Executive profile
Nearly three decades across medicine and drug development
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
At the decisions that compound
Development architecture
Development thesis, indication and population choice, target product profile, evidence gaps and decision gates.
Pivotal design
Endpoint, estimand, comparator, duration, sample-size and operational choices that protect interpretability.
Execution control
Feasibility, country and site logic, vendors, RBQM, governance, escalation and recovery.
Regulatory and payer alignment
Integrated evidence planning across FDA, EMA, HTA, HEOR and future adoption.
Board and investor decisions
Independent clinical risk maps, financing gates and development plans that can withstand diligence.
Medical Affairs
Scientific narrative, evidence strategy, external intelligence and insight-to-action governance.
Selected impact
From diagnosis to a governed path
Examples are representative and anonymized. Outcomes depend on program context, sponsor readiness and the authority granted to the mandate.
- Phase II/III rescue through recalibrated feasibility, country and site strategy, startup and recruitment cadence and risk-based quality management.
- Pivotal architecture aligning endpoint and estimand choices with regulatory, HTA and operational requirements.
- Board-ready clinical risk maps connecting technical uncertainty to time, capital and value-inflection decisions.
- In one selected multi-country CNS program, rolling enrollment forecast error improved from approximately 45% to approximately 12%.
Focus
Therapeutic depth and mandate types
Deep concentration in CNS, neurology, sleep medicine, psychiatry, rare disease and complex endpoints, with cross-therapeutic experience including oncology, immunology and ophthalmology.
- Fractional or interim CMO leadership
- Independent board and investor advice
- Clinical development plans and pivotal trial design
- Trial rescue and execution governance
- Regulatory, HTA and evidence strategy
- Medical Affairs strategy and operating-model redesign
Operating philosophy
Cleaner protocols. Fewer fantasies. Decisions that hold.
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
Put senior judgment where the program is most exposed.
A focused first conversation can establish whether the decision, timing and mandate fit.
