Physician-scientist. Fractional Chief Medical Officer. Senior clinical-development advisor for high-risk programs where design, evidence and execution must hold under scrutiny.
Executive profile
Manolo has designed, led or advised more than 100 studies across Phase I-IV, post-authorisation safety studies, epidemiology and HEOR in pharma, biotech, CRO and academic settings. His work integrates clinical strategy, medical leadership, regulatory interaction, pivotal design, rescue, Medical Affairs, market access, due diligence and global execution.
Where he creates value
Development thesis, indication and population choice, target product profile, evidence gaps and decision gates.
Endpoint, estimand, comparator, duration, sample-size and operational choices that protect interpretability.
Feasibility, country and site logic, vendors, RBQM, governance, escalation and recovery.
Integrated evidence planning across FDA, EMA, HTA, HEOR and future adoption.
Independent clinical risk maps, financing gates and development plans that can withstand diligence.
Scientific narrative, evidence strategy, external intelligence and insight-to-action governance.
Selected impact
Examples are representative and anonymized. Outcomes depend on program context, sponsor readiness and the authority granted to the mandate.
Focus
Deep concentration in CNS, neurology, sleep medicine, psychiatry, rare disease and complex endpoints, with cross-therapeutic experience including oncology, immunology and ophthalmology.
Operating philosophy
The job is not to make uncertainty disappear. It is to identify which uncertainty matters, design evidence that can resolve it and govern execution so the answer remains interpretable.
A decision-grade next step
A focused first conversation can establish whether the decision, timing and mandate fit.
