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欢迎加入来凯医药

共同打造一流医药研发企业

开发创突破性新药造福病患


Position:


Medical Director / Manager / Associate



Key Accountabilities

Drive the clinical development plan and compose protocols for oncology agents/products.

 

Key domains include study synopsis/protocols development, and draft/review and finalize clinical study reports by working with CRO staff; Monitor and collaborate with CRO staff with medical expertise to ensure clinical data integrity and quality and provide full medical support to IND and NDA application globally; Medical monitoring and medical review for relative clinical studies; Provide medical supporting for conducting clinical studies; Prepare and host advisory board meeting for relative clinical development

 

Interact externally with investigators for medical communications and investigators engagement; and interact with key global regulatory authorities by request.

 

 

Successful Candidate

1.   Is a visionary leader and mentor of a clinical team and CROs.

2.   A MD or equivalent doctoral degree preferably with focus in Oncology area. Overseas medical training is a plus.

3.   Excellent writing and presentation skills in both English and Chinese.

4.   Strong leadership and collaborative interpersonal skills.

5.   Over 10 years of experience in bio-pharmaceuticals. Multinational national company experience is preferred.  The experiences in the Oncology study design and regulatory requirements is required. The responsibilities of this position include also the medical monitoring the trials and reviewing trial data and handling safety related issues.

 

6.   Experience with successful IND/NDA submissions and approvals and interactions with regulatory agencies is highly desired.

7.   Able to work with a multi-disciplinary team, prioritize tasks efficiently and deliver results timely.

8.   Able to perform thorough reviews of various medical and legal documents in a timely manner.

 

Work independently and think widely as a leader, self-motivated, fast-learner, willing to meet challenges and share responsibilities with partners.

 

Our Offer:

We offer you an open biotech culture, an exciting journey throughout the world of drug clinical research and development. You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific and management skills, and entrepreneur competency. You can also look forward to a flexible working environment, a pleasant and homelike atmosphere as well as competitive incentive package. If you are looking for a big stage for your profession or beyond, if you are willing to walk out of your “comfortable zone” in your career, come and join us!
Please contact us via hr@laeknatp.com.