Manager / Sr. Manager Clinical Supplies
HUYA is seeking a self-motivated individual to take a management position in a fast-paced environment as a Manager/Senior Manager Clinical Supplies. In this role, you will work within the global CMC and Manufacturing Operations Supply Chain function, supporting clinical operations throughout the clinical study supply lifecycle. You will be the single point of contact, liaising between clinical functions, supply chain and manufacturing. 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. You will also work very closely with HUYA’s quality, regulatory, and research and development teams.
Primary Duties and Responsibilities
- Manage drug supply in coordination with Supply Chain for complex international Phase II and III trials, including management of packaging, labeling, and distribution vendors.
- Establish and maintain genealogy process for all IMP from API through to packaged finished goods.
- Build and maintain systems and procedures to achieve production and supply chain objectives associated with clinical supplies.
- Manage global manufacturing and clinical supply logistics and distribution activities for all company products.
- Monitor and react to inventory challenges at clinical sites to ensure product availability to patients
- Create and manage study drug forecasting across all Clinical IMP. Adjusting resupply strategies as required.
- Collaborate with Clinical Operations, Quality, Regulatory, and CROs in developing supply requirements.
- Work with Quality Assurance to review and resolve all shipment related issues (i.e. damage, temperature excursions, etc.)
- Lead and manage the IMP returns process, ensuring vendor compliance and internal compliance.
- Collaborate with Clinical Operations, Manufacturing, Quality Assurance, Finance, Regulatory, Legal, and other internal and external customers as needed.
- Work with Clinical Operations and Project Management to plan, support, and track study timelines.
- Generate status reports and communicate to department heads as required.
- Managing project budgets for work areas.
- Coordinating IMP’s across multiple clinical trials and geographies.
- Determining and managing packaging campaigns and distribution strategies.
- Liaising with IRT vendors to create supply algorithms.
- Working with CRO’s to assist with Clinical Trial study setup.
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.
- Extensive understanding of global GMP procedures and regulations.
- Experience in a sponsor or CRO environment.
- IRT specification experience.
- 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 HUYA’s Del Mar, California office. Interested candidates should submit resumes to: email@example.com.
To learn more about HUYA Bioscience, please visit www.huyabio.com. HUYA Bioscience is an equal opportunity employer.