Key Responsibilities

• Develop the Target Clinical Profile (TCP) and establish clinical development strategies

• Lead the development and review Clinical Study Reports (CSR) and Common Technical Documents (CTD)

• Oversee the execution and monitoring of clinical trials

• Manage relationships with Key Opinion Leaders (KOLs)

Major Role

• Oversee the development of the TCP and the establishment of clinical development strategies

• Lead the authorship and review of Clinical Study Reports (CSR) and Common Technical Documents (CTD)

• Manage clinical trial execution and monitoring

• Address scientific queries arising during clinical trial planning and execution

• Interpret clinical trial data and perform periodic monitoring

• Support the development of clinical trial design and review clinical databases/data analysis plans (e.g., CRF, SAP)

Qualifications

[Requirement]

• Ph.D. in Life Sciences (e.g., Medicine, Pharmacy, Nursing, or related fields)

• 7+ years of experience in clinical development or a related industry

• Excellent proficiency in English

• Experience in early drug development (Discovery/Pre-clinical)

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