上海招聘

Major Responsibilities and
Duties:

1. Leads the clinical development for the assigned compounds or products.
2. 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.
3. Leads cross-functional team to develop and drive clinical development strategy and plan. Keep the China clinical development plan updated.
4. Propose clinical study design and develop clinical study protocol based on the clinical development plan.
5. 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.
6. 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.
7. Provide clinical input for commercial assessment and portfolio prioritization. Medical support to cross function, such as RA, STATs, Operation, Discovery etc.
8. 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.
9. 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:

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

天境生物科技(上海)有限公司
天境生物由臧敬五博士领衔的创新药资深研发团队创建，是一家聚焦在肿瘤免疫和自身免疫疾病精准医疗领域的新药研发生物医药科技公司。
公司的核心竞争力在于早期研发、靶点发现和验证、工艺开发&临床前评价、质量科学&质量管理、早期临床研究的能力（包括临床一期和临床二期）。团队在创新药物靶点生物学、创新抗体药物分子结构研发以及创新药物的转化医学及临床研究方面的优势为公司建立一条具有国际竞争力的项目管线创造了基础。公司目前创新药管线含12个在研创新抗体药物项目。领先的创新药项目将在2017年3月申报临床研究并在台湾, 韩国及中国启动临床研究, 其它项目均已进入细胞株或工艺开发阶段。
公司从成立以来已经建立了广泛深入的国际合作, 如与瑞士FERRING公司合作独家引进开发Olamkicept。公司自主研发的全球创新药项目将在2018年进入中国及美国临床研究申报环节并计划在两地启动一期临床研究。