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Senior Manager / Associate Director, Clinical Supply Chain
- Location: Remote
- Department: Clinical Development & Operations
- Reports To: Head of Clinical Development & Operations
- Employment Type: Full-Time
Company Overview
Nuvectis Pharma (Nasdaq: NVCT) is a clinical-stage biopharmaceutical company focused on the development of innovative therapies for the treatment of immune complement-related conditions and oncology. Our lead candidate is ciprocopan, a Factor B inhibitor for once daily oral administrations, with best-in-class potential, approved in China in July 2026 for treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) in patients previously untreated with complement inhibitors. Our oncology pipeline includes NXP200 (paradox breaking, BRAF kinase inhibitor) and NXP900 (YES1/SRC kinase inhibitor).
Position Summary
This role is responsible for the planning, forecasting, procurement, distribution, and lifecycle management of investigational products (IP) and ancillary supplies across multiple concurrent clinical trials. This role partners closely with Clinical Operations, Regulatory Affairs, CMC/Manufacturing, Quality Assurance, and external vendors (depots, distributors, CROs, packaging/labeling vendors) to ensure uninterrupted, compliant drug supply to clinical sites globally.
Key Responsibilities
- Represent Clinical Supply Chain on cross-functional program teams and governance committees; present supply strategy and risk updates to senior leadership/executive team.
- Develop and maintain IP demand forecasts across multiple trials, factoring in enrollment projections, dosing schedules, expiry/retest dating, and protocol amendments.
- Build and manage supply chain models to optimize inventory levels and minimize waste, overage, and stock-outs.
- Lead scenario planning for enrollment ramp-ups, study delays, and regional expansions.
- Manage relationships with vendors/CDMOs and provide oversight of packaging, labeling, distribution, and depot activities; negotiate contracts, SOWs, and timelines.
- Manage the pack and label process end-to-end; generate master label text and coordinate cross-functional review.
- Oversee comparator sourcing, procurement, and import/export logistics, including country-specific licensing requirements.
- Serve as primary point of contact for IRT/RTSM vendor configuration, UAT, and ongoing system management.
- Ensure all supply chain activities comply with GMP, GCP, and country-specific import/export regulations.
- Partner with QA and CMC on deviation management, temperature excursions, and product quality investigations related to IP.
- Maintain audit-ready documentation for supply chain processes (batch records, chain of custody, temperature logs, COAs/COCs).
- Support regulatory submissions requiring CMC/supply chain input (IND/CTA amendments, IMPD updates).
- Partner with Clinical Operations and CRAs on site-level supply needs, drug accountability, and resupply cycles.
- Work with Data Management/Biostatistics to align randomization and treatment arm allocations with supply strategy, as applicable.
- Collaborate with CMC/Manufacturing on batch release timing, stability data, and expiry extensions.
- Provide supply chain input into protocol design, budget forecasting, and clinical trial agreements.
- Proactively identify and mitigate supply risks (site activation delays, geopolitical/logistics disruptions, manufacturing delays).
- Develop and maintain contingency plans, including secondary sourcing and buffer stock strategies.
- Establish and own clinical supply chain SOPs, systems, and infrastructure as the company scales.
Qualifications
The ideal candidate has:
- 7+ years of clinical supply chain experience in the pharmaceutical/biotech industry, including oncology trial experience.
- Experience managing clinical supply across dosage forms (oral medications, IV, subcutaneous, etc.).
- Hands-on experience with IRT/RTSM platforms (e.g., CUBE, Suvoda, Almac, Signant Health, Endpoint).
- Strong working knowledge of GMP, GCP, and international drug import/export regulations.
- Demonstrated experience managing depot networks, packaging/labeling vendors, and comparator sourcing.
- Experience supporting across Phase I–III, multi-regional trials (US, EU, and/or APAC).
- Excellent cross-functional communication skills; comfortable operating in ambiguity within a small/growing organization.
- Prior experience in a company scaling from Phase 1 to pivotal/registrational trials.
What We Offer
- Competitive base salary and equity.
- Comprehensive health, dental, and vision benefits.
- 401(k).
- Flexible PTO policy.
- Opportunity to build core clinical supply chain infrastructure at a growing biotech.
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