ノバルティス：Japan Program Clinical Head (CRM)
仕事内容
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.
応募資格(必須経験など)
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)
• 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