Clinical Supply Chain Lead

About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific.

Our Culture 
Pharming is committed to our core values: “We Care, We Collaborate, We Walk the Talk”, which is complementary to our focus on self-development of our people, teamwork, leadership and being results orientated. In our growing organization, it is important that employees feel connected and engaged.  Our core values enable our mission of bringing the unserved rare disease patients the solutions they need and create a clear pathway forward to meet our strategic goals and objectives.

Purpose of the rol:

The Clinical Supply Chain Lead is a key strategic and operational role within the pharmaceutical industry, responsible for designing, managing, and optimizing the clinical supply chain, specifically for packaging and labeling. This role ensures the efficient and seamless execution of global clinical trials by aligning clinical supply strategies with organizational objectives, regulatory standards, and patient needs. The Clinical Supply Chain Lead plays a critical part in overseeing the availability of investigational medicinal products (IMPs) at the right place, time, and quantity, and ensures compliance with industry regulations throughout the process. The position requires in-depth knowledge of pharmaceutical development, regulatory requirements, and clinical supply chain logistics to effectively support the successful progression of clinical trials.

Areas of responsibility
Strategic Planning & Optimization:

• Develop and implement clinical supply strategies (Pack and Label) that align with the pharmaceutical pipeline, ensuring supply continuity and cost efficiency.
• Lead demand forecasting and supply optimization by leveraging historical data, patient enrollment projections, and market trends.
• Collaborate with the CMC (Chemistry, Manufacturing, and Controls) team, QA and Clinical Operations to integrate clinical supply strategies into the broader drug development process.
• Drive innovation by identifying and implementing new technologies, digital tools, and process improvements for enhanced clinical supply chain visibility and efficiency.
• Establish and manage strategic relationships with Pack and Label CMOs (Contract Manufacturing Organizations), CROs (Contract Research Organizations), and logistics providers to build a resilient and agile clinical supply network.

Clinical Supply Chain Coordination & Execution:

• Oversee clinical supply process, starting from secondary packaging, labeling, distribution, and return of clinical trial materials.
• Ensure alignment of clinical supply chain activities with manufacturing activities (DS, DP and primary packaging).
• Ensure alignment of clinical supply chain activities with clinical study timelines, patient enrollment plans, and protocol amendments.
• Develop customized clinical supply strategies for different study phases (early-phase, pivotal trials, and post-marketing studies) while considering factors such as drug stability, cold chain requirements, and site-specific needs.
• Implement and maintain Interactive Response Technology (IRT) systems for real-time tracking of clinical supply levels, ensuring proper inventory allocation across global trial sites.Review and/ or draft study clinical supply related documents such as pharmacy manual/ clinical protocols. 

Risk Management & Contingency Planning:

• Proactively identify and mitigate risks related to clinical supply shortages, and geopolitical challenges.
• Develop contingency plans for clinical supply disruptions, including backup Pack and Label sites, alternative sourcing options, and demand-based allocation models.
• Leverage predictive analytics and scenario planning to anticipate future clinical supply needs and optimize decision-making.

Regulatory Compliance & Quality Assurance:

• Ensure full compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and global regulatory guidelines (FDA, EMA, MHRA, PMDA, etc.).
• Collaborate with Pack and Label vendor and QA  to ensure country-specific compliance for import/export and labeling.
• Maintain audit-ready documentation and ensure complete traceability of clinical trial materials throughout the supply chain.

Performance Metrics & Continuous Improvement:

• Define and track key performance indicators (KPIs) to measure clinical supply chain reliability, efficiency and cost-effectiveness.
• Conduct post-study evaluations to analyze clinical supply chain performance and implement process improvements for future trials.
• Drive a culture of continuous improvement by staying updated on industry trends, emerging regulatory requirements, and technological advancements in clinical supply chain management.

Your Profile
Knowledge: 

• Bachelors or University degree (bio)pharmaceutical sciences, (bio)chemistry or equivalent.
• Extensive knowledge of GMP regulations for EU and US (GMP, GLP and GDP) and the use of quality systems.
• Good knowledge and experience with ERP and EDMS systems.
• Preferably knowledge and experience of Project management.

Experience:

• Six years of experience in (bio)pharmaceutical environment with at least four years in Quality Assurance. 
• At least 4 years experience with the use and improvement of Quality Management Systems.
• Awareness of GxP regulations (EU, US) and US-CFR21 part 11.

What you'll get in return
We offer you a permanent position (starting with a one-year contract), with an excellent remuneration scheme, including:

• A highly competitive salary
• 8.33% holiday allowance (for NL)
• A minimum of 30 vacation days
• An excellent pension plan
• Commuting allowance

You will also join our Learning & Development program, which can offer a tailor made development plan, based on your personal and professional needs. Learning opportunities are everywhere, in all forms imaginable and we want to create learning memories for all “Pharmers”.

Also important! We truly value a healthy life-work balance with a lot of flexibility.

Apply for the job
Does this sound like you and do you want to join our team? Then we'd love to hear from you!

We’re an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.