Location: Shenzhen/ Shanghai, China

Key Responsibilities:

• Contribute to clinical trial documentation development, including but not limited to clinical study protocol (synopsis), clinical study report, trial disclosure form, publication, etc

• Provide medical evaluation and support in early assessment, work out (as one of the key member) drug development strategy and clinical development plan

• Contribute to pre-IND/IND package preparation, application and communication with health authorities

• Take medical lead in clinical study implementation, and perform medical monitoring to ensure patients’ safety

• Contribute to NDA/BLA strategy, package preparation, submission and related communication with Health Authorities

• Conduct KOL mapping and effectively communicate with KOL to maintain solid scientific relationship, understand Chinese clinical practice and clinical requirements.

• Lead product life cycle management and new indications extension

• Provide strategic support to products and company development, including but not limited to external collaboration

Requirements:

• Master’s degree in Medicine with specialty training, or above

• M.D. with over 2 years of relevant medical practice is preferred

• Over 5 years of experience in pharmaceutical industry environment, experience of new product launch is preferred

• Well established TA medical knowledge and well-understood to regulatory guidance for ICH/GCP

• Experience of clinical study design, medical monitoring, CSR authoring, new drug early assessment, health authority communication is preferred

• Academic network in related TA is a plus

• Well-developed of time management skill and ability to determine and prioritize workload

• Well-developed of other soft skill including but not limited to presentation, analytical and interpersonal skills

• Strong business acumen, master of business administration is a plus

Contact

careers@hightidetx.com