;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。</a></p><p></p><p><b>Be aware of fake job advertisements and job offers</b></p><p>Novartis is aware of employment scams which make false use of our company name or leader’s names to defraud job seekers. Novartis does not make job offers without interview and never asks candidates for money. </p><p>All our current job openings are displayed <a target="_blank" href="https://www.novartis.com/jp-ja/careers">here</a>. If you have encountered a job posting or been approached with a job offer that you suspect may be fraudulent, we strongly recommend you do not respond, send money or personal information.</p><p></p><p><b>偽の求人広告や採用オファーにご注意ください</b></p><p>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。</p><p>ノバルティスでは、面接なしに採用オファーを出すことはなく、候補者に金銭を要求することも決してありません。</p><p>現在の求人情報はすべて<a target="_blank" href="https://www.novartis.com/jp-ja/careers">こちら</a>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。</p><p style="text-align:inherit"><br /> </p><p style="text-align:left"><b>Skills Desired</b></p>Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Data Analysis, Data Integrity, Learning Design, Lifesciences, Risk Monitoring, Trends Analysis