Senior Medical Director

Highly Competitive
  1. Permanent
  2. Final Signatory
  3. China
Shanghai
Posting date: 04 Sep 2019
ME.KZ.25118_1567587064

An up and coming company based in Shanghai is advertising a vacancy for a Senior Medical Director. The organisation focuses on developing novel treatments of infectious diseases in China, with a pipeline that covers both antiviral and antibacterial areas. This is an exciting opportunity to work with an organisation and bolster a career in the Medical field.

Job Responsibilities:

  • Drafting the synopsis of clinical trials, reviewing full protocols, and being responsible to update the clinical trial protocol and investigator brochure.
  • Working with CRO to monitor the implementation of the protocols, safety of the participants, and integrity of the data during the studies.
  • Reviewing AE/SAE cases and reports.
  • Effectively interacting and communicating with KOLs/disease experts to discuss the design/implementation/update of clinical studies.
  • Taking the lead to write and edit medical writing deliverables (clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis, and integrated summaries from raw data) covering all phases of clinical research for submission to regulatory agencies.
  • Working with Regulatory to make sure they are in accordance with regulations, standards, and guidelines (ICH, GLPs, and GCPs guidelines, company SOPs).
  • Providing scientific and medical support to clinical operation team, regulatory, and R&D team for preclinical and clinical programs.

Skills and Requirements:

  • PhD degree with certified medical practice.
  • 15 years relevant working experience in pharmaceutical/biotechnology/CRO industry related to medical sciences.
  • Clinical experience in a medical specialty of infectious diseases preferred.
  • Familiar with clinical trial principle, ICH guideline, and GCP.
  • Ability to monitor and interpret clinical data and results.
  • Familiar with clinical trial and regulatory environment in China.
  • 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 Kirsty Zhuang at k.zhuang@proclinical.com 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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