Director/Senior Director, Supply Chain

About the role:

Reporting to the head of Pharmaceutical Sciences, this leader is accountable for all end-to-end Supply Chain activities related to production and supply to ensure uninterrupted product supply for all clinical and commercial programs.  This role is cross-functionally focused throughout the organization, as well as external partners and suppliers.  The head of Supply Chain will provide strategic and operational direction while managing internal and external collaborations to help drive program progression throughout clinical development and commercial.  Working closely internally with CMC, Clinical Operations, Quality, Regulatory and Finance functions, this candidate will establish and implement processes and broaden capabilities to maintain standards for IDRX supply chain excellence. 

The broader IDRx team works primarily remotely and meets in-person in Cambridge, MA once monthly. Opportunities for more frequent in-person collaboration and engagement are possible and are driven by individual interest and availability.

Responsibilities:

• Ensure continuous product supply for all clinical studies and commercial readiness activities
• Establish internal Supply Chain infrastructure to navigate and manage all planning, development and manufacturing related documentation and tools
• Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, to develop forecasts and associated supply/distribution plans
• Communicate and evaluate the drug supply forecast with internal partners to monitor and plan appropriately for drug substance and drug product clinical and projected commercial needs, and program milestones, such as scale-up and/or technical transfer
• Maintain oversight of the production, release, and distribution steps at multiple CROs and CMOs, during various phases of clinical studies and commercial readiness
• Perform supply/demand scenario-planning, as requested, to demonstrate both strategic and financial impacts of path-forward options
• Collaborate with Clinical Operations to provide the appropriate supply related inputs and operational support for IRT/RTSM
• In collaboration with Quality, Regulatory and third party vendors, develop drug product and finished goods labeling strategies, and support the process for label generation and approvals, including regulatory adaptation and translation activities
• Partner with Regulatory, Quality and Technical leads as appropriate to manage plans and timelines to mitigate supply related issues
• Oversee Logistics & Distribution related to product supply, managing third party suppliers
• Provide strategic and operational leadership with respect to the global supply chain function and disciplines, including demand/supply/capacity planning, sourcing, labeling, packaging, inventory management, shipping, and distribution
• Proactively identify critical path/risks to the Supply Chain function, in regards to business decisions and program milestones, and drive the development and communication of mitigation strategies
• In collaboration with Finance, manage the negotiation of contracts broadly across the supply chain with established suppliers, distributors, and vendors
• Contribute to the CMC budgeting process and work closely with Finance on determining cost of goods etc.
• Establish and maintain effective working relationships with key internal and external stakeholders

Requirements:

• Minimum of 15 years in supply management, with 10+ years of relevant experience in drug supply management within the pharmaceutical/life science industry.  Bachelor’s degree in a science or technical area required; MBA or comparable experience preferred.
• Skilled in establishing, maintaining, and managing relationships with CMOs and CPOs.
• Comprehensive understanding of small molecule and solid oral dosage form development, regulatory and quality.
• Experienced in late-stage program development and commercial readiness strategies.
• Excellent communication skills, both written and verbal, keeping key stakeholders and management informed of status, issues and recommended solutions.
• Ability to effectively prioritize and manage tasks in a fast-paced environment.
• At home in a results-driven, highly accountable environment where you can make a clear impact.
• Listens effectively and invites response and discussion.
• Communicates in an open, clear, complete, timely and consistent manner.
• 10%-15% travel required.