Evidence Lead for Clinical-Stage Combination Therapy
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Client needed an evidence lead to support a clinical-stage combination therapy through key early development
milestones.
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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.
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Served as evidence lead for the program, owning development of the Q-Sub, protocol, and clinical evidence
strategy.
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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.
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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.
