From science to scale: building biotech companies via milestone leadership

Leadership quality is a decisive factor in venture capital success, with investors scrutinizing founder and executive capabilities as rigorously as they evaluate scientific innovation. In our recent study on leadership in VC-backed companies, we found that organizations that proactively assess, develop, and evolve their leadership teams across critical growth stages dramatically outperform those that treat talent as an afterthought.

But how do biotech companies operationalize this insight? Their challenge is particularly acute, as biotechs face multiple critical junctures that presage specific new competencies to meet the next milestone. Leadership competencies, for example, required to validate a scientific hypothesis in Phase I bear little resemblance to those needed to prepare for commercial launch in Phase III. To address this challenge, we introduce the concept of milestone leadership, a structured approach that encompasses proactively building leadership capabilities, team composition, workforce flexibility, and organizational culture in lockstep with a company’s development milestones. Drawing on our work with biotech investors, CEOs, and board members, this framework provides a practical protocol for navigating critical transitions that separate scientific promise from commercial success.

The Leadership Scorecard: defining success at each milestone

Before exploring how leadership must evolve across biotech milestones, we need to first establish what success looks like at each stage. This is where the leadership scorecard becomes essential: a structured framework that defines the specific competencies, behaviors, and outcomes required for leadership effectiveness at a given stage of company development.

In our work with venture-backed companies, we observe that the most successful investors and boards introduce scorecards early, ideally at the seed stage, to create shared clarity between founders, boards, and investors about leadership expectations. The scorecard serves multiple functions: it provides an objective basis for assessing current leadership capabilities, identifies gaps that must be addressed through complementary hires or development, and establishes the criteria for evaluating new executive talent as the company scales.

Critically, the scorecard is not static. What earns an A+ rating in pre-clinical stages may become a liability in later stages if not complemented by new competencies. A founder-scientist who excels at articulating scientific vision and managing capital planning (essential scorecard criteria for Phase I) must later demonstrate operational discipline, regulatory navigation, and commercial strategy (Phase II-III scorecard criteria) or risk becoming a bottleneck to growth.

The power of the scorecard lies in its ability to make leadership transitions proactive rather than reactive. By defining success criteria before gaps become critical, companies can coach their leadership team, make strategic hires, and manage founder transitions with transparency and minimal disruption. The scorecard transforms leadership from a subjective judgment into a measurable, manageable strategic asset.

Milestone leadership: matching talent to development stage

Biotech companies progress through particularly distinct development stages, each demanding fundamentally different leadership capabilities. The milestone leadership framework maps these transitions, showing how the leadership scorecard must be reconsidered at each critical juncture to reflect new priorities, competencies, and success metrics.

Stage I: scientific discovery (pre-clinical)

• Primary milestone: Validate the scientific hypothesis and establish proof of concept
• Critical leadership attributes: Visionary thinking, deep domain expertise, scientific storytelling, resourcefulness and capital frugality, network activation
• Leadership scorecard: At this foundational stage, the scorecard prioritizes scientific credibility and cash preservation. Leadership success is measured by the ability to articulate a compelling biological rationale that links the scientific idea to a viable market need, translate complex science for non-scientific audiences (investors, board members, advisors), and manage cash runway with discipline. Organizations maintain lean teams, often consisting of just two key roles, such as CEO and CSO, as their core leadership team. Leaders are hands-on players, essential to the execution of key tasks — not just directing the work of others.

Successful Phase I leadership teams distinguish themselves through deep domain expertise that commands credibility with scientific advisors and potential academic partners, combined with the ability to activate external networks. This networking, meaning cementing relationships with KOLs, academic partners, and early-stage investors, becomes essential for building momentum and validating the scientific approach.

Stage II: scientific validation (IND–phase I)

• Primary milestone: Achieve regulatory clearance and demonstrate initial human safety
• Critical leadership attributes: Clinical development expertise, operational planning, regulatory strategy, fiscal management, governance, and capital access.
• Leadership scorecard: As companies enter the clinic, the scorecard shifts to emphasize agility and regulatory navigation. While visionary thinking from Phase I remains essential, new competencies become critical to advancing the science from laboratory to human trials.

Clinical development expertise now takes center stage, encompassing trial design, patient recruitment strategies, and data integrity management. Leadership must demonstrate operational planning capability while establishing basic processes that bring structure without stifling the scientific innovation that fueled early success. This delicate balance — professionalizing operations while preserving entrepreneurial agility — often determines whether companies successfully navigate the IND filing and Phase I execution.

Regulatory strategy and agency engagement become non-negotiable competencies at this stage. Leadership teams must build credible relationships with regulatory authorities, anticipate potential concerns, and design development pathways that satisfy both scientific rigor and regulatory requirements.

Fiscal management emerges as a critical capability in this stage, requiring leadership to implement more robust systems to manage the increased complexity of clinical budgets, resource allocation, and cash flow planning. The introduction of governance structures and strategic access to capital sources becomes essential as companies prepare for seed and Series A fundraising rounds and establish board-level oversight.

Companies that fail to evolve their leadership competencies in conjunction with the scorecard requirements at this juncture often experience fundraising barriers and erosion in board and investor confidence, even when the underlying science remains sound.

Stage III: clinical validation (phase II)

• Primary milestone: Demonstrate clinical efficacy and prepare for commercial readiness
• Critical leadership attributes: Business development, commercial strategy, operational discipline and cross-functional coordination, financial sophistication, organizational design at scale
• Leadership scorecard: This inflection point represents the most dramatic scorecard shift, expanding criteria to include commercial integration and strategic positioning. Investors now assess whether leadership can transition from “proving the science works” to “proving the business works.”

The evolved scorecard demands business development and partnership negotiation capabilities as the first priority, followed by commercial strategy and infrastructure, and market access planning capabilities that were largely absent in earlier stages. Leadership teams must now articulate not just scientific differentiation but also competitive positioning, pricing strategy, and reimbursement pathways. Operational discipline and cross-functional coordination now become formalized and scaled as companies evaluate strategic alliances, licensing opportunities, and potential acquisition scenarios. Financial sophistication around capital allocation and optimization, pricing, and M&A distinguishes leadership teams who can create strategic paths from those who remain tactically focused. Organizational design and talent acquisition at scale test leadership’s ability to build teams that can execute on increasingly complex mandates while evolving the culture that attracted early talent.

This is where CEO transitions most frequently occur, representing arguably the most critical inflection point in a biotech company’s leadership evolution. At this juncture, more than at any other, boards and investors face a critical decision: can a founder-scientist who commanded credibility in early scientific stages evolve into a commercial leader capable of proving the business works, or must the company bring in a professional CEO with commercial expertise and capital markets credibility?

Stage IV: commercial (phase III+)

• Primary milestone: Achieve regulatory approval, launch product, and scale revenue
• Critical leadership attributes: Enterprise orchestration and change leadership, commercial execution, strategy and value creation, strategic portfolio management, culture sustenance during growth
• Leadership scorecard: The scorecard shift at this juncture prioritizes enterprise orchestration and strategic value creation. Leadership must now balance multiple constituencies — patients, payers, regulators, employees, and investors — while evolving the entrepreneurial culture that drove early success.

Commercial execution, market leadership, and revenue growth become the primary measures of leadership effectiveness. Leadership must demonstrate market traction, optimize pricing and reimbursement strategies, and scale sales operations to capture market opportunity. Strategy and value creation pathways expand beyond simple revenue growth to encompass multiple exit scenarios, whether IPO, acquisition, or strategic partnership.

Strategic portfolio management becomes essential as companies look beyond the initial product to pipeline expansion through lifecycle management, label expansion, and external innovation partnerships. Compliance and operational readiness emerge as critical competencies, requiring leadership teams to establish enterprise-grade systems for regulatory compliance, quality management, and commercial operations as the company transitions into late clinical and commercial stages.

Talent retention and culture sustenance during complexity and growth test leadership’s ability to evolve the innovation DNA and entrepreneurial spirit that fueled early success while professionalizing operations to meet the demands of a scaled enterprise. The most successful companies retain the essential attributes of prior stages, such as scientific rigor and execution discipline, while acquiring these new competencies rather than abandoning their roots.

Making milestone leadership actionable: a strategic playbook

Effective leadership transitions require proactive planning, transparent communication, and dedicated support for both incoming and outgoing leaders. From an investor perspective, a thoughtful and prepared evolution of the C-suite, aligned specifically with the company’s development roadmap, serves as a powerful signal of organizational maturity and a primary indicator of readiness for the next stage of value creation.

To ensure leadership evolution keeps pace with scientific and clinical progress, organizations should adopt a leadership playbook that emphasizes intentional leadership team construction supported by leadership assessment, structured team alignment, and ongoing development. These are the essential practices that enable biotech companies to build leadership capacity ahead of critical milestones.

• Profile evolution. As companies progress from scientific discovery to commercial scale, the competencies required of key leadership roles must evolve accordingly. There are distinct patterns in how key leadership roles evolve across the biotech lifecycle to drive success at each critical milestone.

• Strategic timing. Initiate leadership planning 12–18 months in advance of major milestones. Use this window to identify the specific competencies required for the next stage rather than solving for current gaps. This forward-looking approach prevents the reactive rushing that often derails momentum at critical junctures.

• Leadership team alignment. Establish clear decision-making cadences and collective focus areas for the executive team. As the organization scales, ensure the leadership team functions as a unified system where individual functional excellence is balanced with collective accountability for enterprise-level goals. Regular team assessments, benchmarked against stage-appropriate leadership scorecards, provide investors, boards, and leaders themselves with objective insight into whether the team has the capacity to scale with the business and where complementary hires are needed.

• Culture stewardship. Actively manage cultural evolution to preserve the bias toward urgency and innovation of the early days while building the governance and quality systems required for late-stage development. Define cultural non-negotiables, i.e., the essential attributes that new executive hires must embody to maintain the company’s innovation DNA, alignment, and collaboration. New leaders must be integrated not just for their skills, but for their ability to model and protect these core values.

The milestone leadership advantage

The biotech journey from scientific innovation to commercial success requires more than groundbreaking science. It demands leadership that evolves deliberately with each milestone. By embedding leadership scorecard and deploying leadership playbook, biotech companies transform leadership evolution from a reactive necessity into a strategic advantage — one that investors recognize, reward, and increasingly demand.

In an industry where scientific breakthroughs and leadership excellence must advance in tandem, the Milestone Leadership framework provides a roadmap for sustainable growth and value creation.

Your next milestone is approaching. Is your leadership ready?

We extend our appreciation to Jennifer Braverman, Robert Nickey, Ayesha Price, and Saule Serikova for their insights, expertise, and contributions to this article. WittKieffer is the premier executive search and leadership advisory firm developing impactful leadership teams for organizations that improve quality of life. We work exclusively with organizations in healthcare, education, and life sciences — the Quality of Life Ecosystem — providing essential knowledge, analysis, and perspective that produce effective leaders and inclusive cultures. Through our executive search, interim leadership, and leadership advisory solutions, we strengthen organizations that make the world better. WittKieffer is proud to be 100 percent employee-owned. Visit wittkieffer.com to learn more.