Remote Clinical Supply Chain Senior Consultant, BiotechCGT

Dark Horse Consulting Group; Raleigh (NC); A distancia; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Remote-friendly environment

Competitive compensation

Descripción de la vacante

Dark Horse Consulting Group is seeking an experienced Clinical Supply Chain Senior Consultant to manage end-to-end supply planning for clinical trials, from manufacturing to depots. You will oversee IRT/RTSM, CDMO partnerships, and global distribution, while shaping packaging and labeling strategies for CGT programs.

You will lead cross-functional teams, mentor juniors, and design long-term supply plans. This remote-friendly role requires deep regulatory knowledge and consulting experience in

Formación

• 7+ years of clinical supply chain management in biopharma.
• Experience designing labeling and global supply chain strategies.
• Experience supplying materials to US, Canada, UK, EU, LatAm, APAC, MENA.
• Experience with IRT/RTSM and packaging with CMOs.
• Experience creating demand/supply models for clinical trials.
• Experience selecting and onboarding packaging/IRT/RTSM partners.
• Knowledge of cold-chain biologics and CGT packaging.
• Inspection readiness and eTMF filing experience.
• Familiarity with FDA, EMA, MHRA regulatory environments.
• Consulting or client-facing leadership experience is required.
• Strong Excel and PowerPoint skills.
• CPIM, CSCP, Six Sigma certification is a plus.
• Relevant undergraduate degree; MBA or advanced degree preferred.

Responsabilidades

• Act as supply chain lead on client clinical study teams, interfacing with Clinical Operations, Quality, Regulatory and CMC.
• Manage all clinical trial supply activities per cGMP, GCP and GDP, including depot distribution and IRT management.
• Lead partner selection for pack & label, IRT/RTSM, and ancillary sourcing.
• Oversee CD&OP, SIOP, S&OP, IBP planning processes.
• Create long-term CMC supply plans and short-term labeling/distribution schedules.
• Develop Inventory Management strategies for sites and depots.
• Identify gaps and contribute to SOP writing for client processes.
• Lead study start-up and close-out activities including IRT UAT and depot setup.
• Support client deliverables and contribute to Sales/BD efforts.
• Oversee IRT/RTSM builds: capture protocol needs, write UAS specs, author UAT scripts, manage changes.
• Develop work plans with engagement director and report progress to stakeholders.

Conocimientos

Clinical supply chain

Global trials

IRT/RTSM

CDS planning with CMO

Demand & supply modeling

Partner onboarding

Cold-chain packaging

eTMF familiarity

Regulatory knowledge (FDA, EMA, MHRA)

Consulting / client-facing

Leadership / mentoring

Excel

PowerPoint

CPIM/CSCP/Six Sigma

MBA or advanced degree

Educación

Undergraduate degree in life sciences/engineering/pharma

MBA or advanced degree (preferred)

Herramientas

Excel

PowerPoint

Descripción del empleo

Dark Horse Consulting Group is seeking an experienced Clinical Supply Chain Senior Consultant to manage end-to-end supply planning for clinical trials, from manufacturing to depots. You will oversee IRT/RTSM, CDMO partnerships, and global distribution, while shaping packaging and labeling strategies for CGT programs.

You will lead cross-functional teams, mentor juniors, and design long-term supply plans. This remote-friendly role requires deep regulatory knowledge and consulting experience in