我的客户成立于2015年，是一家专注于自身免疫及过敏性疾病生物疗法的临床后期阶段生物医药企业，拥有完全自主研发的药物管线及成熟的商业级规模的内部生产能力。已拥有及申报国内外专利90余项，亦被江苏省生产力促进中心认定为潜在独角兽企业。


工作内容

* Leads the effort of medical team for clinical development, reports to CEO, Global Clinical Development
* Responsible for creating Clinical Development Plan for innovative biologics in oncology and autoimmune disease areas from Phase I (FiH) trial to Phase III registrational trials. Candidate for this position needs to combine his or her medical knowledge with the expertise of colleagues in a wide range of other disciplines (e.g., Biology, Translational Research, Imaging, Clinical Pharmacology, Biostatistics) to optimize the clinical development plan
* Responsible for the accuracy and integrity of clinical protocol, investigational brochure, ICF, and medical monitoring plan.
* Responsible for establishing working relationship with Investigators, Clinical sites, as well as regulatory authorities.
* Responsible for anticipating and addressing various medical problems that may arising from clinical trials and from health authority, including:
* Provides strategic medical guidance for the development of new biologics that are in late phase of preclinical development, when needed.


福利待遇

专注于自身免疫及过敏性疾病治疗方案，全面布局皮肤、风湿、呼吸及消化四大疾病领域；

成熟的商业级规模生产能力，确保以稳定及成本可控的方式供应产品；
富有远见且拥有丰富行业经验和成功创业经验的管理团队。
完善的薪资进阶方案，富有竞争力的薪酬体系，丰富的福利政策


理想的求职者

* MD degree required, Oncology and/or Autoimmunology specialty is preferred

* Fluent English - Oral and written

* Needs extensive, successful pharma/biotech industry experience in oncology and/or autoimmune clinical trials;
* Proven ability to formulate succinct clinical development plan, to develop clinical protocol, investigational brochure;
* Proven ability to effectively perform various medical monitoring activities in all phases of clinical trials
* Proven capability to logically analyze and interpret efficacy and safety data relating to oncology and/or autoimmune diseases;
* Demonstrated capability of interpreting preclinical data in oncology and immunology (molecular biology, pharmacology, pharmacokinetics, and toxicology);
* Working knowledge of the application of PK/PD and biostatistics to clinical development and clinical trials;
* Knowledge of GCP and world-wide regulatory requirements relating to clinical trials and oncology;
* Excellent medical/scientific writing skills;
* Effective written and oral communication skills;
* Excellent personal ethical integrity and a commitment to improving the outcomes for patients
By submitting an application for this role, you agree to Michael Page collecting your personal data (possibly sensitive data), sharing it with third parties and where applicable exporting it to parties outside of mainland China.
若您提交针对该职位的求职申请，您同意米高蒲志收集您的个人数据（可能是敏感信息），并将您的个人数据传输给第三方，且在有必要的情况下传输至中国大陆境外的接收方。

其他信息


所属部门：Pharmaceuticals