Manager/Sr. Manager Clinical Supply Chain
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective, and lower-risk drug development in international markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally.
For more information, please visit www.huyabio.com
HUYA is seeking a self-motivated individual to take a management position in a fast-paced environment as a Manager/Senior Manager Clinical Supply Chain reporting to the Director, Clinical Supply Chain. In this role, you will work within the global CMC and Supply Chain function, supporting clinical operations throughout the clinical study supply lifecycle.
You will coordinate the uninterrupted supply of clinical trial materials (CTM) to clinical sites ensuring study timelines are met. This role will be responsible for managing the outsourced packaging, labeling and distribution of CTM, including the development of specifications for an Interactive Response Technology system (IRT) and overall inventory management at Depot and sites.
Your goal will be to make sure that appropriate clinical supplies are always available to support global clinical studies for a wide range of study types.
Primary Duties and Responsibilities
- Create CTM demand forecast and manage supply plans which enable aggressive study start dates and uninterrupted supply.
- Manages CTM inventory at study depot(s) and site(s)
- Manages outsourced packaging, labeling and distribution of CTM supporting multi-center, multi-national global clinical trials.
- Manages vendor documentation required for movement of investigational product (IP) domestically and internationally.
- Oversees IRT/IWRS/IXRS system development (URS and UAT) and inventory management
- Reviews protocols, batch records, specifications, reports, SOPs, etc. in collaboration with QA to ensure that all IP to be dosed in humans is fit for purpose and documented properly
- Addresses temperature excursions that occur during transport and/or site storage
- Reconciles returns and coordinated destruction of CTM
- Establish and maintain genealogy process for all IMP from API through to packaged finished goods.
- Manage global clinical supply logistics and distribution activities for all company products.
- Create and manage study drug forecasting across all Clinical IMP.
- Work with Quality Assurance to review and resolve all shipment related issues (i.e. damage, temperature excursions, etc.)
- Trigger and track shipments of Investigational Medicinal Products (IMPs) from central depot(s) to regional hubs and local depots, globally
- Generate status reports and communicate to department head as required.
- Manage batch record review and batch release of labeling activities
- Liaising with IRT vendors to create supply algorithms and review the UAT/URS of the IXRS in coordination with the IRT vendor.
- Design, configure and review IWRS/IVRS system(s) for drug supply management, accountability, and enrollment of global clinical studies.
- Trigger and track shipments of (IMPs) from central depot(s) to regional hubs and local depots, globally
- Develop, maintain and execute an optimal resupply strategy with proactive planning, lead-time, and replenishment quantities to ensure continuity of clinical supplies, including expiry management.
- Manage drug supply in coordination with Supply Chain for complex international Phase II and III trials, including management of packaging, labeling, and distribution vendors.
Job Qualifications and Requirements
- Excellent planning and communication skills and the ability to successfully organize and manage your time effectively.
- Excellent verbal and written communication skills.
- Ability to build strong working relationships and to collaborate and influence colleagues and stakeholders.
- Extensive global experience gained in a senior clinical supply position.
- Strong understanding of Clinical Protocols and Study designs.
- Working knowledge of ICH guidelines, GCP's, 21CFR and Annex 13 requirements.
- Good knowledge of forecasting.
- The willingness to travel globally as required.
Education and Experience
- BSc or MSc degree in a life science subject
- Minimum of 5 years’ experience in a sponsor or CRO environment supporting global phase II to III clinical trial programs
The position is full‐time, and the candidate must be within commuting distance to HUYABIO’s Del Mar, CA headquarters.