Director, Patient-Centered Research, HEOR

Agios Pharmaceuticals • Cambridge, MA

299d • Remote

About The Position

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases - and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company's leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

Requirements

• Master's or doctoral degree in health services research, sociology, psychology, psychometrics, public health, or related field.
• A minimum of 10 years of pharmaceutical/biotechnology industry, consulting, or academic experience, at least 8 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.
• Experience working in rare diseases (preferred but not required).
• Ability to travel approximately 10%-15% of the time.

Responsibilities

• Design and execution of quantitative and qualitative research (including PRO measurement assessment, patient interviews, surveys, 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, responses to agency queries, 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.
• 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 performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• 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.
• Commitment to community. We're an active participant in the communities that surround us.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree