Associate Director, HEOR, Patient-Centered Research
Kinsley Power Systems, Cambridge, MA, United States
Associate Director, HEOR, Patient-Centered Research
Responsibilities
Design and execute quantitative and qualitative research (including PROs, preference studies, patient interviews) to incorporate patient perspectives into clinical research and real‑world evidence studies across the product lifecycle, supporting regulatory approval, product labeling, value demonstration, and market access activities.
Understand patient insights and experiences with disease and treatment, measuring outcomes that matter most to patients, including symptoms, effects of treatment, and impact on how patients feel and function.
Execute gap analyses, patient interviews, or reviews of literature and PRO labels to select and develop appropriate patient‑reported measures or other COAs for clinical trials in accordance with FDA and EMA guidance.
Collaborate with cross‑functional partners on COA endpoint strategy.
Lead 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.
Collaborate with study statisticians on analysis and interpretation of COA data, including assessments of clinically meaningful change.
Develop and execute publication plans (abstracts, posters, manuscripts) and prepare internal and external presentations of patient‑centered research findings.
Provide ad hoc support of HEOR indication leads with real‑world evidence generation activities such as natural history, burden of illness, treatment patterns and other outcomes research studies.
Manage relationships and budgets with vendors to ensure timely completion of high‑quality projects.
Build strong relationships with internal partners and ensure continuous and consistent communication regarding HEOR projects.
Ensure 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.
Qualifications
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, of which at least 5 years have 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 related to patient‑centered research, including the FDA’s patient‑focused drug development initiative.
Strong knowledge of the process for developing and validating outcome measures, determining 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.
Location
Location Agnostic: Work location for this role is based on the employee’s individual preference. The role can be either remote in the US or hybrid at our Cambridge Headquarters. Hybrid schedules generally involve less than three 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 or meetings. Travel may be required for certain company events commensurate with the job description.
Benefits
Deliberate Development – Your professional growth is a top priority.
Flexibility – We embrace individual needs, work styles, health and wellness and care of families.
Premium benefits package – Comprehensive health, wellness and security benefits. For more detail, visit Inside Agios.
Competitive and equitable performance‑based compensation – Base salary and short‑ and long‑term incentives tied to business performance.
Psychological safety – A supportive environment encouraging idea sharing and data‑informed risk‑taking.
Commitment to diversity – Fostering a welcoming workplace where everyone can thrive.
Commitment to community – Active participation in surrounding communities and patient support.
#J-18808-Ljbffr
Responsibilities
Design and execute quantitative and qualitative research (including PROs, preference studies, patient interviews) to incorporate patient perspectives into clinical research and real‑world evidence studies across the product lifecycle, supporting regulatory approval, product labeling, value demonstration, and market access activities.
Understand patient insights and experiences with disease and treatment, measuring outcomes that matter most to patients, including symptoms, effects of treatment, and impact on how patients feel and function.
Execute gap analyses, patient interviews, or reviews of literature and PRO labels to select and develop appropriate patient‑reported measures or other COAs for clinical trials in accordance with FDA and EMA guidance.
Collaborate with cross‑functional partners on COA endpoint strategy.
Lead 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.
Collaborate with study statisticians on analysis and interpretation of COA data, including assessments of clinically meaningful change.
Develop and execute publication plans (abstracts, posters, manuscripts) and prepare internal and external presentations of patient‑centered research findings.
Provide ad hoc support of HEOR indication leads with real‑world evidence generation activities such as natural history, burden of illness, treatment patterns and other outcomes research studies.
Manage relationships and budgets with vendors to ensure timely completion of high‑quality projects.
Build strong relationships with internal partners and ensure continuous and consistent communication regarding HEOR projects.
Ensure 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.
Qualifications
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, of which at least 5 years have 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 related to patient‑centered research, including the FDA’s patient‑focused drug development initiative.
Strong knowledge of the process for developing and validating outcome measures, determining 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.
Location
Location Agnostic: Work location for this role is based on the employee’s individual preference. The role can be either remote in the US or hybrid at our Cambridge Headquarters. Hybrid schedules generally involve less than three 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 or meetings. Travel may be required for certain company events commensurate with the job description.
Benefits
Deliberate Development – Your professional growth is a top priority.
Flexibility – We embrace individual needs, work styles, health and wellness and care of families.
Premium benefits package – Comprehensive health, wellness and security benefits. For more detail, visit Inside Agios.
Competitive and equitable performance‑based compensation – Base salary and short‑ and long‑term incentives tied to business performance.
Psychological safety – A supportive environment encouraging idea sharing and data‑informed risk‑taking.
Commitment to diversity – Fostering a welcoming workplace where everyone can thrive.
Commitment to community – Active participation in surrounding communities and patient support.
#J-18808-Ljbffr