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R&D Operations

Clinical Supply Operations Team Lead, China

  • Título Clinical Supply Operations Team Lead, China
  • Função R&D Operations
  • Sub função Clinical Supply Operations
  • Categoria Senior Manager, Clinical Supply Operations (PL8)
  • Local Shanghai, China
  • Postado
  • ID obrigatória 2406194057W
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Descrição

Business Description

This people leader role is responsible for overseeing a group focused on end-to-end supply chain management of clinical supplies.  Through the team, she/he ensures supply operation strategies are developed that support the Therapeutic Areas and Clinical programs and trials to ensure on time delivery and optimal supply overage for API, DP and Packaged materials.  This position provides effective functional supervision to support J&J’s success in conducting clinical trials of the highest quality, as well as trial issue management and resolution for the assigned TA/DAS area.  This role aligns, tracks and reports out budget management at a group and compound level.

Description of the Role

•          The main responsibilities of the function holder are to

−      Provide strategic and operational leadership, manage functional and compound budget and resource allocation in the Clinical Supply Management consistent with R&D objectives and timelines in China.

•          Responsible for:

−      Acts as the clinical supply chain project and team leader for one or more compounds. Drives team problem solving and acts as a coach to team members to drive their technical and personal development. 

−      For each compound, takes leadership over the escalation and (as appropriate) resolution of critical risks and issues. Ensures there is a well-designed integrated demand and supply plan from API to Kit. Leads S&OP escalation topics with limited or no guidance.

−      Influences the clinical teams in the trial design and operational aspects thereby ensuring cost efficiency and customer satisfaction, and coordinates escalation & communication to the clinical team.

−      Manages the activities required to meet First-Patient-In date of clinical trials in China. This includes initial demand forecasting, configuration of the distribution network, IVR / RTSM specifications, kit and label design, and developing supply strategies to meet clinical plans while optimizing drug overage. Influences decisions in therapeutic areas from a clinical supply chain perspective.

−      Develops and manages the clinical supply budget for trials and programs (internal FTEs as well as OOPs, excluding API and DP)

•          Act as Clinical Supply Chain champion in collaborative efforts with external companies (e.g., due diligence efforts, clinical development partnerships).

•          Develops strong collaborations with the TAs, GCO, and DPDS and other Operational Heads to ensure customer satisfaction.

•          Represents Clinical Supply Chain for a particular compound and for various processes during GCP and GMP health authority inspections or escalations.

•          Is the sponsor and identifies sponsors or leads innovative projects to significantly improve functional and cross functional processes and tools.

•          Exemplifies and drives the use of core processes and tools in the department and the teams and serves as a mentor to others to drive adoption. Creates clarity in roles and responsibilities and holds teams strongly accountable to them.  

•          Sponsor global improvement initiatives within the Clinical Supply Chain organization and represent CSC on R&D strategic improvement projects

•          Develop strong internal collaborations and relationships with the Therapeutic Areas and Global Clinical Operations to ensure customer satisfaction. 

•         Attract and develop the best possible talent within our planning teams, through smart talent acquisition and strong training and development approaches.

Qualificações

      Critical Experiences Required

•        University/Bachelors Degree plus 12+ years related experience. Or Masters Degree plus 10+ years related experience.  Technical degree and/or experience a plus.   

•       Excellent people management and leadership skills; A proven ability to execute and get results through leading others. Proven track record of developing people to leadership roles. Experience in leading a global or multisite team is a plus.

•       Experience in leading global teams and global strategies.   

•       Ability to work in a high-pressure environment; empowers self and others to act with speed, agility, and accountability to achieve goals

•       Good knowledge and understanding of clinical supplies (overall process, operational and supply chain aspects), or equivalent experience through managing a supply chain with high demand variability, short lead times and complex product portfolio is required.

•       Strong knowledge of IVR/RTSM, planning systems and simulation tools, as well as S&OP processes are a clear asset

•       Demonstrated ability in managing a global customer base and / or network of stakeholders. 

•       Ability to lead, inspire and influence team through a period of high change 

Other

•       Budget size: N/A

•       Location: Shanghai or Beijing

•       Travel: 10-15%

•       Language requirement: Chinese, Fluent in written and spoken English

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