From Task Management to Submission Leadership: Why Clear Ownership Comes First

This post is part of a series on the five execution priorities that support the shift from task coordination to submission leadership. 

In an IND (Investigational New Drug Application), delays and quality issues rarely stem from the science. More often, they come from execution: unclear ownership, fuzzy decision-making, timelines built on assumptions, and processes that crack once pressure hits. 

You as the Project Manager (PM) are still expected to deliver in this reality. Timelines are aggressive. Data arrive late. Priorities compete. Accountability is assumed instead of clearly defined. Without real levers to restore control, even a solid plan can unravel quickly. 

That’s why your first (and most important) execution priority is deceptively simple: establishing clear ownership and decision authority early. 

Ambiguity is the risk no one plans for 

When ownership isn’t clear, decisions drift. Reviews loop back. Priorities shift without resolution. Teams hesitate, waiting for direction that never quite comes, until escalation becomes unavoidable and expensive. 

You’ll notice that ambiguity doesn’t announce itself. It shows up quietly: 

• Data are “almost ready,” but no one decides when “almost” is enough to start writing. 

• A document keeps getting revised because no one is empowered to lock the scope. 

• A timeline slips because dependencies were assumed, not owned. 

These are not planning failures, but execution failures. And under compressed timelines, they compound fast. 

Submission management is leadership, not just coordination 

As a submission manager, your role goes far beyond tracking tasks and updating timelines. You’re expected to lead the IND through uncertainty, shifting priorities, and incomplete information. 

Teams look to PMs for stability, clarity, and confidence, especially when things aren’t clean. That means holding the details and the big picture at the same time: keeping responsibilities clear, timelines realistic, and contributors aligned even when inputs are late. 

Strong PMs don’t wait for perfect information. They anticipate risk, surface gaps early, and help the team move forward without forcing false certainty. 

Three questions every PM should answer early 

Clear ownership doesn’t magically appear at kickoff. It must be established, and reinforced. 

Early in the IND, you should be able to answer these questions: 

1. Who truly owns the submission? 
   Not who is listed on an org chart, but who has final decision authority when tradeoffs are required. 

2. What decisions can be made without escalation? 
   Scope freezes, data cutoffs, sequencing changes: clarify what can move forward and what requires approval. 

3. When is “good enough” good enough? 
   Waiting for perfect data or wording is a common source of delay. Define decision thresholds early. 

If you can’t answer these questions clearly, your team probably can’t either. 

Build one source of truth, and protect it 

Clear ownership also means setting expectations around how the work is managed. 

Establish a single, integrated set of timelines and dependencies. Make it clear that this is the reference point for decisions, tradeoffs, and escalation. When multiple versions exist, ambiguity creeps back in. 

This isn’t about control. It’s about momentum. A shared source of truth allows teams to move faster, communicate more clearly, and adjust without chaos when plans inevitably change. 

Clear ownership won’t eliminate uncertainty, but it gives teams a way to navigate it together. And in IND execution, that clarity is often the difference between steady progress and avoidable delay. 

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