Associate Director, HEOR, Patient-Centered Research

Agios Pharmaceuticals Inc • Cambridge, MA

2d • Remote

About The Position

At Agios, we are fueled by connections to transform rare diseases, fostering an inclusive, collaborative culture that sparks bold thinking and strengthens connections with rare disease communities. The company embraces diverse backgrounds with respect, active listening, and a commitment to inclusion, which shapes their hiring, collaboration, and innovation. Their team's executional excellence, expertise, and dedication enable them to develop innovative medicines reflecting the priorities of rare disease communities. Agios Pharmaceuticals is seeking an Associate Director, HEOR, Patient-Centered Research to lead Patient-Centered Research activities across all GDD programs, including pyruvate kinase deficiency, thalassemia, and sickle cell disease. The HEOR team focuses on clinical development program support (e.g., PRO strategies for clinical trials), real-world evidence generation (e.g., studies of natural history, burden of illness, treatment patterns), and market access support (e.g., cost-effectiveness and budget impact modeling). This role will primarily focus on clinical development program support and PRO-related real-world evidence generation, requiring expertise in clinical outcomes assessment (COA) strategy and analysis (including PROs) and strong qualitative research skills. The Associate Director will be accountable for designing and conducting superior quality research that is medically relevant, scientifically valid, and aligned with program evidence generation and communication needs. This position reports to the Senior Director of Health Economics & Outcomes Research within Global Medical Affairs.

Requirements

• Master’s or doctoral degree in health services research, sociology, psychology, psychometrics, public health, or related field
• At least 7 years of pharmaceutical/biotechnology industry, consulting, or academic experience, at least 5 years of which has been specifically focused on patient-centered research
• Demonstrated technical and strategic excellence in designing, conducting, and interpreting quantitative and qualitative patient-centered research
• Knowledge of the drug development process, PRO label claims, and regulatory guidance as it relates to patient-centered research, including the FDA’s patient-focused drug development (PFDD) initiative
• Strong knowledge of the process for developing and validating outcome measures, methods for determination of clinically meaningful change thresholds, and clinical trial endpoint strategy
• Ability to lead multiple projects simultaneously across a variety of therapeutic areas
• Excellent written and oral communication skills
• Strong interpersonal skills and ability to collaborate on cross-functional teams
• Ability to interface with multiple external stakeholders, including patients, caregivers, clinicians, regulators, and payers
• Ability to navigate ambiguous, complex, and difficult situations
• Ability to travel approximately 10% of the time

Responsibilities

• 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 and ensuring continuous and consistent communication regarding HEOR projects
• Compliance with all applicable laws, Agios policies, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners

Benefits

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1-10 employees