Summary We are seeking a Clinical Supply Manager (CSM) to lead the end-to-end clinical supply management process of our growing clinical portfolio. This role will serve as the primary sponsor contact for external vendors managing the packaging and labeling, storage, distribution, and return/ destruction of clinical supplies.
In a fast-paced, small biotech environment, the CSM will plan, execute and oversee clinical supplies in alignment with trial timelines, budget, regulatory requirements and internal standards. This individual will play a key role in enabling clinical trial start, patient enrollment, and continuous supply as per trial requirements, proactively identifying and mitigating risks, and ensuring compliance of clinical supply with applicable regulations and internal standards.
The ideal candidate is highly collaborative, detail-oriented, and comfortable operating in a hands-on environment, with a focus on building scalable processes, tools, and best practices to support efficient and compliant clinical trial execution.
Your role- Develop and maintain global clinical supply strategies, including forecasting needs for investigational products, comparators, and co-medications
- Oversee inventory levels at depots and clinical sites, defining resupply strategies based on usage trends to prevent shortages
- Coordinate distribution, importing, and exporting of materials
- Ensure all activities comply with Good Manufacturing Practices (GMP), ICH guidelines, and internal standards
- Manage external vendors (incl. budget), such as Clinical Manufacturing Organizations (CMO), packaging partners and depots
- Track vendor performance using metrics, KPIs, and KRIs
- Act as the primary clinical supplies contact for Clinical Trial Teams (CTT), Chemistry, Manufacturing, and Controls (CMC), and quality assurance (QA)
- Organize and coordinate meetings with key stakeholders, including decision tracking and action item follow-up
- Generate optimal distribution plans and develop tools, forms etc. to track and document end-to-end processes
- Trigger and track shipments of clinical supply from central depot to regional hubs and local depots
- Contribute to Information Response Technology (IRT) set-up, testing and maintenance in close collaboration with relevant CTT functions to ensure efficiency, timeliness and accuracy of clinical supplies management
- Provide input into label text as well as into packaging and labeling materials
- Identify and assesses risks and issues related to clinical supplies, proactively communicate them and lead the development and implementation of mitigation strategies and action plans
- Ensure inspection and audit readiness of clinical supplies; participate in internal audits and inspection from health authorities, as required.
What You Bring- 5+ years of supply management experience. Experience in leadership preferred
- Bachelor's degree in Life Sciences, Pharmacy or related field
- Experience working in global clinical development organization
- Experience in Oncology development (preferred)
- Experience in outsourcing and oversight
- Direct experience with health authority inspections of clinical supply management (preferred)
- Knowledge of relevant regulations and guidelines (GMP, ICH guidelines, HSE)
- Knowledge of appropriate supply chain systems used for forecasting and demand planning as well as supply management metrics, KPIs, and KRIs
- Familiarity with other systems used in clinical trials (e.g., CTMS, IRT, eTMF)
- Strong operational excellence with high attention to details
- Strong vendor management and project management skills
- Leadership skills with the ability to lead cross-functional teams
- Strong interpersonal and communication skills
- Strong analytical thinking and decision-making capabilities
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Salary range
$131,200-$196,800 USD
