Summary of Position:
Scholar Rock is preparing for its first global commercial launch and is anchoring its Global Supply Chain leadership in Ireland. The Vice President, Global Supply Chain, will serve as the strategic and operational head of Scholar Rock’s worldwide supply chain, accountable for global planning, packaging/labeling, serialization, logistics, distribution, and GDP/GMP compliance.This role establishes Ireland as Scholar Rock’s global supply chain hub ensuring compliance with EU MAH/MIA, and full readiness to support product distribution under U.S. FDA, EMA, and Japan PMDA regulatory frameworks. The VP will ensure Scholar Rock’s products are reliably and compliantly supplied across the U.S., EU, Japan, and Rest of World.
Strategic Leadership
- Define and lead Scholar Rock’s global supply chain and launch strategy across planning, inventory, serialization, risk management, and vendor governance.
- Bring proven experience in commercial launch, global scale-up, and lifecycle management, ensuring uninterrupted product supply across markets.
- Serve as the senior decision-maker for global inventory and distribution control, ensuring compliance with FDA, EMA, and PMDA requirements.
- Partner with executive leadership to support international tax structuring and principal company model.
Global S&OP and Demand Planning
- Establish and lead Scholar Rock’s global S&OP process, ensuring cross-functional alignment between Commercial, Finance, Technical Operations, and Quality.
- Translate demand forecasts into reliable supply and inventory strategies across all markets (US, EU, Japan, ROW).
- Build robust demand planning capability to support launch scale-up, safety stock, and lifecycle management.
- Drive scenario planning and risk assessments to ensure uninterrupted product availability.
- Integrate clinical and commercial demand signals where appropriate, ensuring efficient use of DS/DP capacity across programs.
Global Distribution, Logistics & Serialization
- Establish and oversee worldwide distribution operations from Ireland, ensuring reliable and compliant product supply to all commercial markets.
- Lead global logistics, including cold chain, 3PL management, GDP, customs/HTS compliance, and physical flow control.
- Lead implementation and governance of serialization and track-and-trace systems across EU FMD, U.S. DSCSA, Japan serialization, and other markets.
- Oversee product launch readiness — including supply planning, country launch sequencing, labeling alignment, and inventory build.
Regulatory & Quality Alignment
- Ensure supply chain compliance with EU MAH/MIA, U.S. FDA, and Japan PMDA requirements, maintaining readiness for inspections and audits.
- Partner with Quality and Regulatory to coordinate RP/QP activities, global batch release, and GDP/GMP alignment.
- Ensure global supply chain inspection readiness across GDP, serialization, and distribution operations.
- Ensure supply chain processes and systems meet ICH, GDP, and region-specific expectations.
Organizational & Cross-Functional Leadership
- Build and scale an Ireland-based supply chain team with global strategic and operational expertise.
- Lead a distributed global supply chain organization with staff based in Ireland and the U.S., ensuring seamless coordination across geographies and time zones.
- Collaborate closely with U.S. and global execution teams (Commercial, Clinical, IT/Systems, Finance/Tax) to ensure integrated worldwide operations.
- Provide senior leadership in vendor oversight, cross-functional integration, and inspection readiness.
- Act as the executive supply chain voice in S&OP, portfolio planning, and board-level risk management discussions.
Qualifications & Experience:
- Advanced degree in Supply Chain, Engineering, Life Sciences, or related discipline; MBA or equivalent preferred.
- Biopharma / MedTech Experience: Minimum 15 years in global supply chain leadership, including at least 5 years at senior leadership level
- Launch Expertise: Demonstrated success in commercial product launches, including end-to-end planning, inventory build, serialization, and global distribution readiness.
- Global Regulatory Scope: Proven experience managing supply chain operations under FDA, EMA (MAH/MIA), and PMDA frameworks; direct involvement in inspection preparation and response.
- Serialization / Track & Trace: Hands-on leadership in implementing EU FMD, U.S. DSCSA, and Japan serialization systems, ensuring compliance and inspection readiness.
- S&OP Leadership: Deep experience establishing and leading integrated S&OP processes, with proven ability to align Commercial, Finance, Technical Operations, and Quality functions.
- Demand & Inventory Planning: Strong track record in global demand forecasting, safety stock strategies, and lifecycle supply chain management.
- High-Value Biologics Supply (preferred): Experience managing cold chain logistics, high-value biologics, or advanced therapy supply chains.
- Team Leadership: Demonstrated ability to build and lead high-performing global teams, with staff based across multiple regions (Ireland, U.S., ROW).
- Cross-Functional Influence: Strong executive presence; ability to serve as the supply chain voice in board-level risk discussions, portfolio planning, and tax structuring alignment.
- Vendor & CDMO Oversight: Expertise in managing complex external manufacturing and distribution networks, including 3PLs, packaging/labeling vendors, and serialization partners.
- Strategic Orientation: Skilled at balancing operational execution with long-term supply strategy, risk management, and compliance in a rapidly scaling organization.
Why Join Scholar Rock?
- Lead the establishment of Scholar Rock’s global supply chain and distribution hub, ensuring the right economic substance under the MAH/MIA framework.
- Launch Leadership: Drive global readiness for Scholar Rock’s first rare disease biologic
- Senior leadership role reporting directly to the CTO, with end-to-end accountability for global supply, logistics, and serialization.
- Shape a world-class global supply chain model that balances operational execution, regulatory compliance (FDA, EMA, PMDA), and international tax structuring.
- Build and lead a high-performing global team in Ireland and the U.S., leaving a lasting impact on a patients and the company at a transformative moment.
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