Director, HTA, Value & Evidence (HV&E), PCOA
Pfizer
2 months ago
Remote friendly (New York, NY)
United States
Market Access
Role Responsibilities:
- Develops and executes PCOA strategies to support therapeutic area/asset specific clinical development plans, global HV&E strategies, integrated evidence plans, and commercial strategies.
- Collaborates with cross-functional stakeholders to ensure PCOA strategies and deliverables are fit-for-purpose and aligned with program goals.
- Ensures PCOA strategies align with current regulatory and HTA guidance documents (e.g., FDA, EMA, JCA).
- Leads qualitative and quantitative evidence generation research to inform and support PCOA strategies.
- Provides technical expertise in implementation, analysis, interpretation, and communication of clinical outcome assessment (COA) data.
- Manages a global network of consultants and contract organizations to execute COA evidence generation deliverables (e.g., qualitative COA development evidence, psychometric analyses, COA qualification dossiers).
- Maintains awareness of new research methods, tools, and data sources to ensure study methods reflect the current state of science.
- Promotes the value of patient-centered outcome assessments through education and training.
Basic Qualifications:
- Advanced academic degree (e.g., MSc, MPH, PhD, DrPH, ScD, PharmD) in a relevant field such as public health, psychology, health economics, epidemiology, pharmacy administration, or other research-focused health outcomes.
- Minimum 5 years’ experience with PhD/DrPH/ScD/PharmD, or minimum 7 years’ experience with MSc/MPH in consulting, pharmaceutical industry, or academia in COA research or related health outcomes research.
- Advanced understanding of COA research methodology (qualitative and quantitative).
- Knowledge of regulatory guidance documents (FDA, EMA).
- Strong analytical and synthesis skills of qualitative and quantitative data demonstrated in scientific publications.
- Experience developing new or validating existing COA measures in multiple therapeutic areas or assets.
- Experience preparing regulatory briefing documents and COA dossiers to support COA-based labeling.
- Scientific rigor, autonomy, and initiative.
- Ability to work effectively in a fast-paced, cross-functional matrix environment and independently.
- Technical competency in systematic literature reviews and qualitative research.
- Technical competency in use of ePRO/eCOA and linguistic validation of COAs.
- Strong project management skills (multiple projects, budget planning, vendor management, competing deadlines, shifting priorities).
- Excellent interpersonal skills; ability to respond to internal/external customers and influence in a matrix environment.
- Excellent oral and written English communication skills.
Preferred Qualifications:
- Knowledge of basic elements of psychometric analysis.
- Experience leading PCOA strategy discussions during formal meetings with global regulatory agencies.
Application Instructions:
- Last Date to Apply for Job: April 21st, 2026.
Additional Job Details:
- Ability to travel domestically and internationally.
- Hybrid role requiring onsite 2 to 3 days per week.
- Develops and executes PCOA strategies to support therapeutic area/asset specific clinical development plans, global HV&E strategies, integrated evidence plans, and commercial strategies.
- Collaborates with cross-functional stakeholders to ensure PCOA strategies and deliverables are fit-for-purpose and aligned with program goals.
- Ensures PCOA strategies align with current regulatory and HTA guidance documents (e.g., FDA, EMA, JCA).
- Leads qualitative and quantitative evidence generation research to inform and support PCOA strategies.
- Provides technical expertise in implementation, analysis, interpretation, and communication of clinical outcome assessment (COA) data.
- Manages a global network of consultants and contract organizations to execute COA evidence generation deliverables (e.g., qualitative COA development evidence, psychometric analyses, COA qualification dossiers).
- Maintains awareness of new research methods, tools, and data sources to ensure study methods reflect the current state of science.
- Promotes the value of patient-centered outcome assessments through education and training.
Basic Qualifications:
- Advanced academic degree (e.g., MSc, MPH, PhD, DrPH, ScD, PharmD) in a relevant field such as public health, psychology, health economics, epidemiology, pharmacy administration, or other research-focused health outcomes.
- Minimum 5 years’ experience with PhD/DrPH/ScD/PharmD, or minimum 7 years’ experience with MSc/MPH in consulting, pharmaceutical industry, or academia in COA research or related health outcomes research.
- Advanced understanding of COA research methodology (qualitative and quantitative).
- Knowledge of regulatory guidance documents (FDA, EMA).
- Strong analytical and synthesis skills of qualitative and quantitative data demonstrated in scientific publications.
- Experience developing new or validating existing COA measures in multiple therapeutic areas or assets.
- Experience preparing regulatory briefing documents and COA dossiers to support COA-based labeling.
- Scientific rigor, autonomy, and initiative.
- Ability to work effectively in a fast-paced, cross-functional matrix environment and independently.
- Technical competency in systematic literature reviews and qualitative research.
- Technical competency in use of ePRO/eCOA and linguistic validation of COAs.
- Strong project management skills (multiple projects, budget planning, vendor management, competing deadlines, shifting priorities).
- Excellent interpersonal skills; ability to respond to internal/external customers and influence in a matrix environment.
- Excellent oral and written English communication skills.
Preferred Qualifications:
- Knowledge of basic elements of psychometric analysis.
- Experience leading PCOA strategy discussions during formal meetings with global regulatory agencies.
Application Instructions:
- Last Date to Apply for Job: April 21st, 2026.
Additional Job Details:
- Ability to travel domestically and internationally.
- Hybrid role requiring onsite 2 to 3 days per week.