Key Responsibilities
Clinical Supply Strategy:
- Lead the development and execution of global supply strategies for investigational and commercial materials for early and late stage development programs (new products, indications, or line extensions).
- Participate in the Pharmaceutical Sciences Project Team (PSPT) and Co-Development Team (CDT) to identify and address logistical and regulatory issues.
- Serve as a core study team member to provide operational knowledge for Investigational Product (IP) and lead strategy discussions aligned to protocol and operational needs; anticipate changes based on countries/sites/enrollment, randomization configuration, and protocol requirements.
- Partner with the CST to develop clinical supply solutions, including packaging, blinding, and distribution strategies, to ensure patient compliance, safety, and study needs.
- Identify supply chain risks, develop mitigation strategies, and create contingency plans.
- Manage clinical trial drug supply budgets; communicate forecasts and changes to study teams and GCS partner lines.
- Maintain project information in GCS project tracking systems and PharmSci project management systems.
- Ensure site and patient focus and quality compliance throughout PharmSci and GCS.
- Provide required clinical supply input during audits and regulatory inspections; participate in inspection readiness.
- Participate in Limited Duration Teams and Continuous Improvement projects.
Matrix Team Leadership:
- Matrix team lead of the MedSci GCS Clinical Supplies Team (CST); provide consult on all aspects of clinical drug supply.
Basic Qualifications:
- Bachelor’s (5+ years) OR Master’s (3+ years) OR PhD (0+ years) OR Associate’s (8+ years) OR High school (10+ years).
- Demonstrated ability to manage large, complex clinical development programs.
- Demonstrated knowledge/experience in a GMP (cGMP) and GCP (GxP) environment.
- Understanding of pharma quality and regulatory framework.
- In-depth experience managing multiple clinical studies in parallel.
- Experience leading in a matrix team environment.
- Working knowledge of MS Office and AI tools such as Copilot.
- Drug development/clinical study design experience (e.g., telerandomization) and pharmaceutical manufacturing/packaging/labeling/distribution and import/export.
- Leadership/people management skills (work measurement, negotiation, conflict management, process improvement, project management).
- Ability to develop/communicate execution plans and gain stakeholder support.
- Experience managing change in dynamic, complex environments.
- Experience with budgeting and forecasting.
Nice to Have Qualifications:
- Relevant pharmaceutical experience.
- Operational experience across diverse business portfolios (e.g., biopharmaceuticals, consumer products, other industries).
- Experience presenting orally at conferences and large audiences.
- Breadth of leadership capabilities (influence/collaboration, coaching, guiding work for outcomes/business impact).
Work Location:
- Hybrid
Application instructions:
- Not provided in the text.