Leading Clinical Trial Supply Teams: Insights And Best Practices

A conversation with Isabel Luther, executive consultant, Biotech Bay Consulting LLC

Clinical trial supply teams are a backbone of successful global studies, ensuring investigational products reach patients on time and trials stay on track. Isabel Luther draws on decades of experience in clinical operations and supply chain management to share practical strategies for fostering collaboration, aligning cross-functional teams, and navigating complex supply challenges. Elizabeth Urbanek, executive editor of Clinical Supply Leader, spoke with Isabel to bring these lessons directly to leaders responsible for driving trial success.

How do clinical trial supply teams contribute to the success of global trials from your perspective as a clinical operations leader?

Isabel Luther: Clinical operations really cannot achieve programmatic goals without strong partnerships with supply teams. We cannot launch a program or meet first-patient-in targets without knowing the supply chain is secure. This is true whether you are in a public company with high visibility on timelines or a private company moving out of stealth mode.

In oncology, the stakes are also high because we frequently combine therapies. That means we not only need the investigational product, but we may also need to source comparators or coordinate combination therapies, which adds layers of complexity to global supply chains. Even if clinical operations carries ultimate accountability, the expertise and management from clinical supply teams are critical for success.

Many milestones, both operational and public-facing, cannot occur without close collaboration between operations and supply. From ensuring regulatory timelines are met to confirming patient dosing schedules and managing resupply globally, supply teams are integral to every stage. Without that partnership, it is impossible to keep a trial running smoothly.

What strategies do you use to support clinical supply teams, even when they don’t report directly to you, to ensure smooth supply operations?

Luther: Collaboration at the top can occur at the governance level. In most companies, supply does not report directly to clinical operations. To support teams effectively, I involve the senior accountable person from CMC in governance meetings. Even if activities are outsourced, having CMC leadership present creates transparency, allows early problem-solving, and helps prevent misunderstandings or delays.

Day-to-day support at the management level involves advocating for what the supply team needs — tools, resources, or guidance. Scenario planning is critical. Projecting patient recruitment, site demand, and lead times informs upstream supply decisions. In oncology, if recruitment is slower than expected, that may change the timing for resupply or labeling activities at depots. You need visibility into every step.

In small, growing companies, this also intersects with budgeting and infrastructure decisions. Tools and systems to support supply planning, perhaps AI-assisted modeling, can exceed basic Excel capabilities. Ensuring clinical supply chain teams have what they need up front allows them to perform their jobs effectively. Sometimes that requires influencing leadership on budget allocations for tools and resources over, for example, a one- to three-year horizon.

At the study level, I expect a regular cadence of meetings between clinical operations leadership and supply leadership, including one-on-ones. I also include supply as standing members in project meetings, not just ad hoc contributors. This ensures accountability, keeps workflows on track, and fosters collaboration with vendors. Consistent touchpoints prevent small issues from becoming major problems.

Influencing peers and leadership beyond your immediate team is also critical. Encouraging stakeholders to think ahead about budget, tools, and infrastructure ensures supply teams can meet trial timelines and reduces last-minute firefighting. In essence, it is about creating a culture where supply is fully integrated into operational planning and recognized as a key partner rather than a supporting function.

How do you ensure clinical trial supply teams stay aligned and collaborate effectively with clinical operations across trials?

Luther: Alignment is often a function of influence rather than direct control, especially if supply does not report to you. There are strategies that make collaboration more effective.

Regular touchpoints between study leads and supply leads build familiarity and understanding. Off-site events or social opportunities strengthen relationships and create informal channels for problem-solving. Even small interactions, like virtual coffee chats, help replicate the “bumping into each other” or casual hallway discussion effect that fosters spontaneous communication.

Respecting the stakeholder relationship is key. It is not just about deliverables, it is about understanding the other party’s priorities, constraints, and workflows. Being available and approachable encourages proactive communication and helps resolve issues before they escalate. Over time, these practices help clinical operations and tech ops teams stay aligned and responsive across multiple trials.

Relationship-building is another critical skill. In a previous role at a small oncology company, we faced a serious issue with a CRO managing investigational supply at the site level. Without a strong relationship and mutual trust between clinical operations and the supply team, the problem could have jeopardized the trial — and potentially the company. Because we had cultivated that partnership, we were able to navigate the situation successfully.

These strategies are not just theoretical — they directly impact trial outcomes. For example, when study teams understand supply constraints early, they can consider adjustment to recruitment plans, dosing schedules, and site expectations, potentially preventing costly delays or patient impact. Building this alignment proactively rather than reactively is essential.

What leadership lessons have you learned from overseeing clinical trial supply teams that other operations leaders could apply?

Luther: One of the most important lessons is trust. If you are a clinical operations leader directly managing clinical supply members, trust that they were hired for their expertise, even if you are not a technical subject matter expert in supply chain management. That trust empowers them to make decisions autonomously while ensuring accountability, and it creates a stronger partnership.

Overseeing supply teams also provided an opportunity to develop my own skills in logistics, planning, and cross-functional coordination. By working closely with supply chain, I learned operational details and technical considerations that inform smarter decision-making across the organization.

A further takeaway is the value of embracing supply chain partners fully, even if they do not report to you. Integrating them into the team, metaphorically and practically, creates resilience and enables proactive risk mitigation. Trials are complex, and supply can be the linchpin for success. Teams that collaborate closely from the start are better equipped to anticipate challenges, solve problems efficiently, and deliver results.

Close relationships also allow leaders to leverage supply expertise in areas outside of direct accountability. For example, managing combination therapies or comparators often requires knowledge that is not formally part of clinical operations’ scope, but partnering with supply teams ensures the work gets done successfully.

What advice would you give someone aspiring to lead teams that manage or interact closely with clinical trial supply?

Luther: First, be proactive in communication. In any work setting — remote, hybrid, or in-office — look for opportunities to connect beyond formal deliverables. Create “relationship deposits” through casual interactions, whether virtual coffee chats, informal team discussions, or off-site events. These help build rapport that pays dividends when high-stakes decisions arise.

Second, engage supply teams in risk mitigation, scenario planning, and strategic decision-making. Even if the team does not report to you, strong relationships allow you to leverage their expertise effectively.

Finally, embrace a partnership mindset. Treat supply chain leaders as core collaborators, not external stakeholders. Share accountability for outcomes, involve them in planning, and respect their expertise. Over time, these practices build trust, improve operational efficiency, and ultimately contribute to trial and organizational success.

For example, there was a company where my team (clinical operations) was responsible for combination and comparator therapies because CMC only took accountability for our investigational products. By building strong relationships with the clinical supply chain team, I could leverage their expertise to ensure ClinOps successfully managed these supply chain-specific responsibilities. Think of relationships like a bank account — you cannot withdraw support when you need it if you haven’t made deposits. Being proactive about building trust and rapport pays off when critical decisions or unexpected challenges arise.

Closing Thoughts

Effective clinical trial supply leadership depends on trust, collaboration, and proactive engagement across functions. By treating supply teams as true partners and cultivating strong relationships, clinical operations leaders can anticipate challenges, streamline processes, and ensure trial success. Strong partnerships in supply chain management are essential for keeping complex global trials on track.

About The Expert:

Isabel Luther is an executive clinical drug development consultant with 25+ years of experience, including 20+ in oncology clinical operations. She joined Pionyr Immunotherapeutics and served as VP, clinical operations and overseeing the clinical supply chain until operations wound down after being acquired in 2024. Previously, she was VP, clinical operations at Naked Biome in a consultancy, and sr. clinical program manager at Gilead Sciences, managing multiple oncology assets across clinical phases. Earlier, she held supervisory roles at Onyx Pharmaceuticals, Medivation, and Sugen. Isabel holds a B.A. in psychology from the University of California, Berkeley.