유명 바이오 제약회사에서 다음과 같이 'Clinical Research Physician'을 찾고 있습니다.
* Position: Clinical Research Physician - Rheumatology
* Department: Medical Team
* Location: Songdo

[RESPONSIBILITIES]
The Clinical Research Physician is involved in the clinical study development, coordination and execution of clinical research and is mainly responsible for all-trial related medical decisions. Tasks include all aspects of clinical research and medical care to the patients in research programs. The main objective of the Clinical Research Physician is to coordinate and perform the tasks associated with clinical research studies.
- Providing scientific and medical knowledge to generate clinical development plan (CDP) for each product in various stages of clinical development
- Scientific & clinical discussion and negotiation on clinical development with major regulatory authorities including US FDA and EMA
- Providing medical and scientific expertise for generation of clinical study protocols, data management plan, statistical analysis plan
- Cooperative work on the preparation and execution of clinical trials with clinical development team and RA team
- Medical consultation and decision making for ongoing clinical trials in therapeutic areas of expertise
- Review and analysis of clinical study results and supervision of clinical study reports
- Scientific support for IND & MAA process
- Contribute to the training and education of medical and scientific issues for internal staff
- Ensures that all established timelines and quality standards are met.
- Supports SOPs, Good Clinical Practices, and all work processes to ensure an efficient and compliant clinical operation.
- Works with clinical research personnel in reviewing laboratory data, performing physical assessments, medical histories, and evaluation of inclusion/exclusion criteria for study volunteers.
- Liaises with the Hospital in their areas of expertise and joint projects.
- Follow processes and adhere to Samsung and project specific standards as well as Health Authority requirements (SOP's, Statistical Analysis Plan, GCP and regulatory guidelines).
- Establish and maintain sound working relationships and effective communication within the Medical team and with other teams.

[QUALIFICATIONS]
- M.D. degree required, specialty of internal medicine preferred with special preference on rheumatology (subspecialty training or serving as an academic position)
- Thorough medical and scientific knowledge in autoimmune and cancer therapeutic area
- Experience in conduction of multicenter clinical trials
- Experience of generation of clinical study documents including protocols, CRF, study reports
- Excellent verbal and written communication skills
- Strong skills in scientific presentation and authoring of study results, either basic or clinical, at global scientific conventions
- Excellent verbal and written communication skills
- Strong skills in scientific presentation and authoring of study results, either basic or clinical, at global scientific conventions
- Have strong analytical, interpersonal and communication skills.
- Ability to develop and interpret policies and to perform multiple tasks
- Accurate, well-organized, sincere, discreet and honest characteristics
- Excellent written and oral communication skills
- Good time management and prioritization skills regarding travel and other duties

Those who are interested in this opportunity, please submit your Resume in MS Word Format by email urgently  Only qualified candidates will be contacted for interview  All resumes not contacted will be kept in DB confidentially for future positions

Kyung Jin KIM
CEO & Executive Search Consultant
Exdigm Inc
Phone: 070-8260-3646
Mobile: 010-8722-1272
Email: ceo@exdigm.com