Director/Senior Director, Patient-Centered Outcomes

Overview / About us

Lumanity is dedicated to improving health outcomes by accelerating and optimizing access to life-changing medicines. As a global strategic partner that brings together strategy, evidence, engagement, and technology, we were designed to engineer breakthrough value to tackle our clients’ toughest challenges by revolutionizing how value is generated, demonstrated, and communicated.

Responsibilities / Position overview

The Director/Senior Director provides strategic and scientific leadership for patient-centered outcomes (PCO) engagements, ensuring research design, execution, and evidence packages are fit-for-purpose for client decision-making and regulatory use. This role is accountable for leading clinical outcome assessment (COA) projects (for example, literature reviews, gap analyses, COA development and modification, in-trial interviews, regulatory strategy, and dossier development) while maintaining high scientific quality across deliverables. The Director also owns client relationships and drives business through sales and revenue generation.

Essential Duties/Responsibilities

• Strategic & Scientific Leadership: Defines the scientific approach for PCO engagements by translating client objectives into tailored research designs and evidence-generation plans aligned with regulatory guidance, evidentiary standards, and the client’s strategic objectives.
• Endpoint & Regulatory Strategy: Develops endpoint and regulatory strategies for COA evidence packages supporting labeling claims, grounded in regulatory guidance, precedent, and emerging trends.
• Study Oversight & Technical Direction: Leads teams by defining the methodological approach, confirming data requirements, and ensuring deliverables address the research questions across project types.
• Quality & Scientific Integrity: Conducts senior-level review of analyses, data interpretations, and client deliverables to ensure they meet scientifi