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Clinical Operation Director/临床运营总监
50-90万/年
人 · 硕士 · 8年及以上工作经验 · 性别不限2024/11/22发布
五险一金交通补贴通讯补贴年终奖金股票期权弹性工作定期体检

浦东新区

低价好房出租>>

哈雷路998号悦颂生命科学园

公司信息
上海达歌生物医药科技有限公司

外资(非欧美)/50-150人

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职位描述
About us:
Degron Therapeutics is a rapidly growing innovative drug discovery and development company based in Shanghai, China and San Diego, USA. The company is run by a seasoned scientific and management team with financial supports from premier venture capital firms. Its proprietary molecular glue technology platform enables discovery of novel protein degraders and their respective targets, with the goal of developing therapeutics to treat diseases with unmet medical needs. We seek a highly motivated and experienced Clinical Operation leader to join our team and help us grow the company into one of the global leaders in the targeted protein degradation space.
Duties and Responsibilities:
1.Develop and implement clinical operation strategies that align with the company's overall clinical development goals.
2.Responsible for the management and implementation of domestic and overseas clinical trial projects, including project initiation, selection and evaluation of clinical sites, investigators, and CROs, and signing clinical trial contracts with research centers, monitoring during the process.
3.Responsible for key document preparation and review (protocols, IBs, CSRs, etc).
4.Manage and control clinical trial budgets, ensuring cost-effective study execution.
5.Advance the clinical projects effectively to ensure the efficiency of the work at clinical research centers or CROs, ensuring that the quality, progress, and budget of clinical research are effectively executed within the target plan.
6.Ensure programs of studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements. Identify and mitigate operational risks associated with clinical trials.
7.Establish and maintain good relationships with CROs, investigative sites, clinical experts, and other external service providers.
8.Serve as a key communicator of clinical operations status, issues, and progress to senior management and stakeholders.
Qualifications:
1.Master’s degree in Medicine, Pharmacy, Biology, Immunology, or a related field.
2.Over 8 years clinical research experience with deep understanding of clinical drug development and clinical trials operations. Experience in oncology field is a must.
3.Proven track record of managing complex clinical trials across multiple phases.
4.In-depth knowledge of clinical research regulations, guidelines, and ICH GCP standards.
5.Strong leadership, project management, and interpersonal skills.
6.Ability to work in a fast-paced, dynamic environment and adapt to change.
7.Strategic thinker with a professional demeanor, able to navigate an ambiguous environment.
8.Excellent organization skills with a results-oriented approach.
9.Ability to work independently, to handle multiple tasks simultaneously.
10.Proficient in both written and verbal communication skills in English and Chinese.
11.Regular travel may be required to visit clinical trial sites, attend meetings, and participate in industry conferences.
Location: Shanghai, China

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