Building Medical Affairs for a First Launch
A late-stage biotech preparing for pivotal Phase 3 trials faced the challenge of designing and building its first Medical Affairs function. With a newly hired VP of Medical Affairs, the company needed to define the function’s value proposition, win organizational support, and begin executing priority tactics—all under the pressure of budget season and looming commercialization needs. Working side-by-side, we helped craft strategy, align stakeholders, build the team, and establish disciplined execution routines. The outcome: Medical Affairs became a recognized strategic partner, contributed directly to launch readiness, and factored into the company’s $2.6B acquisition.
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Late-stage biotech in aesthetic dermatology, advancing a novel biologic for moderate chin fat.
Preparing for Phase 3 pivotal trials and first commercialization.
CEO and leadership team largely from big biotech backgrounds - strong leaders and entrepreneurs.
Highly competent executives and leaders of clinical, regulatory, supply chain, and commercial but commercialization planning just starting.
VP of Medical Affairs combined deep scientific expertise with strong business and commercial instincts.
One of the best, aware, cohesive teams we’ve worked with.
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Build Medical Affairs from scratch to bridge the company from R&D into a commercial enterprise.
Clearly articulate Medical Affairs’ value proposition—making it measurable, accountable, and aligned with executive priorities.
Provide bandwidth and structure for the VP, who was juggling science, publications, and strategic planning.
Ensure Medical Affairs strategy tied directly to executive and board priorities while building organizational processes and team capacity.
Ensure VP and the team we built operated in their Upper 50% - the activities each individual was uniquely positioned to perform that produced the most value to the organization and its mission.
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Constant onboarding of new employees required repeated education and alignment on Medical Affairs’ role.
Tight headcount and budget pressures during LRP/LE season.
Lack of existing infrastructure or benchmarks for a novel, first-in-class product.
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Facilitated a two-day offsite with the VP to download priorities, develop a roadmap, and draft the first Medical Affairs budget.
Created a strategy deck articulating the function’s outcomes-based value proposition—iterated through 20+ versions to secure executive and board alignment.
Transitioned quickly from planning to execution: developing medical content, publications, and the Patient Success Journey model with early commercial input.
Operated as Chief of Staff to the VP: onboarding new leaders, earning trust, and integrating them into the strategy.
Established a disciplined rhythm: weekly leadership meetings around an 800-line project plan, enabling collaboration, problem-solving, and agility.
Supported operational build-out, including vendor selection, real-world evidence program business case, and reporting solutions.
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Medical Affairs was recognized as a strategic, accountable partner with measurable impact.
Gained board visibility and secured increased MSL headcount based on clearly defined outcomes.
Helped shape organizational alignment between Medical and Commercial, preventing duplication and fostering compliant collaboration.
Patient Success Journey became a cornerstone model for planning and execution.
Company was acquired by Allergan for $2.6B, with Medical Affairs’ strategy and systems incorporated into Allergan standards post-acquisition.
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Patient Success Journey model
Medical Affairs Fishbone framework
Early innovation: SC Insight reporting against defined value proposition
Medical Affairs build project plan (Excel)
Disciplined cadence of weekly leadership meetings and offsites