An innovative biopharmaceutical company is advertising a vacancy for a Clinical Scientist. The organisation focuses on introducing cutting-edge global medical innovation to China and transformative Chinese medical innovation to the rest of the world. This is an exciting opportunity to join a dynamic and ambitious company and bolster a career in the life sciences industry.
- Provide scientific and clinical expertise for Go or NOGO decisions.
- Design clinical development programs in accordance with target product profile by collaborating with relevant functions.
- Lead clinical development plans and take responsibility for study designs; develop study protocol to meet scientific and regulatory requirements for product registration.
- Provide scientific and clinical expertise to clinical sections of regulatory documentations and submissions.
- Act as a speaker at internal and external meetings to provide state-of-the-art medical knowledge of R&D projects as required.
- Be accountable for timely medical monitoring of clinical trials and ensure study protocols are implemented with good medical quality.
- Lead scientific interpretation on clinical trial data and ensure clinical study report reflect scientific value with regulatory required content.
- Be accountable for scientific and clinical advice and training to other functions within the organisation.
- Build, maintain, and leverage networks internally and externally in order to ensure continuous medical quality and performance.
- Contribute to publications produced via clinical trials and present data at medical conferences on behalf of the company
- Guide junior team members for the assigned clinical programs, becoming involved in the process optimization for clinical development.
- Conduct peer-review of clinical development documents across various indications and pro- grams.
- Contribute to medical and scientific evaluation for Business Development & Licensing opportunities.
Skills and Requirements:
- Master's degree or above in clinical medicine.
- 5 years clinical experience ideally.
- 7 years protocol design or trial medical monitoring experience in pharmaceutical enterprise or CRO.
- Strong scientific and clinical education/experience with an adequate network and connections to experts/KOLs in the responsible therapeutic areas.
- Extensive knowledge of trial design, statistical methods, data analysis, and medical writing.
- Profound knowledge of pharmaceutical business, drug development and regulatory processes, expertise of GCP, and applicable guidelines of clinical development guidelines.
- Ability to anticipate and facilitate issue resolution to meet local registration requirements.
- Fluency in Chinese and English.
- 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.
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 email@example.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing 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.