高级医学总监

面议

苏州市

刷新时间：2024-02-06

职位描述

  We are seeking a Medical Director to lead clinical trials for gene-editing based therapeutics. The role requires a resourceful, well-organized, strategic focused individual to drive multiple operational tasks. The candidate will work closely with clinical operations, researchers, and external CROs to bring early projects into clinical development.

Responsibilities:
1. Design robust clinical studies
2. Develop clinical study protocols and associated clinical study documents
3. Identify and establish relationships with KOLs and principal investigators
4. Select clinical investigators; providing guidance to investigators on a study.
5. Collaborate in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs.
6. Provide medical supervision for contract research organizations and protocol procedures.
7. Provide medical and scientific input in review of clinical data, patient medical safety data, and laboratory data.
8. Provide medical surveillance on Adverse Event (AE), Serious Adverse Event (SAE) reporting, and follow-ups.
9. Author, review written materials and provide editorial comments for clinical study reports and manuscripts.
10. Develop budgets and timelines for the clinical development team.

Minimum Qualifications:
1. M.D. is required.
2. Formal training in the areas of Internal Medicine /Pediatrics / Endocrinology /Neurology or related fields.
3. A minimum of 2+ years of clinical trials and managerial experience in drug development
4. Excellent interpersonal and public speaking skills are required for this high visibility position.
5. Demonstrated ability to work in a matrix environment with cross-functional teams.

Preferred Qualifications:
1. Experience in rare disease would be a plus.
2. NDA / BLA experience is strongly preferred.
3. Global clinical development experience is required, and global filing experience is strongly preferred.
4. Background in gene therapy is preferred.
5. Experience in pre-clinical development is preferred.
6. Portfolio management experience would be a plus.  

其他要求

招聘人数：1人
职能类别：医学总监

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。