メディカル・バイオ - 臨床開発リーダー・臨床開発プロジェクトマネージャー

【Job Description Summary】
The Japan Program Clinical Head (JPCH) is responsible for clinical program activities for approval and post approval commitment for Re-examination in Japan. The JPCH is responsible for one or more clinical programs across indications, involving one or multiple compounds. The JPCH closely works with Japan Project Head (JPH) as well as Global Program Clinical Head (GPCH) and inputs the risk benefit assessment for the program(s), and as the member of Global Clinical Team(s) (GCT) provides the inputs regarding the design, implementation, and execution of a clinical development program(s) including post approval commitment to support decision milestones, regulatory requirements, and market access from Japan point of view. The JPCH may contribute to disease area strategy.

■Job Description
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．Play medical lead role in Japan initiated studies in collaboration with GPCH/CDMD
４．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
５．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)
６．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
７．Contribute to development of TA strategies (Rheumatology area)
８.　Provide on-boarding, coaching, and/or mentoring support; develop and foster Clinical Development culture
９. 　Ensure adequate reporting of adverse events / technical complaints / compliance issues in accordance with company procedures
１０． 100% timely delivery of all training requirements including compliance

■Key Performance Indicators
The indicators below are applied for clinical related activities in Japan
Excellence in establishing clinical development and Re-examination strategy across various indications and programs with alignment across functions
Apply effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area
Robust evidence of quality medical/clinical review of trial data, development of CSRs
Support TA through high quality contributions to CDP and protocol reviews
Timely development of quality disease/program clinical standards, publications, and internal/external presentations
Timely delivery and submission of high-quality clinical program data in a cost-effective manner
External acceptance of clinical data and risk-benefit assessments by key decision makers including Health Authorities, pricing, and reimbursement bodies
Well contributed, effective, and engaged GCT(s) and GPT (as needed)
Clearly demonstrate Novartis Values and Behaviors

■休日：完全週休二日制

■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 (Rheumatology 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/or 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 (or intermediate) oral and written English

■職種未経験者：不可