다음과 같이 국내 유명 바이오 제약회사에서 ‘임상의학 Senior Manager’ 담당자를 찾습니다.

* Job Title: 임상의학

* 직급: 수석급

[RESPONSIBILITIES]

- Manage multi-disciplinary clinical trial teams to ensure all trial deliverables are met according to timelines, budgets, quality, and operational procedures.  

- Manage clinical trial meetings, report study progress and issues, and provide resolution and action plans if necessary.

- Accountable for clinical trial protocols and related documents.  Contribute to the development/review of study related documents, plans, and processes.  Prepare/review training materials and presentations related to the planning and conduct of the trial(s).

- Accountable for the development, management, and forecast of study budgets/invoices

- Responsible for managing CRO(s) and vendors to ensure adherence to scope of work within timelines and budget.

- Ensure ongoing medical/scientific review, final analysis, and interpretation including the development of clinical trial reports, publications, and internal/external presentations.

- Responsible for the development of clinical sections of regulatory documents like IB, briefing books, safety updates, IND/NDA submission documents, and responses to Health Authority questions.

- Demonstrate understanding of the drug development process and provide scientific feedback on due diligence activities

- Manage resolution of trial operational issues, provide updates on trial progress, and mentor/provide guidance to team members

- Review Site visit reports, take actions within the timeline specified and escalate issues and ensure appropriate documentation of issues

[QUALIFICATIONS]

- 학력 : 학사이상

- 전공 : 약리학, 조제학 및 생명과학  

- 해당 업무 분야 10년 이상의 경력 

- GCP, 임상 시험 설계, 규제 프로세스 및 글로벌 임상 개발 프로세스에 대한 지식

- MS PPT/Word/Excel 능숙

- 영어 능통자 우대 

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

Email: ceo@exdigm.com