Fix decision rights. Ship a 14‑day leadership cycle.

When Milestones Drift, It's Usually Not the Science

Most biotech delays don't trace back to the lab. They happen in the handoffs—between biology and CMC, between data and the board deck, between "we think we're ready" and "we're confident enough to file."

The gap isn't scientific. It's structural.

The Pattern: Nobody Owns the Boundaries

In specialist-led organizations, accountability lives within functions but disappears between them. Your Head of Biology knows the target. Your CMC lead knows manufacturing. But who owns the decision to move from lead optimization to IND-enabling studies?

When no one has clear authority to make the call, scope expands and timelines slip—not because the work is hard, but because decisions wait for consensus that never quite forms.

Is this your problem?

Ask your team: "Who decides whether we're IND-ready?"

If the answer involves three or more people, or "we'd need to discuss it as a group," accountability is too diffuse. Another tell: Do decisions wait when key people are out?

What Works: Split Scientific Judgment from Execution Accountability

The teams moving fastest assign two distinct roles per major milestone:

Asset Lead – Owns the scientific thesis and makes the judgment call: "Is the data sufficient to move forward?"

Program Lead – Owns execution, manages dependencies across functions, and surfaces risks before they become crises. Has the technical depth to evaluate quality of evidence, not just completion of tasks.

The Asset Lead has veto authority on scientific decisions. The Program Lead has escalation authority when timelines are at risk.

When you need both vs. one:

• Pre-IND: Often one person (your CSO)

• IND to Phase 1: You likely need both

• Phase 2+, multiple assets: Definitely both, per asset

This doesn't work if:

• Your team is under 10 people

• You're still in target validation

• Your functional leads aren't willing to share authority

Evidence: What This Looks Like in Practice

A mid-stage oncology company restructured their IND prep around this model. Instead of monthly cross-functional reviews, they seated Biology, CMC, and Clinical in weekly working sessions with clear decision rights.

Their go/no-go cycles compressed from roughly three months to about five weeks—not because anyone worked faster, but because they removed wait time between functions.

More importantly, their CMC team caught a formulation stability issue several months earlier. Why? The Clinical lead asked in a weekly session: "If we're dosing in Q3, when do we need final formulation locked?"

That question had never been asked explicitly because Clinical and CMC only connected monthly. The early catch let them reallocate budget from a non-viable formulation to the backup candidate before burning through full development spend.

The Shift in Practice

Traditional model: Biology completes work → presents to CMC → CMC schedules follow-up → Clinical weighs in Result: 6-8 weeks of calendar time for decisions needing 6-8 hours of work

Milestone-focused model: Small cross-functional team (4-6 people) owns the IND end-to-end with weekly 30-minute "What's blocked?" sessions Result: Decisions happen when data is ready, not when the meeting schedule allows

What this requires: Clear decision rights. What can we decide? What needs exec approval? Without this clarity, you've just created another meeting structure.

How to Actually Do This

Week 1: Pick your pilot milestone

Choose something near-term and high-stakes:

• IND submission in 6-9 months

• Phase 1 dose-escalation decision

• Lead candidate selection

Not: Anything over a year out or routine work.

Week 1-2: Identify your leads

Asset Lead: Who will defend this science to the board? Usually your CSO, VP of Research, or Head of Translational Medicine.

Program Lead: Who can evaluate evidence quality across Biology, CMC, and Clinical? Who has credibility to push back on a CRO timeline?

Not your best project manager—your best technical operator who understands the whole chain.

If you don't have someone technical enough for Program Lead: This is your real constraint. You need to hire for it, develop someone over 6-12 months, or bring in interim support.

Week 2: Get functional leader buy-in

This is where most attempts fail. Your Head of CMC will resist if they think you're diluting functional excellence.

The conversation: "We're running a pilot for [milestone]. [Name] will spend ~20% of their time in a cross-functional team. They still report to you. After 8-10 weeks, we'll evaluate together."

If functional leaders won't commit one day per week, you have a cultural problem needing executive attention first.

Week 3-4: Form the team

Pull 4-6 people: Biology (1-2), CMC (1), Clinical Ops (1), Regulatory (1, part-time), optional Data/Biostats.

First meeting:

1. What's the milestone? (Specific: "IND submitted to FDA")

2. What needs to be true to get there?

3. What's blocked today?

4. What can this team decide vs. escalate? (Write it down)

Ongoing: Weekly 30-minute standup, shared risk register, decision log for scope/timeline/budget changes.

Week 12: Evaluate

Ask the team:

• Decisions faster?

• Catching risks earlier?

• Standup adding value?

• Clear on decision authority?

Ask functional leaders:

• Person still delivering functionally?

• Earlier visibility into issues?

• Support expanding this?

If no, diagnose:

• Decision rights unclear → Define boundaries better

• Program Lead lacks authority → Wrong person or leaders haven't delegated

• Team optimizing for function → Culture issue

• Standup feels like overhead → You're doing status updates, not blocker resolution

What Good Looks Like

You'll know it's working when:

• Someone asks "Who's in charge of the IND?" and everyone gives the same name

• Risks surface in days, not weeks

• Board meetings get shorter

• Decisions don't wait for monthly reviews

Most reliable early signal: Your Program Lead escalates something within 48 hours that would have stayed buried for weeks under the old model.

When This Doesn't Fit

Works best for:

• IND-stage through Phase 2

• Organizations with 15+ people

• Leadership willing to delegate authority

Probably wrong for:

• Very early discovery (no clear milestone)

• Late-stage, stable programs (functional teams are fine)

• Organizations under 10 people (everyone's already talking; this adds overhead)

What Are You Seeing?

Are milestone timelines drifting in your programs? And if so, is it because decision rights aren't clear, or something else?

Worth comparing notes.

—Roop