美国招聘医学(执行)总监,临床运营总监和注册经理(homebase)
公司背景:
通过利用生物医药行业的药物研究平台,以提供创新药物“best-in-class”为主营业务,同时建立自主研发管线,为癌症治疗领域提供新方案。已完成数千万美元的C轮融资
汇报:CMO
下属:无 (管理CRO团队)
地点:美国当地,在家办公
Position: | Medical (Executive or Senior) Director |
Essential Responsibilities | |
§ Establish and maintain good relationship with professional societies and KOLs/ PIs in academic fields related to company’s products, and effectively communicate with external relevant medical experts (including the experts from CDE etc) § Design clinical development plan, write / review medical documents such as study protocol, clinical study reports, and other medical related documents § Review / monitor clinical study data during the trial execution, write / review medical monitor report § Review laboratory values, adverse events, coding dictionaries and data tables, listings and figures as needed § Assist cross-functional team in pre-clinical R&D of new drugs and other affairs such as registration in FDA and CFDA § Analyze, introduce and interpret clinical research and published data , and cooperate with functional depts of PV, IP, CO , DM and Statistics § Prepare and deliver data such as summaries, briefing, oral presentation etc. on both domestic and / or international conference § Provide medical support and professional guidance for clinical trials, such as protocol training, disease knowledge training, participating project meetings, answering medical queries. § Communicate with project members and other department personnel in a timely manner. § Other tasks assigned by the supervisors | |
Qualifications/Requirements | |
Education level | |
Work experience | |
Capacity requirements |
Position: | Clinical Project Director |
Essential Responsibilities |
§ Prepare and define the project scope and strategy of work, including costs, budgets and deliverables § Participate the selection of external service providers (such as CRO, EDC vendor etc.) § Oversight, monitor and track study deliverables with each milestone according to the plan § Establish project governance, manage the issues and ensure the risks under the control § Contribute to the preparation of study documentations such as protocols, amendments, IB, ICF, CRF, CSR etc § Responsible for tracking, distribution and filing of clinical trial documents/information with quality review for accuracy and completeness § Responsible for the clinical trial meets ICH – GCP guidelines, local regulatory requirements, clinical trial plans and relevant SOP protocol § Maintain good communications and relationships with (sub-)investigators and/or CRO partners, including but not limited to CRC, CRA, PM or DM if applicable § Support and coordinate the clinical trial application for amendment and progress report to ethics committee and regulatory authority, if applicable, and obtain approval within required timeline § Effectively manage the contract, payment and the trial execution on study sites § Organizes appropriate relevant trainings (to external vendors and /or team members) and project teleconferences as applicable § Communicate with superiors, project members and other department personnel in a timely manner. |
Qualifications/Requirements | |
§ More than 10 years of clinical research experience in pharmaceutical companies or CRO § At least 5 years’ experience with clinical trials management | |
Capacity requirements | § Excellent knowledge and experience of all aspects of the clinical trial process including planning, execution and reporting/publication of results § Familiar with GCP and clinical trial regulations, clinical trial design, study process and statistical analysis § Proven communication skills, both written and verbal, at all levels of an organization § Must be willing to travel as required § Honesty, Proactive & Self-initiative, responsible with strong team spirit and global mindset § Able to drive action, partner and be proactive in engaging all stakeholders, regardless of reporting line |
新药注册经理或总监
岗位职责:
1、全面负责公司药品国内外注册申报工作,跟踪在研项目进度,检查和审核药品注册申报资料,确保资料的真实性、完整性与合规性。
2、在新药临床前和临床研究阶段,及时与CFDA及相关审评机构进行沟通,及时跟踪更新国内外行业动态、法规变化及相关技术要求,为公司的决策及制剂、新药研发、生产等提供有关的药政事务意见。
3、负责新药注册申报资料撰写和审核,保证在规定时间内完成申报,配合药品监管部门办理相关手续,使注册申请得以顺利批准。
4、负责药监当局inspection的协调,完成注册过程沟通、跟进及年度报告的更新。
5、了解FDA、CFDA法规差异及各自优先审评等政策,能设计新药申报策略。
6、负责建立与CDE、新药审评专家的良好工作关系。
任职资历:
1、具有医学、药学、生物等相关专业背景本科学历及以上。
2、具有5年以上工作经验,其中新药注册申报5年以上工作经验,具有工艺、制剂开发、质量控制、毒理药理等相关临床前研究经验者优先。
3、熟悉新药注册法规、制度和申报流程;熟悉ICH相关指导原则。
4、能撰写和审核申报材料,有超过一项的一类新药的申报和注册经验。
5、热爱注册工作,有较强的责任感和团队合作精神。
工作地点:天津/北京/上海/美国