Compass Consulting
Clinical Supply Chain | Contractor
Compass Consulting, South San Francisco, California, us, 94083
Base pay range
$85.00/hr - $90.00/hr
Clinical Supply Chain Consultant Our Client is seeking an experienced, highly motivated clinical supply chain consultant to lead end-to-end supply chain management for a diverse portfolio of small molecule and biologic drug candidates, from clinical development through future commercialization.
The position focuses on developing and implementing robust supply strategies, ensuring compliant delivery of investigational medicinal products (IMPs) to global clinical trials and managing commercial supply for launched products. The ideal candidate possesses deep expertise in clinical supply chains, strong leadership, and a proven track record optimizing complex logistics in a highly regulated environment.
Hours: 40 hours per week for six months minimum. Conversion to an FTE role if the team member demonstrates a technical and cultural fit at the company and alignment with Companies Core Values.
Key Responsibilities
Strategic Leadership: Develop and optimize global supply chain strategies for clinical (small molecule/biologic) programs, aligning with development plans, future commercialization, regulatory needs, and corporate objectives.
End-to-End Supply Management: Oversee all supply chain aspects, including:
Clinical Supply: IMP demand forecasting, packaging, labeling, distribution, returns, and destruction for global clinical trials, ensuring timeline and budget adherence.
Comparator Sourcing: Strategically plan and execute the sourcing, procurement, and management of comparator products for clinical trials, ensuring quality, authenticity, and timely delivery.
Commercial Supply: Strategic planning, launch readiness, manufacturing coordination, inventory, warehousing, and distribution for commercial products.
Transition Management: Lead seamless transition of drug products from clinical development to commercial supply, including tech transfer, scale-up, and commercial readiness.
Cross-functional Collaboration: Lead cross-functional teams (Clinical Ops, QA, Regulatory, Manufacturing, CMC, Commercial, Finance) for integrated execution across the product lifecycle.
Vendor & CMO/CDMO Management: Select, help qualify, and manage third-party vendors, CMOs, and CDMOs for clinical packaging/labeling, storage, distribution, and commercial manufacturing, ensuring performance against KPIs/SLAs.
Forecasting & Planning: Lead accurate clinical supply forecasting (based on trial design/enrollment) and robust commercial forecasting (with commercial teams), translating into comprehensive supply plans.
Risk Management: Proactively identify supply chain risks (e.g., manufacturing delays, regulatory changes, logistics, market fluctuations) and develop mitigation strategies for uninterrupted clinical and commercial supply.
Regulatory Compliance: Ensure all supply chain activities comply with global GMP, GDP, GCP, and relevant regulatory requirements (FDA, EMA, Health Canada, etc.) for clinical and commercial products.
Process Improvement: Drive continuous improvement in supply chain, implementing best practices, new technologies, and efficient processes to enhance effectiveness, reduce costs, and improve reliability.
Budget Management: Develop and manage the overall supply chain budget for programs/products, tracking expenditures and identifying cost efficiencies.
Documentation: Ensure meticulous documentation and record-keeping for all supply chain activities, ready for audit/inspection.
Qualifications
Education: Bachelor’s degree in Life Sciences, Pharmacy, Business, or a related field. Advanced degree preferred, but not required.
Experience: 10+ years progressive supply chain experience in pharma/biotech; demonstrated expertise managing clinical and commercial supply chains for small molecule/biologic products across all development phases and commercialization, including product launch.
Proven experience in comparator sourcing and management for global clinical trials.
Technical Skills:
In-depth knowledge of global regulations for pharma supply chains.
Strong understanding of drug development, clinical operations, and commercialization strategies.
Proficient in supply chain forecasting, ERP/MRP, IRT and logistics.
Experience with cold chain management for biologics.
Familiarity with import/export regulations.
Knowledge of global regulations and best practices for comparator product sourcing.
Leadership & Soft Skills:
Exceptional leadership, communication, and interpersonal skills, influencing and collaborating with diverse stakeholders.
Proven strategic thinking, problem-solving, and decision-making under pressure.
Strong project management, managing multiple priorities in a fast-paced environment.
Detail-oriented, committed to quality, compliance, and operational excellence.
Adaptable and able to lead through ambiguity.
Please note this role is NOT Eligible for C2C.
Seniority level Mid-Senior level
Employment type Contract
Job function Supply Chain
Industries Biotechnology Research and Pharmaceutical Manufacturing
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Clinical Supply Chain Consultant Our Client is seeking an experienced, highly motivated clinical supply chain consultant to lead end-to-end supply chain management for a diverse portfolio of small molecule and biologic drug candidates, from clinical development through future commercialization.
The position focuses on developing and implementing robust supply strategies, ensuring compliant delivery of investigational medicinal products (IMPs) to global clinical trials and managing commercial supply for launched products. The ideal candidate possesses deep expertise in clinical supply chains, strong leadership, and a proven track record optimizing complex logistics in a highly regulated environment.
Hours: 40 hours per week for six months minimum. Conversion to an FTE role if the team member demonstrates a technical and cultural fit at the company and alignment with Companies Core Values.
Key Responsibilities
Strategic Leadership: Develop and optimize global supply chain strategies for clinical (small molecule/biologic) programs, aligning with development plans, future commercialization, regulatory needs, and corporate objectives.
End-to-End Supply Management: Oversee all supply chain aspects, including:
Clinical Supply: IMP demand forecasting, packaging, labeling, distribution, returns, and destruction for global clinical trials, ensuring timeline and budget adherence.
Comparator Sourcing: Strategically plan and execute the sourcing, procurement, and management of comparator products for clinical trials, ensuring quality, authenticity, and timely delivery.
Commercial Supply: Strategic planning, launch readiness, manufacturing coordination, inventory, warehousing, and distribution for commercial products.
Transition Management: Lead seamless transition of drug products from clinical development to commercial supply, including tech transfer, scale-up, and commercial readiness.
Cross-functional Collaboration: Lead cross-functional teams (Clinical Ops, QA, Regulatory, Manufacturing, CMC, Commercial, Finance) for integrated execution across the product lifecycle.
Vendor & CMO/CDMO Management: Select, help qualify, and manage third-party vendors, CMOs, and CDMOs for clinical packaging/labeling, storage, distribution, and commercial manufacturing, ensuring performance against KPIs/SLAs.
Forecasting & Planning: Lead accurate clinical supply forecasting (based on trial design/enrollment) and robust commercial forecasting (with commercial teams), translating into comprehensive supply plans.
Risk Management: Proactively identify supply chain risks (e.g., manufacturing delays, regulatory changes, logistics, market fluctuations) and develop mitigation strategies for uninterrupted clinical and commercial supply.
Regulatory Compliance: Ensure all supply chain activities comply with global GMP, GDP, GCP, and relevant regulatory requirements (FDA, EMA, Health Canada, etc.) for clinical and commercial products.
Process Improvement: Drive continuous improvement in supply chain, implementing best practices, new technologies, and efficient processes to enhance effectiveness, reduce costs, and improve reliability.
Budget Management: Develop and manage the overall supply chain budget for programs/products, tracking expenditures and identifying cost efficiencies.
Documentation: Ensure meticulous documentation and record-keeping for all supply chain activities, ready for audit/inspection.
Qualifications
Education: Bachelor’s degree in Life Sciences, Pharmacy, Business, or a related field. Advanced degree preferred, but not required.
Experience: 10+ years progressive supply chain experience in pharma/biotech; demonstrated expertise managing clinical and commercial supply chains for small molecule/biologic products across all development phases and commercialization, including product launch.
Proven experience in comparator sourcing and management for global clinical trials.
Technical Skills:
In-depth knowledge of global regulations for pharma supply chains.
Strong understanding of drug development, clinical operations, and commercialization strategies.
Proficient in supply chain forecasting, ERP/MRP, IRT and logistics.
Experience with cold chain management for biologics.
Familiarity with import/export regulations.
Knowledge of global regulations and best practices for comparator product sourcing.
Leadership & Soft Skills:
Exceptional leadership, communication, and interpersonal skills, influencing and collaborating with diverse stakeholders.
Proven strategic thinking, problem-solving, and decision-making under pressure.
Strong project management, managing multiple priorities in a fast-paced environment.
Detail-oriented, committed to quality, compliance, and operational excellence.
Adaptable and able to lead through ambiguity.
Please note this role is NOT Eligible for C2C.
Seniority level Mid-Senior level
Employment type Contract
Job function Supply Chain
Industries Biotechnology Research and Pharmaceutical Manufacturing
#J-18808-Ljbffr