Senior Director of Clinical Supply Chain Management

3 weeks ago

Reston, Virginia, United States SciPro Full time

Job Title: Senior Director, Clinical Supply

Job 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. This role requires a strong understanding of clinical study design, execution, and impact of study drug supply from study start-up through trial completion.

Key Responsibilities:

  • Partner with Clinical Operations to identify demand assumptions and review enrollment plans and actuals for use in developing the supply requirements plans.
  • 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 Master's 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.

What We Offer:

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

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