药品研发项目经理

Job Description
Director ofpreclinical development
The Company
HHAJ Biotech Inc. Ltd. isan early stage biotech company committe********bringing novel therapeutics to hepatitis B an******** patients. Thecompany focuses on high value therapeutics addressing unmet medicalneeds in large markets. HHAJ is a spin-off company with roots in theNational Institute of Biological Sciences (Beijing).

The position
HHAJ is seeking a highly skille******** motivatedDirector of preclinicaldevelopment to leadan******** preclinical development activities forantibody therapeutics. The scope of Preclinical Development spans frompreclinical development through Phase 1 clinical studies.The candidateshoul******** a strong biomedical backgroun******** experience in INDenabling programs of antibody or other b******** ideally with a proventrack recor******** successfully bringing pipeline products from benchthrough Phase 1 development.

The Responsibilities
 Oversight an******** of nonclinical studies.
 Selection an******** of Preclinical studies to Contract ResearchOrganizations (CROs).
 Coordinates activities with CROs an******** collaborators forPreclinical Development in the areas of CMC, tox******** pharmacology,pharmacokinetics as well as animal models.
 Prepares project timelines an******** internal an******** studies toensure they are performe******** a ******** timely an******** manner.
 Critically review an******** of studies ******** analysis an********with HHAJ’s teams or with the CROs an******** experts.
 Maintain up to date knowledge of regulatory agencynonclinical/clinical pharmacology an******** regulation********
 Prepare reports, regulatory documents an********.
 Ensures compliance with GLP, GMP, an******** guidelines.

Qualifications an****************
 PhD or MS with 5+ years experience in a biomedical or closelyrelate********
 3-5+ years biotec******** experience for antibody drug in anindustrial setting.
 Strong lea******** organ******** verbal an******** communicationskills
 Strong critical thinking an******** skills.
 Demonstrate******** with nonclinical study design an******** forantibody/protein therapeutics.
 Deep understanding of the discovery an******** drug developmentprocess
 Previous experience an******** with choos******** negot********an******** relations with contractors, including CROs is a plus.

临床前研发项目经理：

工作职责：
1、负责公司研发项目管理；
2、参与制定公司发展战略；
3、负责新产品研发项目的立项调研、实施计划、目标与预算，组织、落实与质量控制。
4、负责对外与CRO公司的沟通、合同签订、项目实施进度监督及结果验收总结等；
3、药品申报资料的审核；
4、医药行业相关法律法规信息收集；
6、国内外前沿技术信息收集。

任职要求：
1、博士或硕士+5年以上生物医学或相关专业；
2、具有抗体药物临床前开发3-5年及以上工作经验，熟悉毒理、药效、药代学，CMC等
2、熟悉国内、外生物药品注册法规和研发技术要求。
3、生物制药 药品研发项目管理3-5年及以上工作经验；
3、有较强的沟通、组织协调能力，及解决问题的能力；
4、有一定的英文基础和交流能力。