Why Early-Stage Startups need Program Management Sooner Than They Think

What Does Program Management in Biotech Really Mean?

Contrary to common perception, Program Management is not just about timelines and status updates. A strong Program Manager (PM) is a strategic integrator, blending IQ and EQ to connect company vision with operational reality, and drive execution.

Key responsibilities include:

• Roadmapping development plans from ideation to key milestones

• Identifying and mitigating risks before they impact the critical path

• Driving cross-functional collaboration across key stakeholders (CMC, regulatory, clinical, and non-clinical teams)

• Facilitating decisions using structured frameworks (e.g., DACI)

• Maintaining alignment between leadership vision, functional goals, partner expectations and on-the-ground reality

• Providing portfolio-level insights for resource allocation, prioritization and long range planning

Program Management is an Investment, Not Overhead

Most early-stage biotechs start lean—often just a founding team and a scientific lead. But as soon as you start layering CMC activities, non-clinical studies, regulatory planning, and external collaborations, complexity increases exponentially. Typically, a PM is either absent or brought in too late—only after execution gaps start impacting progress. As someone who’s led programs from ideation to clinical trials in the U.S. and now consults with companies entering the APAC/US markets, I’ve seen firsthand how embedding program management early on can make or break momentum.

Without early Program Management:

• Science teams become siloed

• Deadlines slip due to untracked dependencies

• Critical decisions get delayed or made with incomplete information

• Investors perceive higher risk and lower operational readiness

With early Program Management:

• Founders/Scientists can stay focused on science and innovation, while PM handles orchestration

• Budgets are aligned with realistic, risk-adjusted timelines

• External partners (CROs, academics, consultants) are managed seamlessly

• Programs stay “pitch-ready” for BD discussions and investor diligence

Whether You Hire or Consult—Start Early

Embedding program management doesn’t always mean hiring a full-time PM on day one.

Firms like BioVertex Consulting provide fractional or project-based support to help companies set up the right structure without sacrificing agility.

So if you’re building an early-stage company or advising one, ask not “Can we afford program management now?” but rather “Can we afford not to?”

📣 Want to explore how embedding program management can accelerate your mission? Let’s talk.

📩 contactus@biovertexconsulting.com
🌐 https://www.biovertexconsulting.com