Senior Associate, Clinical Supply Management

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.

Summary of Job:

The Senior Associate, Clinical Supply Management assists Clinical Supply Managers in the setup, management, distribution, and tracking of clinical trial materials, ensuring the timely and efficient delivery of investigational products to clinical sites. This role requires close collaboration with cross-functional teams, including Clinical Operations, Regulatory Affairs, Quality Assurance, and Logistics, to ensure the successful execution of clinical trials.

Essential Functions:

• Support the CS Managers with the supply planning, forecasting and management of clinical trial materials (CTMs) for ongoing and new clinical studies.
• Assist in overseeing the timely procurement, packaging, labeling, and distribution of clinical supplies, ensuring compliance with regulatory and clinical trial protocols.
• Collaborate closely with the CS Managers and Logistics teams to manage the transportation of bulk clinical shipments from KKC, ensuring compliance with Good Distribution Practices (GDP) and local regulations.
• Manage temperature excursions affecting clinical trial materials, ensuring prompt resolution and documentation.
• Assist in the setup and management of depot systems with the assigned CMO for storage and distribution of supplies.
• Ensure compliance with all relevant regulatory requirements (e.g., FDA, EMA, ICH-GCP, and country-specific regulations) in the management of clinical supplies.
• Support the maintenance and tracking documentation for all clinical supplies, including executed batch records, Certificates of Analysis/Compliance, and filing documents in the electronic Trial Master File (eTMF).
• Participate in audit preparation and support of inspections related to clinical supply activities and assist in resolving any findings or issues.
• Provide regular status reports and updates for internal stakeholders, including clinical operations and study team members.
• Ensure effective communication with clinical trial teams regarding supply requirements, delivery schedules, and potential challenges.
• Collaborate with CS Managers to identify, select, and manage external vendors involved in the production, labeling, and distribution of clinical trial materials.
• Participate in the creation and periodic reviews of Quality Technical Agreements (QTA).
• Support the development and implementation of process improvements to enhance efficiency and quality, including SOPs, Work Instructions and forms.
• Stay current with industry trends, regulatory changes, and technological advancements related to clinical supplies and apply this knowledge to optimize operations.
• Assist Clinical Supplies team with special projects and study related activities as assigned.

Job Requirements:

Education

Bachelor's degree in Life Sciences, Supply Chain Management, or closely related discipline

Experience

Minimum two (2) years of experience in clinical supplies management or a related field, preferably in a pharmaceutical or biotechnology environment.

Technical Skills

• Strong understanding of clinical trial processes, Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
• Experience working with an IRT system preferred.
• Excellent project management, organizational, and problem-solving skills.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external vendors.
• Strong experience using Microsoft Office Suite including Word, Excel and Power Point.

Non-Technical Skills

Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong work ethic is required. Detail oriented and excellent follow through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high growth environment. Has a passion for personal learning and development

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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