苏州招聘

Medical Director（Base Beijing/Shanghai/Suzhou）

Job Responsibilities:

1、Contribute to therapeutic area strategy within Alphamab oncology portfolio; Contribute to clinical development and registration strategy. Direct the creation of clinical development plan to translate the overall project strategy into an executable development plan;

2、Accountable for leading medical input to clinical development projects from entry into development to successful approval. Lead a tailored medical team to plan and ensure the successful completion of development projects according to rigorous scientific and regulatory standards;

3、Accountable for providing medical oversight on Alphamab clinical trials; participating in high level feasibility and project risk evaluation;

4、Accountable for generating trial concept sheet, trial protocol, CSR; accountable for medical input to key regulatory documents, i.e., IND/CTA documents, IB, and NDA documents; accountable for scientific publications;

5、Support business development activities as requested;

6、Accountable for building an efficient and talented medical group; foster positive team culture and working environment; mentor and develop medical employees; streamline medical procedure, key quality indicator and key performance indicator;

7、Control medical function budget in line with corporate financial goal.

Requirements:

1、Medical doctorate or equivalent degree required. Advanced knowledge and clinical training in a medical area (for example internal medicine or subspecialty) required. Medical practice experience preferred；

2、At least 15 years of clinical research or drug development experience; at least 10 years relevant experience in pharmaceutical industry;

3、Advanced knowledge in oncology;

4、Thorough knowledge of GCP, clinical trial design, statistical analysis methodology and clinical/regulatory development process;

5、Knowledge of applicable NMPA, FDA and other regulatory agencies, regulations and guidelines;

6、Strong influencing, initiative and problem solving skills;

7、Leadership and people management skills.

康宁杰瑞生物制药是一家专注于研发、生产和商业化创新抗肿瘤生物大分子药物的生物制药公司。2019年12月12日，公司在香港联合交易所主板上市，股票代码：9966。
康宁杰瑞生物制药在双特异性抗体及蛋白质工程方面创建了全面整合的研发和制造平台。公司高度差异化的产品管线由包括具有自主知识产权的八种肿瘤单抗和双抗候选药物以及一种Covid-19的多功能抗体组成，四个产品在中国、美国、日本处于Ⅰ-Ⅲ期临床试验和上市前阶段。公司拥有异二聚体及混合抗体等多个具有自主知识产权的技术平台，和符合中国、美国和欧盟cGMP标准的大规模生产能力，并且通过包括欧盟QP在内多次审计的完整的质量体系。公司致力于建设国际领先的，多维度的药物开发和产业化平台，聚焦多功能生物大分子新药，惠及中国和全球的患者。