Clinical Supply Chain Senior Consultant

About Dark Horse Consulting Group

Dark Horse Consulting Group (DHCG) is a leading biotherapeutics consulting firm dedicated to accelerating the development and commercialization of cell and gene therapies (CGT) and other complex biotherapeutics. Founded in 2014, DHCG brings together deep scientific expertise, regulatory insight, and operational experience across CMC, Regulatory, Clinical, Nonclinical, Quality & Compliance, Supply Chain, and Commercial Launch.

We work across the full development lifecycle with biotech and pharma companies, CDMOs, technology providers, and investors, helping our clients move faster and smarter through the most challenging phases of drug development. Our three integrated divisions, Dark Horse Consulting, BioTechLogic, and Converge Consulting, give us unmatched breadth and depth across the advanced therapies and biopharma landscape.

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.

Dark Horse Consulting Group is an equal opportunity employer. We welcome applications from candidates of all backgrounds.