Major Accountabilities
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, 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
Major Activities
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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) 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)
16) Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with company procedures
17) 100% timely delivery of all training requirements including compliance

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

Experience/Professional requirement:
• ≥ 3 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. ≥ 3 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.
• Excellent communication skills, written and oral
• Strong interpersonal skills
• Excellent negotiation and conflict resolution skills

English Skill:
• Capable oral and written English

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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 diversityandincl.china@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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