Franklin, MA - For venture-backed biotechnology companies, the period immediately following a Series A financing is both exciting and precarious. Capital is finally available to move programs forward, but the pressure to demonstrate meaningful clinical progress is intense. In this environment, leadership teams often prioritize the hires that appear most urgent, clinical operations teams to launch trials, discovery scientists to advance the pipeline, and finance leaders to manage burn.
What many companies underestimate is that some of the most important hires at this stage are the least obvious. Time and again, we see emerging biotech companies delay bringing in leadership in three key areas: Quality, Regulatory Strategy, and Medical Affairs. By the time these roles are filled, companies are often already facing operational or strategic challenges that could have been avoided.
1. Quality Leadership: The Role No One Wants to Fund… Until They Have To
Quality is frequently perceived as a compliance or administrative function that can be addressed later, particularly for companies still early in clinical development. As a result, leadership often relies on consultants, pushes GCP quality responsibilities onto clinical operations teams or CROs, and manages GMP oversight through outside advisors.
This approach can work for a short time, but it becomes increasingly risky as programs approach key milestones such as IND-enabling work, manufacturing scale-up, or Phase II development. Without experienced quality leadership, companies can encounter issues with vendor oversight, data integrity, or manufacturing controls that are far more expensive, and disruptive, to address later.
On the GCP side, one common mistake is hiring the same CRO to both monitor studies and perform quality audits. While this may appear efficient, it eliminates an important layer of independent oversight.
Another pattern we frequently see is companies hiring their first Head of Quality during Phase III development. At that stage, a thorough review of systems and processes may uncover issues uncomfortably close to regulatory submission, issues that could have been addressed years earlier with proper leadership in place.
The most successful companies bring in a Head of Quality earlier than expected, not simply to meet regulatory requirements, but to build systems and oversight that scale with the organization. Quality leadership should not be viewed as overhead. It is risk management for the entire development program.
2. Regulatory Strategy: More Than Just Filing Documents
Regulatory leadership is another function companies often delay. Many CEOs assume regulatory expertise is only required closer to pivotal trial design or submission. Until then, companies frequently rely on fractional consultants, bringing in full-time leadership only when regulatory interaction increases and timelines become more critical during Phase II or Phase III development.
In reality, regulatory strategy should shape development plans from the earliest stages. Decisions made in Phase II often establish the foundation for Phase III development and ultimately influence the commercial pathway. Because of this, maintaining consistency in regulatory strategy throughout development is critical.
A strong regulatory leader helps answer questions that directly affect the value of the company’s program:
- What endpoints will regulators accept?
- How should Phase II trials be structured to support future registration?
- What level of manufacturing readiness will regulators expect?
Without this perspective early on, companies sometimes design clinical studies that fail to generate data regulators consider actionable. The result can be delays, additional trials, and unnecessary capital consumption.
In many cases, a single experienced regulatory leader can dramatically improve how a company interacts with health authorities and how efficiently it progresses through development milestones.
3. Medical Affairs: The Bridge to the Outside World
Medical Affairs is often viewed as a commercial-stage function, something to build once a product approaches approval. However, in modern biotech companies, Medical Affairs leadership plays a critical role much earlier.
Medical Affairs leaders serve as the company’s bridge to key opinion leaders, investigators, and the broader medical community. They help ensure that clinical programs address meaningful questions for physicians and patients. They also play an important role in shaping scientific communication and building credibility with external stakeholders. Key opinion leaders frequently provide insights that influence study design and ensure that trials address clinically meaningful questions.
When Medical Affairs is brought in too late, companies often find that their clinical programs lack the level of physician engagement or real-world insight that could have strengthened trial design and eventual adoption.
Building the Right Team at the Right Time
Every biotech company’s leadership team evolves as the organization grows. The key is ensuring that the functions critical to clinical success are represented early enough to influence strategy.
Quality leadership protects the integrity of the development program. Regulatory leadership ensures that development plans align with how regulators will ultimately evaluate the data. Medical Affairs connects the company’s science with the physicians and investigators who will shape how therapies are understood and adopted.
Series A capital provides an opportunity not only to advance a pipeline, but also to build the leadership team capable of guiding that pipeline through development. The companies that think strategically about these early hires are often the ones best positioned to translate scientific promise into clinical and commercial success.
-Stephen Provost, Managing Director & Co-Founder, Prestige Scientific
About Prestige Scientific:
Prestige Scientific is an executive search firm that advises our clients on recruiting impactful leaders. We provide our clients with a performance-based hiring system that identifies leaders with past success meeting similar corporate objectives as their own, while overcoming challenges and adhering to critical timelines. We have dedicated experts in eleven practice areas that mirror a typical biopharma company, allowing us to support our client's growth from Discovery through Commercial.
