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Medical Director (Clinical Development)
60-110万/年
人 · 硕士 · 6年及以上工作经验 · 性别不限2025/01/24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

该公司所有职位
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 high unmet medical needs. We seek a highly motivated and experienced Clinical Research Physician to lead the clinical development of our novel molecular glue drugs

Duties and Responsibilities:
Medical Lead of Clinical Development Teams and Study Physician/Medical Director for early phase clinical studies. Activities include, but are not limited to, clinical development plan, clinical study design and protocol preparation, additional study or investigator documentation, contributions to data analysis plans, ongoing data interpretation, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.

Key responsibilities:
1. Lead or participate in the development of the company's clinical research strategy and portfolio
2. Manages the clinical development component(s) in the preparation/review of regulatory documents, including urgent information requests, investigator brochures, clinical study reports
3. Lead clinical trial protocol design, clinical study reports and response to health authority inquiries
4. Provides scientific and clinical guidance to cross-functional teams and colleagues to meet early development project deliverables and timelines
5. Provides ongoing medical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
6. Conduct analysis of ongoing data for internal analysis and review and ensures appropriate data cleaning and integrity
7. Review of data listings, summary tables, study results
8. Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings
9. Develops manuscripts for publication in peer-reviewed journals
10. Presents scientific information to clinical study investigator at appropriate meetings
11. Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as company SOPs
12. Provides clinical guidance to Research (including Biology, Toxicology), Clinical Operations, Biomarkers, Clinical Pharmacology, Biometrics, Patient Safety, Regulatory, and Project Management staff
13. Frequent, direct contact with study sites and investigators
14. Supports or leads regular safety calls and safety review committee meetings
15. Identify and map KOLs, investigators and research centers within the relevant therapy areas, and engage with them regularly to gather valuable medical insights

Qualifications:
1. MD or equivalent (eg. Bachelor of Medicine from 5-6 year Medical Schools) with 5+ years' clinical drug development experience in the biopharma industry environment
2. Strong scientific and translational abilities as demonstrated through past experience and/or academic research as evidenced by applying novel drug mechanism of action to address relevant human pathology
3. Successful records of independently lead early clinical development from *** in human (FIH) through proof of concept (POC) for one or more projects in biopharma industry
4. Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations
5. Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials
6. Experience in oncology drug development preferred, especially early clinical development
7. Significant experience working on, with and leading cross-functional project/program teams
8. Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership
9. Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality
10. Excellent scientific writing and oral communication skills
11. Proficient in both written and verbal communication skills in English and Chinese.
12. Ability to travel domestically and internationally to scientific, regulatory, investigator, and other meetings (~20-30% travel expected)

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