Sr. Director of CMC-IND/CTA Program Management
上海药明康德新药开发有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-04-15
- 工作地点:上海
- 招聘人数:1
- 职位月薪:面议
- 职位类别:生物工程/生物制药 药品注册
职位描述
Qualifications:
PhD or equivalence in biomedical/pharmaceutical science with at least 10 years experience in pharmaceutical industry or contract research organization in project management. Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D from discovery to clinical development and regulatory registration; Familiar with relevant FDA, ICH and EMA/OECD guidelines/regulation and tracking record on strategic planning and execution of IND/CTA programs; Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system; Excellent written and oral communication skills.
Responsibilities:
The Project Director and Head of CMC is responsible for all aspects of a specific integrated service or IND/CTA-enabling program conducting at WuxiAppTec and able to define the project’s objectives and oversee quality control throughout its life cycle to its NDA/BLA approval. He/she will service as an expert for all CMC-related discipline within Product Development Services and Partnership Business Unit.
This position requires direct communications with Sponsors and ability to work across functional units internally to plan, execute, and complete testing programs within scope and required quality according to Sponsor’s requirements and planned timeline; He/she will define and manage project resource needs and establish succession plans and responsible for monitoring team performance and facilitate adjustments when necessary to ensure goal attainment. He/she will initiate issue-oriented agendas to facilitate effective team meeting discussion and be able to summarize and provide guidance on follow-up strategies to ensure timely resolution of outstanding items. He/She will contribute to proposal strategy, development, costing, and bid defense for assigned business development opportunities and be able to proactively identify out of scope activities, risks and manage client expectations & serve as key client contact for assigned projects.
PhD or equivalence in biomedical/pharmaceutical science with at least 10 years experience in pharmaceutical industry or contract research organization in project management. Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D from discovery to clinical development and regulatory registration; Familiar with relevant FDA, ICH and EMA/OECD guidelines/regulation and tracking record on strategic planning and execution of IND/CTA programs; Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system; Excellent written and oral communication skills.
Responsibilities:
The Project Director and Head of CMC is responsible for all aspects of a specific integrated service or IND/CTA-enabling program conducting at WuxiAppTec and able to define the project’s objectives and oversee quality control throughout its life cycle to its NDA/BLA approval. He/she will service as an expert for all CMC-related discipline within Product Development Services and Partnership Business Unit.
This position requires direct communications with Sponsors and ability to work across functional units internally to plan, execute, and complete testing programs within scope and required quality according to Sponsor’s requirements and planned timeline; He/she will define and manage project resource needs and establish succession plans and responsible for monitoring team performance and facilitate adjustments when necessary to ensure goal attainment. He/she will initiate issue-oriented agendas to facilitate effective team meeting discussion and be able to summarize and provide guidance on follow-up strategies to ensure timely resolution of outstanding items. He/She will contribute to proposal strategy, development, costing, and bid defense for assigned business development opportunities and be able to proactively identify out of scope activities, risks and manage client expectations & serve as key client contact for assigned projects.
公司介绍
药明康德是国际领先的开放式能力与技术平台公司,为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任,以客户为中心的宗旨,药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等,正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目,致力于将最新和***的医药和健康产品带给全球病患,实现“让天下没有难做的药,难治的病”的梦想。
联系方式
- Email:zhuyun@wuxiapptec.com
- 公司地址:江北新区华康路122号南京生物医药谷加速器四期07栋
- 电话:15738851478