ノバルティス ファーマ：Clinical Development Director Japan
仕事内容
The Clinical Development Director Japan (CDD-J) is the clinical/scientific and clinical development expert and provides leadership and support to clinical development deliverables and activities within a clinical trial (e.g. clinical trial protocol) including post approval commitment study, under the leadership of the JPCH. The CDD-J hasresponsibilities for post approval phase activities and may also contribute project level activities.
応募資格(必須経験など)
Education:
• Relevant degree in life sciences/healthcare (or clinically relevant
degree) is required
Experience/Professional requirement:
• ≥ 5 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. ≥ 5 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≥ 2 years people
coaching/supporting experience required, this may include
management in a matrix environment.
• Demonstrated leadership and team management skills.
• Excellent communication skills, written and oral
• Strong interpersonal skills
• Excellent negotiation and conflict resolution skills
English Skill:
• Capable oral and written English