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 $118,100 to $154,200.  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 (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentives
• Life & Disability Insurance
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

 

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.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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