Chief Medical Officer
Oncology Biotech – USA
The Brief
A clinical-stage biotech advancing novel oncology therapeutics required a Chief Medical Officer to lead its clinical development strategy and regulatory engagement. The CEO was seeking a leader with deep experience in early-phase oncology trials, established relationships with the FDA, and the ability to integrate medical affairs into a cohesive corporate strategy. The role carried board-level visibility and was considered critical to the company’s ability to progress from preclinical promise to clinical execution.
The Challenge
The business faced ambitious timelines, with two IND submissions planned within a 12-month window. This created a pressing need for a leader who could combine scientific and clinical expertise with operational pragmatism. The ideal candidate needed credibility with leading investigators to support trial recruitment, as well as the presence to engage investors during fundraising discussions. Equally, the CMO would be expected to provide hands-on oversight of protocol design and trial execution in a resource-constrained environment, while building a scalable clinical operations function capable of supporting long-term growth. Finding an executive who could span scientific depth, regulatory know-how, and entrepreneurial agility narrowed the available pool considerably.
Our Approach
We mapped oncology CMOs and senior clinical development leaders across both biotech and large pharma who had advanced first-in-class oncology programs. Evaluation criteria included regulatory track record with early-phase trials, therapeutic breadth across solid and liquid tumors, and proven ability to lead IND-enabling studies through to clinical initiation. Beyond technical qualifications, we assessed each candidate’s experience in shaping corporate strategy and their capacity to operate effectively at board level. Outreach was targeted to individuals with demonstrated ability to build clinical infrastructures while maintaining direct involvement in trial execution, ensuring that shortlisted candidates were capable of balancing strategy with hands-on delivery.
Outcome
The appointed Chief Medical Officer had previously guided oncology programs through FDA approval and brought an established reputation with investigators and regulators. Since joining, the new leader has played a central role in protocol design, regulatory submissions, and strategic communication with the FDA. The company has initiated its first US trial on schedule and successfully secured follow-on investment, with the board crediting the appointment as a turning point in investor confidence. The hire provided the organisation with the clinical and regulatory leadership required to transform scientific promise into a viable therapeutic pipeline.
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