About the Position
We are in search of an experienced Clinical Supply Chain Senior Consultant with a strong supply planning background to support our clients in the life sciences industry with managing clinical trial materials supply from manufacturing through packaging/labeling to the depots. This role will focus on supply planning, using IRT to supply clinical sites, overseeing CDMO/CPO partnerships, sourcing of ancillary supplies, and supporting the design of packaging, labeling, and global distribution for clinical investigations.
RESPONSIBILITIES
• Act as supply chain lead, as embedded Senior Manager of Clinical Supply Chain, on client's clinical study teams and work cross-functionally with client teams including, Clinical Operations, Quality, Regulatory and CMC.
• Manage all execution of client's cGMP, GCP, and GDP clinical trial supply activities, including pack & label scheduling, depot distribution, inventory management, IRT management, and interpret study protocols.
• Lead selection of partners including pack & label, IRT/RTSM, and comparator/ancillary sourcing.
• Lead cross-functional planning processes such as Clinical Demand and Operations Planning (CD&OP), SIOP, S&OP, IBP
• Create long-term CMC supply plans and short-term labeling and distribution schedules for client, including expiry management and over-labeling.
• Create Inventory Management strategies for client's clinical sites and depots.
• Identify gaps and participate in writing SOPs to support client's processes and create best practices.
• Perform study start-up activities including IRT/RTSM UAT, country and site activation, depot set-up, and initial site supply.
• Perform study close-out activities including investigational product reconciliation, returns, and destruction.
• Participate in consulting project teams to manage clinical supply operations, define client issues and recommend approaches and solutions to address those issues.
• Lead and manage IRT/RTSM builds, including:
o Capturing the protocol requirements
o Leading the User Requirements Specification development with the partner and functional areas
o Authoring UAT scripts, leading UAT testing
o Managing changes through the system to ensure correct functionality is maintained
• Lead the development of sound work plans in partnership with the engagement director, with responsibility for overseeing execution and reporting progress to both client and internal stakeholders.
• Assess client business processes, operational performance, supply chain structures and financial information.
• Advise senior client management, as part of the consulting team, on clinical supply chain strategy.
• Serve as a day-to-day point of contact for client stakeholders and provide guidance and mentorship to junior consulting staff on clinical supply chain methodology.
• Participate in developing and presenting client deliverables.
• Perform secondary research and analysis to understand and develop perspectives on industry trends and practices.
• Contribute to Sales, Marketing, and Business Development initiatives, including supporting proposal development and scoping conversations with prospective clients.
SKILLS AND QUALIFICATIONS
• 7+ years' experience in clinical supply chain management in the biopharmaceutical industry, including
o Managing complex global trials and designing the labeling and global supply chain strategies.
o Supplying clinical trial materials to US, Canada, UK, EU, LatAm, APAC, MENA
o Planning and coordinating label design and packaging activities with third-party CMO partners.
o Utilizing and maintaining IRT for the supply chain role, experience with 4G a plus.
o Creating and managing demand and supply models for clinical trials.
o Selecting and on-boarding partners to support packaging and/or IRT/RTSM
o Experience with cold-chain biologics and cell & gene therapy packaging
o Inspection readiness and eTMF filing
• Familiarity with multiple medical regulatory environments (FDA, EMA, MHRA) and compliance is essential.
• Previous consulting experience is required.
• Demonstrated experience leading workstreams or small teams in a client-facing or consulting environment.
• Strong Excel and PowerPoint skills required.
• CPIM, CSCP, Six Sigma certification a plus
• Relevant undergraduate degree, with MBA or other advanced degree, or equivalent experience.
Why Dark Horse Consulting Group?
• Work at the cutting edge of advanced biotherapeutics, a sector where the science is transformative and the stakes are high.
• Join a team of world-class scientific experts and consultants who are genuinely passionate about what they do.
• Competitive compensation, commensurate with experience.
• Flexible, remote-first working environment.
