Job Description
The Director of Clinical Supply Chain will plan, create, implement, build, and optimize the clinical supply chain to ensure uninterrupted and timely clinical drug supply for Ocular’s clinical programs.
Responsibilities:
- End to End clinical supply chain management with focus on late-stage clinical programs.
- Responsible for scenario planning, clinical supply recommendations, and risk mitigation through detailed insight of supply and demand issues for programs of high strategic importance, high cost, and/or under constrained supply
- Manage Interactive Response Technologies (IRT) systems, including system design, URS development, UAT testing, and data management as it pertains to drug product supply. Work collaboratively with Clinical Operations to resolve system related issues.
- Develop and implement global Clinical Supply Chain strategies
- Manage global inventories, shipping, and third-party manufacturers / logistics providers
- Oversee the packaging, labeling, and distribution activities at multiple vendors and CMO’s and manage the supplier relationships. Develop KPI’s and drive deliverables with all supply chain partners.
- Develop, implement, and optimize standardized processes and tools to support the effective and efficient end to end planning of clinical trial materials. Identify supply chain risks.
- Partner with Clinical Operations to align assumptions and build clinical supply to meet program demand
- Lead Clinical Supply Chain on cross functional study execution teams with a strong voice on strategy and overall process design.
- Lead and manage direct reports within Supply Chain
Education and Experience:
- Bachelor's degree is required, Master’s Degree is preferred or equivalent experience
- Late phase clinical development and clinical supply chain management experience required
- Thorough knowledge of Good Manufacturing Practices (GMP)
- Several years’ experience utilizing IRT systems for complex studies
- 10+ years of biotechnology/pharmaceutical industry experience in clinical supply chain management
- Inventory management and third-party logistics oversight experience
- Extensive experience managing clinical demand forecasts
- Prior experience managing late phase studies, including studies utilizing comparators
- Strong global shipping and customs experience
- Extensive experience developing clinical labels
- Experience developing IRT specifications, URS development, and UAT testing.
- Prior experience in ophthalmology trials a plus
- Excellent project management and collaboration skills with multiple stakeholders
- Experience supporting a phase 3 product into commercial launch
Soft Skills:
- Excellent verbal and written communication and skills
- Ability to influence stakeholders from many technical disciplines and at many levels
- Effectively communicate with multiple internal and external stakeholders on expectations and drive results within the clinical supply chain space.
- Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
- A commitment to excellence while working with integrity and honesty
- Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization
- Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others
- Highly accountable for the management of Clinical supply
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