技能/経験

■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 drugdevelopment 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 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 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 extensiveexperience 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 oral and written English