Manager, 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 translate science into smiles by delivering therapies 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, North Carolina, and Mississauga, Ontario.

Summary of Job:

Responsible for managing clinical trial material Packaging, Labeling, distribution, and storage according to local and global regulations.

Essential Functions:

• Proactively and strategically manage procurement, packaging, labeling, distribution, returns, depot reconciliation, destruction, and storage tasks for all clinical trial material, which may include ancillary supplies and/or medical devices.
• Create department SOPs and Work Instructions on local and global levels as needed.
• Establish global and regional Clinical trial supply strategy and oversee execution. Collaborate across departments and regions to develop, maintain, and refine cross functional business processes.
• Provide PM with a Clinical Supplies budget for activities based on vendor cost to ensure all project objectives are met in a timely and compliant manner within the approved budget.
• Provide support to source comparators, placebos, and combination therapies; assist QA in any recall activities.
• Assist with agency inspection readiness as needed.
• Manage vendor oversight activities and vendor performance to ensure high-quality, cost-effective execution of outsourced clinical supply activities.
• Work with global team to manage global clinical studies

Job Requirements:

Education:

Bachelor’s degree in Supply Chain Management, Life Science or closely related discipline. Advanced degree/certification preferred.

Experience:

• Minimum four (4) years experience of Clinical supply management, preferably within the pharmaceutical/biotechnology industry, and or CMO/CDMO.
• Strong experience ensuring compliance with local and global regulations (e.g., FDA, EMA, ICH guidelines)
• Proven track record managing Investigational drug product primary/secondary packaging and labeling and distribution process
• Familiarity with clinical trials processes and timelines.
• Prior leadership experience managing teams and external vendor/suppliers.

 Technical Skills

• Strong experience using Microsoft Office Suite including Outlook, Project, Excel, Power Point and Word.
• Strong written, verbal, interpersonal and listening communication skills:
• Experience in inventory management system and system integrations is a plus. IRT experience required.
• Understanding of regulatory requirements impacting packaging, labeling, and distribution of clinical trial materials.
• Ability to analyze supply chain data and generate reports to support decision-making.
• Excellent project management skills with ability to manage multiple projects concurrently.

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 to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.

Physical Demands: Normal office environment with prolonged sitting and extensive computer work.

Working Conditions: Requires up to 5% domestic and international travel

The anticipated salary for this position will be $142,400 to $167,500 The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Discretionary Profit Sharing
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits