临床科学家 Clinical Scientist

职位介绍：

A. Supports to create, revise and maintain study design and outlines, scientific rationale, study protocol aligned with China development strategy and the clinical study plan.

B. Support to implement study protocol including knowledge transfer to clinical study execution in China.

C. Support create and update the study related documents, including medical review plan/summary, Investigator’s Brochure (IB) (Chinese translated version), training materials for study team, etc.

D. Play a key role in the medical review of the data for the local/regional studies, including medical review on eligibility, efficacy, safety, coding, protocol deviation, etc. In addition, handle medical inquiries from/to data management, study operation team or investigators.

E. Participate in investigator meetings, ensuring investigator engagement and managing sites to ensure study treatment discontinuation decisions are made per protocol and aligned with partners within the study team.

F. Work with safety, data management teams and Data Monitoring Committee to make timely decisions regarding study objectives.

G. Supports to create Clinical Study Report (CSR) of the local/regional study, or Chinese cohort report of the global study.

H. Supports to create regulatory filing documents.

I. Communicate and cooperate with internal and external customers.

J. Develop and maintain academic relationship and collaboration with KOLs and other critical stakeholders.

职位要求：
A. Education /Training background:
A graduate degree of clinical, biomedical, pharmacy, nursing, scientific degree with drug development experience is required. A MD or Ph.D. is strongly preferred.

B. Knowledge/Skills:
Expertise of therapeutic area and knowledge of relevant products is highly desired.
Knowledge of clinical development process and HA (especially CFDA) requirements.

C. Job experience:
Proven clinical drug development or medical affairs experience within a pharmaceutical company.

D. Competency:
1) High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to clinical research and the highest personal and ethical standards

2) Ability to acquire and assimilate knowledge in different disciplines, disease, products and therapeutic areas

3) Analytical thinking

4) Excellent communication and team collaboration skills

5) Good presentation skills

E. Others:

Excellent English abilities of listening, speaking, reading and writing; same level of CET-6

工作地点：
Beijing