Senior Director, Clinical Supply Chain Strategy

Exelixis Inc; Alameda (CA); On-site; USD 164,500 - 234,500; Full time

Benefits offered by this job

401(k) plan with company contributions

Medical, dental, and vision coverage

Life and disability insurance

Discretionary annual bonus program

Stock purchase program

Long-term incentives

Vacation and holidays

Job summary

Exelixis Inc is seeking a Clinical Supplies Director to lead the development and implementation of clinical supply chain procedures and infrastructure across small molecule and biologics programs.

You will oversee forecasting, labeling, packaging, distribution, and vendor oversight with GMP/GCP/GLP compliance while mentoring staff and collaborating with clinical, regulatory and procurement teams to ensure uninterrupted supplies through development and into launch.

Qualifications

• BS/BA with 13+ years, or MS/MA with 11+ years, or PhD with 8+ years
• Technical experience in drug product manufacturing, analytical testing/QC, and packaging/labeling operations
• Extensive experience implementing procedures and building clinical supply chain infrastructure
• Proven leadership of clinical supplies management for Phase I–III trials and investigator-sponsored studies

Responsibilities

• Develop and implement SOPs, procedures, and infrastructure for consistent processes
• Build vendor capabilities and oversee CMO vendors to meet Exelixis standards
• Oversee scheduling, labeling, packaging, randomization and distribution in GMP mode
• Perform short-, medium-, long-term supply forecast modeling
• Publish monthly inventory reports and manage inventories
• Mentor teammates and lead in a matrix environment

Skills

Clinical supply management

GMP/GCP/GLP knowledge

Analytical skills

MS Office proficiency

Vendor oversight

Education

BS/BA in related discipline

MS/MA in related discipline

PhD in related discipline

Tools

MS Office

Job description

Exelixis Inc is seeking a Clinical Supplies Director to lead the development and implementation of clinical supply chain procedures and infrastructure across small molecule and biologics programs.

You will oversee forecasting, labeling, packaging, distribution, and vendor oversight with GMP/GCP/GLP compliance while mentoring staff and collaborating with clinical, regulatory and procurement teams to ensure uninterrupted supplies through development and into launch.