Clinical Supply Chain Manager, Strategic Development

United Therapeutics•Rtp, NC

2d•Hybrid

About The Position

The Clinical Supply Chain Manager, Strategic Development will manage the manufacture, supply, availability, budgeting and delivery of Clinical Trial Material to support all Strategic Development preclinical and clinical trials. This role will facilitate processes to help assure uninterrupted clinical trial material supply.

Requirements

Bachelor’s Degree in a scientific or technical related field
8+ years of experience in the pharmaceutical/clinical research industry with a Bachelor's Degree, or 6+ years of experience in the pharmaceutical/clinical research industry with a Master's Degree
3+ years of relevant clinical supply chain management/work experience
Experience managing and overseeing Clinical Trial Material Vendors
Experience with IVRS/IWRS systems required (developing and implementing IVRS/IWRS systems preferred)
Ability to prioritize, organize and manage multiple projects simultaneously
Working knowledge of GCP and GMP environments and requirements
Familiarity with clinical trial packaging/labeling and/or distribution
Strong customer service and cross-functional interpersonal skills
Working knowledge of clinical trials and the drug development process
Ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and recommends possible solutions to the problem
Ability to adapt to other personalities in a respectful manner that is conducive to the achievement of personal and team goals
The ability to handle many conflicting priorities is critical to build and maintain credibility and respect across the many different constituents in the supply chain
Strong proficiency in MS Office suite, including Word, Excel, and PowerPoint
Excellent oral and written communication

Nice To Haves

Master’s Degree in a scientific or technical related field
Project Management experience
Ability to give professional and concise presentations at internal and external meetings

Responsibilities

Forecast, track, and manage Clinical Trial Material manufacturing and supply chain including raw materials coordination, manufacturing operations packaging and labeling
Attend and participate in study-related meetings to build cross-functional relationships, gather information on study progress and share information on CTM status
Maintain oversight of CTM study files (hard copy & electronic, as appropriate) to ensure they are kept current, accurate, and complete in the TMF
Maintain accurate clinical supply inventory and disposition documentation
Coordinate distribution of clinical supplies to approved investigational sites
Collaborate with Clinical Operations, Quality Systems and Compliance, and Regulatory Affairs departments for clinical trial material planning, forecasting, budgeting, and delivery
Coordinate with CMC and Quality Assurance (QA) partners to manage technical and quality issues to facilitate uninterrupted supplies
Manage and oversee Clinical Trial Material Vendors at a high level
Interface with QA and CMC groups to support release of clinical supplies material and ensure regulatory submissions are up to date
Ensure uninterrupted supplies throughout the duration of clinical studies
Management oversight of the development of processes, procedures, and guidelines to meet short and long-term goals for clinical supplies, including pharmacy manual and SOP creation/maintenance when required
Provide high-level feedback on the development and implementation of IVRS/IWRS systems
Create, coordinate labeling activities at RTP and CMOs e and maintain clinical labels and IFUs for the clinic
Prepare presentations for Investigator Meetings, CRA training, site initiations or other similar training situations
Manage outsourcing activities with various contract vendors to develop project contract, packaging plans, batch records, and distribution strategies for outsourced projects
Assist with clinical audits for all Strategic Development related projects
Attend onsite dosing sessions to assist with training
Coordinate with marketing to help develop final labeling materials for commercial product
Perform other duties as assigned