Physician(Up to Director)

A new biopharmaceutical company is seeking to recruit a Physician to their office in Shanghai. The organisation rapidly develops innovative drugs to meet the needs of global patients, focusing on the global development of drugs for autoimmune diseases. With a fast-developing pipeline of drugs entering the clinical stage in the near future, this position is the perfect opportunity to work a dynamic up-and-coming organisation that prides itself on its highly recognisable clinical development capability.

Job Responsibilities:

• Identify and develop clinical research strategies for company products in assigned therapeutic areas.
• Develop the content writing of clinical research related documents mainly including clinical trial protocol, Investigator's Brochure, and clinical study report.
• Review statistical analysis plan, data management plan, etc. to support clinical trial and meet local registration needs.
• Provide scientific expertise to related phase I study for product registration as needed.
• Work as medical monitor in responsible phase III/? studies, resolve scientific issues, and ensure high quality together with study team.
• Contribute to the preparation of the dossier and providing answers to the CDE/FDA/EMA in a timely fashion during any stage of clinical trial proceeding.
• Ensure ICH-GCP, local regulatory and global policy compliance.
• Continuously review and develop SOPs as well as standard documentation tool kits applicable to clinical development.
• Provide professional TA/product related trainings to clinical study team members and other related stakeholders.
• Work as Local Safety Officer to ensure all studies in assigned therapeutic areas strictly follow company SOPs and applicable China/US/Europe laws/regulations.

Skills and Requirements:

• Master or above degree with the major in clinical medicine.
• At least 2 years of international pharmaceutical industry experience working as CRP or medical expert/scientist.
• Familiarity with clinical development strategy drafting, clinical study protocol writing, medical monitoring, and CSR drafting according to ICH guidelines and company SOPs.
• Good understanding of the overall drug development process, clinical trial methodology, China and US regulatory environment, ICH/GCP Guidelines, and related FDA/EMA clinical development guidelines.
• Fluency in both English and Chinese.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Stephen Qin at +86 21 51694107 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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