Major Responsibilities and Duties:

• Leads the clinical development for the assigned compounds or products.
• Deeply understands I-Mab’s clinical development strategy and plan. Responsible for I-Mab’s clinical development strategy and CDP in line with TPP and I-Mab strategies.
• Leads cross-functional team to develop and drive clinical development strategy and plan. Keep the China clinical development plan updated.
• Propose clinical study design and develop clinical study protocol based on the clinical development plan.
• Be accountable for all clinical deliverables (e.g. protocol, investigator meeting training, medical monitor, medical review, clinical study reports and submission summary / HA response document, contribute to HA interactions, such as CDE panel meeting and responsible for the clinical questions, etc.)) if applicable.
• Ensure the medical and scientific sound and fully meet HA requirements for the compound registration. Provide physician guidance and expertise on patient care to clinical studies (including medical monitor, etc.) if necessary.
• Provide clinical input for commercial assessment and portfolio prioritization. Medical support to cross function, such as RA, STATs, Operation, Discovery etc.
• Communicate and cooperate with internal and external customers. Develop and maintain close academic relationship and collaboration with KOLs and other critical stakeholders. Undertake tasks as agreed with the Head of Immunology & Early development.
• Contacts of key internal and external stakeholders, such as cross-function teams in R&D(e.g. RA, Statistics, Discovery, PMO etc.), global TA person in charge, external KOL, specialized medical association and other key stake holders.

Qualifications:

• MD. is mandatory; MSc. or PhD is an asset. Medical practitioner’s qualification certification holder.
• Thoroughly understand and command knowledge of product and relevant diseases.
• Solid knowledge of clinical development process and HA (especially CFDA) requirements.
• Thoroughly understand and command GCP.
• Thoroughly understand and command HCC.
• At least 3-year clinical practice in relevant therapeutic area and 3-year working experience in pharmaceutical industry, especially clinical development is preferred.
• Strategic and creative thinking capabilities; keen clinical development insight; excellent communication and team collaboration skills; leadership capabilities.
• Excellent English abilities of listening, speaking, reading and writing; same level of CET-6.

上班地址：浦东新区上科路88号豪威科技园区西塔8楼802室