medical lead

面议

北京市

刷新时间：2024-04-09

职位描述

Position requirements
1.Graduate of a recognized school of medicine with an M.D. degree or equivalent.
2.Specialty training and/or clinical experience and strong academic track record in oncology, Immuno-Oncology, Tumor Immunology, or Immunotherapy.
3.Experience in designing, monitoring and implementing early phase clinical trials and interpreting trial results, including an understanding of biostatistics and safety reporting.
4.Ability to contribute to decision-making and reaching alignment in order to meet challenging timelines.
5.Ability to communicate effectively with internal stakeholders as well as external partners and collaborators; good presentation skills.
6.Understanding of pharmaceutical industry R&D, particularly of PK/biomarker/Translational research and of why nonclinical toxicity arises and what can be done to monitor/overcome it.
7.Understanding of the interplay between clinical development, lifecycle management, commercial objectives and regulatory requirements.
8.Specialist / Board Certification in Oncology is preferred.
9.Direct industry drug development experience preferably.
Experience with hematological or solid tumor malignancies.
Position  statement
Design the study and write/review the clinical study protocol and amendment, ensure the study protocol adherence, in particular the eligibility criteria, safety management guideline, GCP.
Develop safety monitoring plan and medical data review plan (with CRO).
Approve patient enrollment, monitor the safety of each patient enrolled, review the narratives of SAE or AE of special interests (with CRO).
Medical communication with PI and site.
Collaborate with Data Management to design appropriate CRFs/EDC.
Routine medical review of EDC, guide clinical data analysis, TFL preparation.
Write/review the clinical/regulatory documents, CSR, IB, IND/DSUR etc.
Select appropriate sites for the clinical study in collaboration with clinical operation.

其他要求

招聘人数：4人
汇报对象： SVP & CDO
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。