Executive Director, Clinical Supply

Execuitve / Senior Director, Clinical Supply

Hybrid (2 days onsite in Bay Area)

Position Summary

The Senior Director, Clinical Supply Chain Management position within Clinical Supply Chain coordinates end-to-end supply chain management on multiple clinical programs as part of a growing, dynamic Pharmaceutical Development organization. They work closely as a key point of contact with Clinical Operations, Regulatory Affairs, Quality, External Manufacturing and vendors leading supply activities for complex programs which may require multinational interactions. The successful candidate will thrive in a highly collaborative team environment to ensure the successful delivery of new drugs.

Responsibilities

• Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing the supply requirements plans. Review clinical trial protocols and understand impact on supply.
• Create, review, and update the clinical supply and demand plans based on strategic elements/study forecasts; apply simulation tools to drive optimal clinical supply plan as appropriate
• Ensure changes in supply configuration, trial design, enrollment timeline, manufacturing availability and regulatory requirements are considered
• Coordinate US and international distribution and logistics for clinical programs
• Monitor enrollment activity and inventory levels at depots and clinical sites through the life of a trial; take preventative actions to avoid potential supply issues
• Manage drug returns process and site close-out activities and prepare drug reconciliation reports
• Manage label development process
• Develop IRT User Requirement Specifications and participate in User Acceptance Testing
• Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
• Communicate with external partners on project requirements
• Monitor, establish, and manage the creation of SOP’s and work instructions that impact the department's day to day operations
• Update relevant Trial Master Files (TMF) with supply related documents
• Achieve operational objectives by contributing information and recommendations to strategic plans and budget reviews
• Collaborate with cross-functional team on regulatory submissions, queries from Health Authorities and participate in Inspections
• Select and apply simulation tools to drive optimal clinical supply plans, as appropriate

Qualifications

• Bachelor’s degree in a related field and 12+ years’ work experience for Senior Director, or a Masters in a Supply Chain or Business-related field and 9+ years’ work experience for Director
• APICS certification (CPIM, CRIM, CSCP) is a plus.
• Proven experience in clinical supplies environment with a strong understanding of clinical study design, execution, and impact of study drug supply from study start-up through trial completion
• Demonstrated experience in inventory management (specifically IXRS systems) and forecasting global drug supply requirements
• General knowledge of GMP and/or GCP, controlled substance management processes and DEA regulations
• Excellent communication and influencing skills, strong collaboration skills and attention to details
• Demonstrated ability to prioritize and manage activities independently in a complex external environment
• Proficient knowledge of demand forecasting, project management and IRT system experience required.
• Oncology Experience is a plus

Salary is $250,000 - $281,000 + robust equity awards, strong benefits, and significant learning and development opportunities.