Note: Applicants must have permission to work in Japan
The Supply Chain Lead (SCL) is the Global Clinical Supply Chain (GCS) key point of contact for RU/BU customers., They are responsible for liaising with either Global Product Development (GPD) Study Team Managers or Medical Affairs and Clinical colleagues when coordinating operational activities within GCS and our partners (i.e. Quality, Analytical, Small and Large Molecule Pharm Sci, and Regulatory).
The SCL is expected to translate early and late development product strategies into effective Supply Chain (SC) strategies for the duration of each clinical trial or compassionate program. The SC strategy is inclusive of scope, time, cost and risk which balance the needs of the customer and SC. The SCL maintains clinical supply availability to maintain alignment with customer milestones and keep patients on drug. The SCL will be assigned at a program, asset or protocol level to provide clinical team members with broad consults on all aspects of clinical drug supply. SCL will need to liaise with other SCLs (lead SCLs assigned at a program level) at a protocol level to understand drug supply sourcing strategies, including local strategies (country specific requirements/needs).
Through a solid understanding of clinical study design and drug supply risks, the SCL will ensue supply strategies are executed and maintained for the duration of the study. The SCL in conjunction with the Lead SCL may need to adopt varying strategies during a study, depending on clinical development changes (i.e. visit changes, randomization arms added and/or dropped, etc.) that are required for the business.
Support of compassionate use and/or grant studies clinical supply may be required, depending on asset need.
Development and operational execution of investigational product supply strategies for early and late stage clinical studies intended for regulatory approvals of new products and for new indications or line extensions of currently approved products.
Designing and/or assisting the Lead SCL the appropriate clinical supply strategy, balancing the supply chain risk and cost in alignment with the compassionate program or Clinical protocol, the BU/RU budget for clinical supplies and ensuring clinical supply delivery and patient focus/continuity.
Act as a subject matter expert and links key resources to provide all information regarding the global use of investigational material in clinical studies.
Forecasts clinical supplies for protocols to maintain a robust and sustainable supply for new and ongoing clinical studies in conjunction with Lead SCL, when appropriate
Is an active participant on the Clinical Supply Team, when feasible and interacts with a network of internal and external partners to ensure MedSci meets the customer expectations and supports the key Clinical milestones for study support and patient resupply.
Provides effective communication to team members across GCS functional lines and stakeholders to ensure understanding of studies and clinical supply status.
- B.S. degree within a scientific discipline with 2-5 years of Development Operations, Pharmaceutical Sciences, Project Management or Supply Chain experience or Pharmacy
- Desirable professional certification in project management.
- Biopharmaceutical development and/or clinical development.
- Supply chain technology
- Management of investigational products for a clinical research unit or investigational drug pharmacy or Supply Chain Interaction with multi-disciplinary teams that includes project management, negotiation, issue resolution, conflict management, and process improvement.
- Proven ability to effectively develop, communicate, and execute project plans with multiple stakeholders.
- Strong organizational skills and ability to prioritize multiple projects and meet targeted deliverables and deadlines; strong planning and multi-tasking skills.
- Ability to adapt to changing situations and work well under pressure.
- Technical proficiency, including skills in use of common desktop tools (MS Word, MS Excel, MS Project, Visio); Office365 and SharePoint; tools for reporting (Spotfire); and systems for document management, communication, and learning management.
- Strong verbal and written communication skills, with preference given to bi-lingual or tri-lingual capabilities in Japanese, English and Chinese (Mandarin)