Responsibilities:
1. Lead medical input clinical development strategy portfolio planning, ensuring alignment with corporate objectives unmet medical needs.
2. Provide medical leadership in clinical study design, endpoint selection, statistical considerations in collaboration with cross-functional teams (Biostatistics, Regulatory, CO, PV, etc.) to generate high-quality, regulatory-compliant protocols.
3. Author, review, maintain core clinical trial documents (IB, Protocol, ICF, CSR) in compliance with ICH-GCP, regulatory guidelines, company SOPs.
4. Serve as Medical Monitfassigned studies: provide medical oversight of eligibility assessment, subject safety (SAE/AE review), protocol deviation management; ensure risk-benefit profile remains favorable.
5. Support medical activities across the product lifecycle (Phase I-IV, post-marketing studies); contribute to regulatory submissions (IND/NDA/BLA).
6. Lead and/oversee scientific publications, abstracts, presentations at majcongresses.
7. Establish maintain long-term strategic relationships with KOLs.
Qualifications:
1. Master above degree in clinical medicine, pharmacology related area, with Ph.D. preferred.
2. Minimum 3-5 years of experience of clinical research/clinical development is highly desirable, including medical monitoring, writing medical support.
3. Have a strong leadership, excellent writtenal communication skills.
4. Strong capability of work prioritization deliver results with parallel multiple tasks.
5. Therapeutic expertise in Respiratory diseases (e.g., asthma, COPD) is highly preferred.
6. Experience of working in MNCs is preferred.
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