Associate Director, Patient-Centered Research

Associate Director, Patient-Centered Research

At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate.

Our team's proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it's deeply personal, grounded in the meaningful connections we have built.

Agios Pharmaceuticals is searching for a dynamic Associate Director, Patient Centered Research to join our growing HEOR team who will lead Patient-Centered Research activities across all GDD programs, including but not limited to pyruvate kinase deficiency, thalassemia, and sickle cell disease.

The HEOR team at Agios focuses on three pillars of activities:

• Clinical development program support (e.g. patient-reported outcomes [PRO] strategies for clinical trials);
• Real-world evidence generation (e.g. studies of natural history, burden of illness, treatment patterns, etc. using a variety of data sources including EMR, claims data, registries, chart reviews, and qualitative research); and,
• Market access support (e.g. cost-effectiveness and budget impact modeling, AMCP and global value dossiers).

We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Associate Director, HEOR will be largely focused on clinical development program support and PRO-related activities. They are expected to have expertise in clinical outcomes assessment (COA) strategy, PRO analysis and strong qualitative research skills. In addition, experience with application of PRO data to regulatory, health economic and access activities is expected.

They will be accountable for designing and conducting superior quality research that is medically relevant, scientifically valid, and aligned with the evidence generation and communication needs of our programs. This role will report to the Senior Director of Patient Centered Research within Global Medical Affairs.

Design and execution of quantitative and qualitative research (including PROs, preference studies, patient interviews, etc) to incorporate patient perspectives into clinical research and real-world evidence studies across the product lifecycle to support regulatory approval, product labeling, value demonstration, and market access activities;

Understanding patient insights and experiences with disease and treatment, through the measurement of outcomes that matter most to patients, including symptoms of disease, effects of treatment, and their impact on how patients feel and function;

Execution of gap analyses, patient interviews, and/or reviews of the literature and PRO labels, to select and/or develop appropriate patient-reported measures or other COAs for clinical trials in accordance with FDA and EMA guidance;

Collaboration with cross-functional partners on COA endpoint strategy;

Leading the preparation of the COA components of regulatory briefing books, clinical trial protocols, statistical analysis plans, clinical study reports, regulatory filing documents, and HTA submissions;

Collaboration with study statisticians on the analysis and interpretation of COA data, including assessments of clinically meaningful change;

Development and execution of publication plans (abstract, posters, and manuscripts) and preparation of internal and external-facing presentations of patient-centered research findings;

Ad hoc support of HEOR indication leads with real-word evidence generation activities such as natural history, burden of illness, treatment patterns, or other outcomes research studies;

Management of relationships and budgets with vendors to ensure timely completion of high quality projects;

Building strong relationships with internal partners…