Manager/Sr Manager Clinical Supply Chain

Vor Bio•Boston, MA

About The Position

The Manager / Senior Manager, Clinical Supply Chain is responsible for the ongoing planning and execution of global clinical supply strategies supporting two (2) late-stage, pivotal clinical studies. This role ensures uninterrupted availability of investigational product (IP) across multiple regions Worldwide while maintaining compliance with GMP, GCP, GDP, and inspection-ready standards. IP is currently PFS-NSD with a migration path to PFS-AI (autoinjector). The position partners closely with Clinical Operations, Quality, Regulatory Affairs, Manufacturing, and external CDMOs to manage increased scale, complexity, and regulatory scrutiny typical of Phase III programs.

Requirements

Manager: 4–6 years of clinical supply chain experience in biotech or pharma.
Senior Manager: 6–8+ years of progressive clinical supply chain experience.
Direct experience supporting Phase III or late-stage clinical trials.
Experience with global IP distribution, depots, and Country-specific labeling.
Strong background working with CDMOs, Packaging vendors, and Clinical 3PLs.
Deep understanding of Phase III clinical supply models and global distribution strategies.
Strong proficiency in IRT systems, Excel-based forecasting, and planning tools.
Adept with Excel, pivot tables, data analyses and able to interpret large data sets.
Use of Smartsheets to create tables, plans, charts and interactive dashboards.
Strong knowledge of GMP, GCP, GDP, and inspection expectations.
Advanced planning, scenario modeling, and risk management skills.
Ability to manage complexity and ambiguity in late-stage programs.
Excellent cross-functional communication and leadership skills.
Bachelor’s degree in Supply Chain, Life Sciences, Engineering, or related discipline

Nice To Haves

Experience supporting programs approaching BLA/NDA submission preferred.
Advanced degree preferred (Senior Manager level).

Responsibilities

Provide clinical supply operational leadership across multiple global clinical studies.
Foster strong cross-functional partnerships to maintain alignment in planning, supply risk management, execution, and compliance.
Coordinate end-to-end logistics for investigational product expiry, labeling, packaging, and distribution to depots and clinical sites, including temperature excursion management.
Lead IP label text creation, translation, approval, and printing activities in support of global regulatory filings, ensuring compliance with local requirements.
Oversee vendors responsible for outsourced clinical supply activities, ensuring deliverables meet scope, timeline, and quality standards.
Forecast and monitor inventory levels and track/manage domestic and international shipments for timely delivery.
Coordinate return and destruction of unused or expired investigational product (IP).
Define Interactive Response Technology (IRT) requirements in collaboration with Clinical Operations and IRT vendor, and lead/document user acceptance testing (UAT) for IRT systems.
Collaborate with stakeholders to develop and maintain the Pharmacy Manual and IP training materials for clinical site personnel.
Ensure all clinical supply activities are conducted in accordance with SOPs, regulatory standards, and Quality requirements.
Serve as primary clinical supply chain contact for CDMOs, packaging and labeling vendors, and clinical logistics providers.
Coordinate IP manufacturing campaigns and packaging runs aligned with Phase III timelines.
Monitor vendor performance, capacity, lead times, and risk indicators.
Ensure all clinical supply chain activities comply with cGMP, GCP, GDP, and global regulatory requirements.
Partner with Quality on batch release, deviations, investigations, CAPAs, and change controls.
Support regulatory submissions (IND amendments, CTA updates) with supply chain documentation.
Act as a core member of the Phase III study team, providing supply chain leadership and risk mitigation.
Partner with Clinical Operations on enrollment forecasting, country strategy, and site activation plans.
Communicate supply status, risks, and mitigation strategies to senior leadership and governance forums.
Own and maintain Phase III clinical supply plans, dashboards, and KPIs.
Leverage IRT/RTSM systems and planning tools to support resupply and inventory visibility.
Drive process improvements to improve scalability, compliance, and cost efficiency.