Manager, Clinical Supply Chain Mgmt - Lexington, United States - Kiniksa Pharmaceutical

Description

Reporting to the Director, Clinical Supply Chain the Manager, Clinical Supply Chain Management will be responsible for establishing and managing the end to end clinical supply for clinical studies/programs in various phases.

Successful candidates will possess a fun, flexible, roll up your sleeves attitude, have the ability to work independently and enjoy working in a dynamic, fast-paced environment.

• Ensure continuous supply of clinical trial material for assigned studies globally
• Ensure on-time startup of new studies by having supplies available as required
• Manage clinical packaging and distribution vendors
• Design and execute packaging and labelling campaigns
• Support the procurement, labeling and distribution of comparators
• Review clinical protocols and design appropriate supply chain strategy
• Work collaboratively with Clinical Operations, Quality Assurance and Regulatory Affairs
• Interpretation of a protocol or study overview to calculate total demand and forecast over time
• Managing clinical labeling including label design, translation, and production
• Preparation of a supply plan to support the demand forecast, including determination of supply overage amounts and regular inventory update to project teams
• Manage international distribution and logistics for clinical programs, including importing and exporting clinical supplies globally
• Manage clinical packaging/distribution including negotiating contracts, designing clinical supply plans and developing the distribution instructions with clinical supply chain vendors
• Develop supply strategy to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
• Work with the clinical team to configure and set up Interactive Response Technology (IRT) Systems including automated randomization and drug supply management, including specification design & UAT testing
• Manage study closeouts and drug reconciliation at study end
• Ensure all clinical supply related documents are filed in the eTMF
• Develop and manage clinical supply budget for assigned studies
• Oversee Clinical Supply Chain timelines to ensure on-time completion of deliverables

• Requires a BS degree with 3+ years' experience in a Clinical Supply Chain role in a Biotechnology or Pharmaceutical environment
• Experience managing contract packaging and labeling organizations
• Experience with developing risk-based supply strategy for an early to late-stage clinical development programs
• Thorough understanding of regulatory requirements for clinical supply distribution in US, APAC, and EU including testing and labeling requirements
• Thorough understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials
• Global distribution experience including working with QP, IRT and regional depots.
• Excellent project management and communication skills
• Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• This position does not require travel

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.