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PROJECT DIRECTOR, INTEGRATED SERVICES & IND ENABLING Qualifications: PhD or equivalence in biomedical science with at least 10 years experience in pharmaceutical industry or contract research organization in project management. Experience in managing drug development projects with proven experience of working effectively in multi- discipline teams; Demonstrated successful leadership, planning and organizational skills with strong knowledge in pharmaceutical R&D from discovery to clinical development and regulatory registration; Familiarity with relevant FDA, SFDA, ICH and EMA/OECD guidelines/regulation and track record on strategic planning and execution of IND/CTA programs in preparation and submission; Experiences in certain functional areas such as DMPK, CMC, Toxicology and/or Pharmacology is a plus; Excellent written and oral communication skills. Responsibilities: The Project Director is responsible for all aspects of a specific cross BU integrated project or IND/CTA-enabling program conducting at WuxiAppTec. This includes but not limited to Integrated Project Strategy Planning and Options Development; Optimizing Operational Efficiency; Project Risk Analysis and Management; Communication Management; and oversee quality control throughout the project life cycle. 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 project development 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, and manage client expectations & serve as key client contact for assigned projects. WuXi AppTec welcomes overseas talents join us. We offer you a highly competitive compensation and full benefits package along with an exciting world-class work environment. For more information, please visit our website: http://www.wuxiapptec.com/ . WuXi AppTec Co., Ltd. is a NYSE listed public company based in Shanghai, China. We offer global pharmaceutical/biopharmaceutical companies diverse outsourcing services in combinatorial, medicinal, synthetic chemistry and manufacturing of API s and finished drug products for preclinical and clinical trials. Our clients include over 80 leading global pharmaceutical and biotech companies in the U.S., Europe and Japan. |
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