以下均为公益发布推介。
企业发布需求及产业人士寻求机会联系可➕微信:eyeinno或pineapplezhang82
欧科健6月有岗位招聘发布,详情如下:
公司简介
深圳欧科健生物医药科技有限公司(简称欧科健)成立于2022年8月,是专注于大分子眼科创新疗法的生物医药科技有限公司。
欧科健总部位于广东省深圳市南山云科技大厦,并在珠海设有研发中心。
欧科健拥有一系列最新和最好的突破性眼科治疗技术产品组合,覆盖了从早期新药靶点发现,自主创新药物的开发到商业化阶段。公司期望通过提供创新药物,满足中国、亚洲乃至全球眼科疾病领域未被满足的临床需求,惠及全球眼科患者群体。
(备注:以上简介由来自公司主页)
岗位详情
高级临床项目经理(英语面试)
Key Responsibilities:
1. Full-Cycle Management of US Clinical Operations
a. Participate in the end-to-end management and implementation of the company’s innovative ophthalmic drug clinical trials in the US (from IND stage to NDA stage), including but not limited to design planning, initiation, execution, monitoring, and closure of Phase I-III clinical trials.
b. As a member of the US clinical operations team, participate in the formulation and optimization of clinical trial protocols to ensure scientific validity, compliance, and operability, specifically regarding patient enrollment criteria and endpoint setting for ophthalmic indications.
c. Serve as a core project liaison, interfacing with the US clinical team, CRO partners, clinical research sites, and Key Opinion Leaders (KOLs); participate in various US clinical operations team meetings to ensure the project advances with high quality according to timelines.
d. Conduct strict performance management of CRO teams; review key documents submitted by CROs such as trial plans, monitoring plans, and CSRs to ensure external team deliverables meet company standards and budget requirements.
2. Regulatory Filing and Compliance Support
a. Assist the Regulatory Affairs team in preparing the clinical sections of IND, NDA, and other submission materials; participate in Pre-IND and End-of-Phase meetings.
b. Collaborate closely with the Medical Department and related functions to resolve complex issues encountered in clinical trials regarding medical, regulatory, and drug supply matters.
Qualifications & Requirements:
1. Education:
a. Master’s degree or above in Medicine, Pharmacy, Biology, or related fields.
b. Background in Ophthalmology is preferred.
2. Work Experience
a. Bachelor’s degree with 10+ years, or Master’s degree with 8+ years of clinical R&D experience; including at least 3+ years of experience in US clinical trial management.
b. Deep involvement in new drug clinical trials (from start-up to patient enrollment to site close-out), familiarity with the US clinical operations ecosystem (IRB processes, Site Selection, Patient Recruitment strategies, etc.).
c. Experience in clinical R&D of new ophthalmic drugs.
d. Proven success in managing international CROs and cross-cultural teams.
3. Professional Skills:
a. Excellent English listening, speaking, reading, and writing skills; capable of using English as a working language for business negotiations; daily work communication will be primarily in English.
b. Familiar with Clinical Trial Management Systems (CTMS), EDC systems, and remote monitoring models.
4. Comprehensive Qualities:
a. Strong resilience under pressure and a result-oriented mindset; adaptable to the fast-paced work environment of a startup.
b. Excellent leadership, communication, and coordination skills, with the ability to resolve complex project crises.
工作地点:
上海
投递方式:
以上信息为第三方平台发布信息,可能存在滞后,最终以用人单位实际需求为准。
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青白视角,专注于全球眼健康创新技术产品开发及应用的专业交流合作平台。
睛英荟为青白视角旗下人气号:眼里有EYE,共创睛彩
睛英荟每日更新 1-2 家眼科企业岗位,助力行业人才与企业精准匹配。目前已有多家眼科企业直接建立联系,委托我们发布岗位人才需求,包括:
跨国公司:强生、博士伦、蔡司、爱尔康、STAAR Surgical、依视路陆逊梯卡、豪雅、齐明眼科(Ziemer)、多美等;
上市公司:昊海眼科及旗下上海亨泰视觉、河南赛美视等子公司;齐鲁制药眼科事业部;远大医药眼科创新业务中心;恒瑞医药;先锋控股;以岭药业;明月镜片等;
国内创新药械企业及外企代理公司:博视医疗、博也生物、莫廷医疗、上邦医疗、诺瞳奕目、菲特兰医疗、杰视医疗、清大视光、上海美沃、BVI 中国总代理 BVI 倍锋医疗、中景纬视、执鼎医疗、眼医眼科、贝奥新视野、3N科技、犀燃医疗、鲸鸣视控,广州卫视博、臻复医疗等。
对上述企业感兴趣的人才可直接联系我们对接企业HR及用人部门。
欢迎中国眼科领域的企业和医疗机构,如有招聘需求可以联系我们。我们会在本公众号公益发布,助您招贤纳才。也欢迎眼科产业从业者、医生朋友前来交流。无论您是想找新的职业机会,还是分享经验,睛英荟都期待与您相伴,因EYEtogether!
联系方式:@青白视角 @睛英荟 任一后台留言,或➕微信号eyeinno、微信号Pineapplezhang82,邮箱:zhangjie@eyeinno.com 联系(再次申明:纯公益,信息严格保密)