Director, Patient-Centered Research, HEOR

Who we are:

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.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Director of Patient-Centered Research to join our growing Health Economics and Outcomes Research (HEOR) team. We want someone who cares deeply about this important work, and who’s driven to connect to our mission of helping these patient communities. The individual in this role will be responsible for playing an integral role in the approval and commercialization activities of our expanding GDD portfolio.

What you will do:

The broader HEOR team at Agios is responsible for three pillars of activities:

• 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);
• Market access support (e.g. cost-effectiveness and budget impact modeling, AMCP and global value dossiers, HTA submissions, etc.); and,
• Clinical development program support (e.g. patient-reported outcomes strategies for clinical trials).
  
  

The successful candidate for this role will be largely focused on clinical development program support and patient-sourced real-world evidence generation activities. They are expected to have deep expertise in clinical outcomes assessment (COA) strategy and analysis for regulatory filings, considerable experience engaging with regulatory agencies (written and oral communications), and strong quantitative and qualitative research skills.

This individual 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 Vice President of HEOR and Data Science Analytics.

Responsibilities Will Include, But Are Not Limited To, The Following

• 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.
  
  

What you bring:

• 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
  
  

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• 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 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. 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.
  
  

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.