Compass Consulting
Clinical Supply Chain Manager
Compass Consulting, San Francisco, California, United States, 94199
Principal Recruiter / Senior Client Relations
Compass Consulting | Life Science Industry
Our client is a research and development company whose mission is to harness advanced technologies to increase our understanding of the biology that controls lifespan.
Location:
San Jose, CA
Salary:
$185,000.00 - $230,000.00
Employment Type:
Contract
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 the Company’s 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.
#J-18808-Ljbffr
Our client is a research and development company whose mission is to harness advanced technologies to increase our understanding of the biology that controls lifespan.
Location:
San Jose, CA
Salary:
$185,000.00 - $230,000.00
Employment Type:
Contract
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 the Company’s 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.
#J-18808-Ljbffr