Avoid Clinical Alignment Breakdowns With "Lateral Agility"

By Fred Kohler, Kristen Chester, and Molly Rosen, ProjectNext

In the modern life sciences landscape, we are living through a paradox of efficiency. We have AI-driven drug discovery, sophisticated decentralized trial platforms, and more real-time data than ever before. Yet, despite massive investments in technology and process optimization, clinical timelines continue to slip.

When a trial stalls or an IND filing is delayed, the post-mortem usually points to operational complexity or regulatory hurdles. But if you look more closely at the friction points within development organizations — the moments when momentum actually dies — the root cause is rarely scientific. It is human.

For a biotech or pharma firm, internal misalignment is a strategic tax that stalls the clinical timeline, erodes the limited window of patent protection, and jeopardizes the next funding round. To move at the pace the market and patients demand, leadership can no longer just be a vertical exercise of managing down to a team. It must be a lateral exercise of leading across the enterprise. We call this lateral agility.

The Silo Trap: Why Clinical Alignment Breaks Down

Biotech and pharma organizations are structurally designed for conflict. Functions like R&D, regulatory, ClinOps, and commercial are built with their own language, risk tolerance, and incentive structures. In a pressure cooker environment, these functional differences harden into silos:

• The Physician/MD Mindset: Often trained in a modality where they are the ultimate authority on patient safety and clinical judgment
• The Scientist/Ph.D. Mindset: Driven by curiosity and academic rigor, sometimes willing to risk a first patient in (FPI) milestone to run "one more experiment"
• The ClinOps Leader Mindset: Focused on the pragmatic "how" – enrollment velocity, site relationships, and the logistical reality of the protocol
• The Regulatory Leader Mindset: Focused on compliance and strategic gatekeeping, navigating the black and white (and, too often, gray) of filing requirements to mitigate long-term agency risk
• The Commercial Leader Mindset: Focused on market access and incentivized to ensure the therapy is competitively positioned so it reaches patients as quickly as possible

When these functional areas clash without a framework for lateral leadership, the result is a positional standoff. Decisions are not made, and friction is escalated.

Imagine a situation where a trial hits a routine safety signal. The lead physician, acting from a sense of clinical urgency, may demand immediate data from a trial site. To them, it’s a simple phone call. However, the ClinOps lead, protective of a long-standing site relationship and cognizant of the specific terms in the investigator contract, may resist the out-of-cycle or high-pressure request.

In a high-performing team, these two leaders would navigate that tension as partners. But, when the lateral relationship has broken down (or doesn’t exist to begin with), they stop solving the problem and start defending their territory through formal protocols and procedural delays. What should have been a five-minute conversation becomes a weeks-long standoff, stalling the trial’s momentum while the leaders retreat into their respective silos.

What Effective "Lateral Leaders" Do Differently

Leaders who possess lateral agility don't just check the boxes of their own functional KPIs. They optimize for enterprise outcomes. They understand that a win for their function that creates a regulatory red flag is actually a future delay for everyone.

Here are the four behaviors that distinguish leaders who can truly lead across:

1. They Translate Functional Risk

An effective lateral leader recognizes that risk means something different to a quality head than it does to a commercial head. Instead of repeating their position louder, they translate. They move the conversation from "My function needs this" to "The trial needs this. Let’s talk about what this means for your function."

2. They Build Relational Capital

Lateral agility requires relational capital, the history of trust that allows you to ask for a favor or a quick pivot across functional lines. Lateral leaders invest in low-stakes connection time during the quiet periods between milestones. They know that a five-minute informal sync between the head of safety and the head of commercial can prevent a three-week formal escalation when a crisis eventually hits.

3. They Solve for "Shadow Work"

One of the most common maladies in development teams is the "A vs. B" agenda. The team goes to a governance meeting, a decision is made for plan A, yet half the room leaves and continues working on plan B because they weren't truly aligned. This "shadow work" is a massive drain on resources. Lateral leaders don't just seek a "yes" in the meeting; they seek active enrollment. They know that a heated debate in the room is far better than a silent yes that results in months of wasted effort.

4. They Manage Conflict as a Technical Skill

Clinical R&D is inherently conflict-ridden, and it should be. You want the safety lead and the enrollment lead to have a healthy tension. The problem isn't the conflict; it's the management of it. Lateral leaders have the EQ to engage in generative debate without tearing down the cross-functional relationship.

Practical Recommendations For Clinical Development Leaders

To start moving from siloed thinking to lateral agility, we recommend four pragmatic shifts:

• Adopt Cross-Functional Premortems: Before a trial kicks off, get all the critical function leads in a room. Ask: "It’s a year from now and our filing has been rejected. What happened?" This forces divergent assumptions into the light before they become expensive mistakes.
• Establish Lateral Partnership Time as a Leadership Expectation: If your leaders only talk to their peers when there is a fire, the fire will always win. Short, frequent, informal moments build the psychological safety required to speak openly about constraints before they become bottlenecks.
• Clarify Decision Rights (The "D"): Avoid the "too many meetings, no movement" trap. For every major clinical gate, agree on: Who decides? Who must be consulted? And what specific data triggers an escalation to the C-suite?
• Develop and Incentivize Enterprise Leaders, Not Just Specialists: We often promote our best scientists into leadership roles without giving them the tools to lead across. To move beyond functional specialist-mode, development must expand beyond vertical leadership training to include immersive experiences like job rotations, “day in the life” cross-functional panels, and shared decision post-mortems. But development alone isn't enough — organizations must also operationalize this shift. By adding lateral agility to competency models and revamping incentives to reward broader enterprise goals rather than just siloed KPIs, leaders are measured not just on their own team's output but on their ability to lead the entire pipeline.

The Humanity Behind The Science

Clinical development is a race against time, but it is a race run by humans. When we ignore the human parts of leadership — empathy, relationship building, and conflict management — we slow down the science.

The future of clinical development belongs to the leaders who realize that lateral agility is not a nice-to-have soft skill. It is a core capability required to deliver therapies faster and improve trial quality. By investing in the humanity of how we lead, we ensure that lifesaving science can quickly reach the patients who are waiting.

About The Authors:

Fred Kohler is an executive coach and HR leader with 30+ years of global experience across high-tech, pharma, and biotech. He has served as VP of People at 23andMe and Grail, advising leaders and teams on performance, culture, and change.

Kristen Chester is director at ProjectNext Leadership, leading executive cohort programs that translate research into measurable business impact. Formerly a senior manager in Deloitte’s Leadership Practice, she advises senior leaders on strategy, culture, and organizational effectiveness.

Molly Rosen is co-founder and co-CEO of ProjectNext Leadership, where she helps senior leaders navigate transitions and drive organizational impact through executive coaching and leadership development. She has worked with high-performing teams across tech, entertainment, and biotech, and previously held leadership roles at BlessingWhite and Ninth House Networks.