成都招聘

Duties and Responsibilities:

- Manage and facilitate development/review of all critical clinical study documents, including clinical protocols, informed consent forms, or other study-related clinical documents (e.g. Study Plans, Case Report Forms, Source Documents, Monitoring Plans, Data Management Plan, Project Management Plan, etc.)

- Provide clinical operations oversight in the identification, evaluation, and selection of CROs, outside vendors (e.g., central labs, central IRB, IVRS, etc.), and investigative sites.

- Supervise clinical team to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH GCP, and Hinova SOPs.

- Manage, coordinate, provide ongoing assessment, and communication with other Hinova departments (e.g., Regulatory, CMC, and Project Management) and external vendors (CRO, consultants, etc.) to ensure study objectives/timelines are accomplished.

- Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.

- Participate in forecasting study expenditures and resourcing needs.

- Ensure internal clinical team and vendors manage and monitor study-related budget and expenses to meet forecast.

- Provide timely communication of any variances in budget forecast to the Clinical Department Head.

- Establish communication flow with CRO and investigative sites to maximize compliance with study protocol.

- Manage recruitment efforts and activities to meet study enrollment goals and timelines.

Education and Experience:

- Proficient in English if English is not the native language.

- Minimum BA/BS in life sciences or equivalent college program, and/or commensurate experience in the clinical research industry; Master’s Degree preferred.

- 5+ years of experience in the pharmaceutical/biotechnology industry.

- 5+ years demonstrated work experience of successfully managing clinical trials within the pharmaceutical industry, including CRO and contract vendor management, preferably in an oncology therapeutic area.

- Experience in management of international or global clinical trials is highly preferred.

- Strong project management skills.

- Experience in clinical site monitoring as a CRA.

- Experience in development of essential clinical study documents, including informed consent, monitoring plans, source documents, Case Report Forms (CRFs), study recruitment plans, etc.

- Experience in protocol development/writing.

- Both working and theoretical knowledge of ICH GCP, clinical trials management with exposure to various phases of drug/trial development life cycle preferred (e.g., Phase I- IV, start-up through close-out), scientific methods, research design, regulatory compliance, and clinical data management.

- Demonstrated strengths in planning, organizational, analytical skills, oral and written communication, time management, conflict management, problem solving, and attention to detail.

- Ability to supervise, direct and lead team members as well as interact with other internal staff.

- Strong planning and organizational skills with ability to multi-task and plan activities as they relate to the management of clinical trials, ability to problem-solve.

- Excellent written and verbal communication skills and strong interpersonal skills necessary to interface with physicians, outside vendors, consultants, and team members.

- Possess advanced computer skills (Microsoft applications, spreadsheets, etc.

- Ability to work effectively within a team matrix as well as independently.

- Financial management skills as applicable to oversee project expenditures.

海创药业有限公司是国家高新技术企业，总部坐落于中国成都，在美国、澳大利亚等地设有分支机构，面向全球市场开展新药研究及产业化。公司依托全球领先的氘代、PROTAC、高端制剂等技术平台，开发具有广阔市场潜力的重大新药品种，目前有包括治疗前列腺肿瘤、乳腺肿瘤、痛风等疾病的多个创新药物处于临床和临床前不同研究阶段。已建立了包括药物化学、生物筛选、工艺研究、质量研究、注册申报、临床研究、生产外包等完整药物研发和产业化体系。

海创现有产品管线中，HC-1119（治疗去势抵抗性前列腺癌新药）已经启动全球多中心临床III期试验；HP501（治疗痛风和高尿酸血症新药）已获得NMPA颁发的《临床试验通知书》，正在四川大学华西医院GCP中心开展临床I期试验。公司已申请 PCT和中国发明专利超过100项，获得中国、美国、日本、欧洲等国家和地区专利授权30项。

海创药业组建了由来自全球知名世界500强企业的十余位海归专家组成的核心管理团队，并引进了包括诺贝尔奖获得者、美国两院院士、中国科学院院士以及临床医生等组成的科学顾问委员会。公司荣膺国务院重点华侨华人创业团队、四川省顶尖创业团队、成都市顶尖创业团队等荣誉。