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	§ Qualified Medical Doctor (MD) who has completed an accredited residency program or equivalent § Registered oncologist is preferred.
Work experience	§ More than 6 years’ experience with substantial knowledge of drug development and extensive clinical research experience in well-known international / domestic pharma. § Have designed and implemented early and/or late stage of oncology clinical trials.
Capacity requirements	§ Excellent knowledge of all aspects of the clinical trial process including planning, execution and reporting/publication of results § Familiar with GCP and clinical trial regulations, 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 § Strong communication, coordination and issue solving ability

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
Work experience	§ 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

往期文章：

我的目标

1）海外生物医药人才的寻访

2）海外生物医药项目融资和引进

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