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.

• 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

• Advanced degree in life sciences/healthcare　(or clinically relevant degree: MD or equivalent, PhD, PharmD degree is preferable) required.

• ≥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

• Fluent (or intermediate) oral and written English