CMC Clinical Supply Chain Consultant

Duration: 6 months, potential for extension

Start: June 2026

Hours: 20–30 hrs/week minimum, ideally up to 40 hrs/week. Hourly workload could fluctuate during project.

Location: Preference for onsite/hybrid in San Diego (flexible/negotiable). Strong remote candidates willing to support West Coast hours will also be considered.

Overview

Our biotech client is seeking a highly experienced CMC Clinical Supply Chain Consultant to support ongoing clinical development programs and work closely with the Head of CMC and parent company stakeholders. This consultant will provide hands-on leadership across global clinical supply chain operations, including packaging, labeling, distribution, forecasting, vendor oversight, and clinical supply strategy execution.

The ideal consultant will bring a strong blend of strategic leadership and operational execution experience within clinical-stage biopharma environments. This is a highly collaborative role requiring close partnership with CMC, Clinical Operations, Regulatory, QA, and external vendors.

Responsibilities

• Lead clinical supply chain activities supporting global and domestic clinical trials
• Manage investigational product (IP/IMP) planning, forecasting, packaging, labeling, distribution, reconciliation, and destruction activities
• Oversee external vendors including depots, packaging/labeling providers, and IVR/drug distribution partners
• Develop and execute clinical supply chain strategies to ensure uninterrupted study support and efficient inventory management
• Support study-specific supply planning and demand forecasting activities
• Partner cross-functionally with CMC, Clinical Operations, QA, Regulatory, and Project Management teams
• Support development and management of IXRS specifications and unblinded supply activities
• Drive operational excellence across supply accountability, risk mitigation, compliance, and logistics execution
• Establish KPIs and communicate supply strategy updates and risks to leadership
• Collaborate with commercial supply chain stakeholders to support program transitions

Required Experience

• BS degree minimum
• 10+ years of pharmaceutical/biotech industry experience within clinical supply chain, CMC operations, or related functions
• Director or Senior Director-level experience within biotech or pharmaceutical companies
• Strong experience overseeing global clinical packaging, labeling, distribution, and inventory management activities
• Experience serving as a Clinical Supply Lead for clinical-stage programs
• Deep understanding of GMP, GCP, ICH guidelines, and global clinical supply regulations
• Experience with IXRS design, implementation, testing, and management
• Strong vendor management and cross-functional stakeholder leadership experience
• Ability to operate both strategically and tactically in a fast-paced biotech environment
• Excellent communication and executive-facing collaboration skills
• Proficiency in Microsoft applications, EDC systems, and inventory management tools.
• Expertise in finance, risk management, and complex distribution/labeling strategies.

Preferred Background

• Experience supporting early to mid-stage clinical development programs
• Prior experience working in lean or emerging biotech environments
• Ability to work onsite regularly in San Diego