Evidence lead · clinical-stage combination therapy

Situation

Client needed an evidence lead to support a clinical-stage combination therapy through key early development milestones.
Program required an integrated evidence strategy spanning Q-Sub development, protocol authoring, and overall clinical evidence planning.
The asset was part of a partnership, requiring alignment across both internal and partner organizations.

Served as evidence lead for the program, owning development of the Q-Sub, protocol, and clinical evidence strategy.
Balanced competing priorities to manage cross-functional inputs across manufacturing, medical, safety/PV, biostats, and other stakeholders.
Design a SoA that minimized patient burden & cost while preserving rigor.
Coordinated with the partner organization to incorporate external inputs and align on evidence requirements for the combo therapy.

Advanced a cohesive, cross-functional evidence strategy for a complex clinical-stage asset.
Enabled alignment across internal teams and partner stakeholders on protocol and evidence priorities.
Supported a more efficient study design that balanced operational feasibility, patient experience, and scientific robustness.