Director, HTA, Value & Evidence, PCOA

Role Overview

• Develops and executes PCOA strategies to support therapeutic area/asset specific clinical development plans, global HV&E strategies, integrated evidence plans, and commercial strategies.
• Effectively collaborates with cross-functional stakeholders to ensure that the PCOA strategies and related deliverables are fit-for-purpose and aligned with the overall program goals.
• Ensures that PCOA strategies are aligned with the most 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 the implementation, analysis, interpretation, and communication of clinical outcome assessment (COA) data.
• Manages a global network of consultants and contract organizations to execute the 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 represent current state of the science.
• Promotes the value of patient-centered outcome assessments across Pfizer through education and training.

Requirements

• Advanced academic degree (e.g., MSc, MPH, PhD, DrPH, ScD, PharmD) in relevant field such as, public health, psychology, health economics, epidemiology, pharmacy administration, or other research-focused health outcomes field.
• Minimum 5 years of experience with PhD/DrPH/ScD/PharmD or minimum of 7 years of 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 methodology)
• Knowledge of regulatory guidance documents (FDA, EMA)
• Strong analytical and synthesis skills of qualitative and quantitative data demonstrated in scientific publications
• Experience with 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 sense of initiative.
• Demonstrated ability to work effectively in a fast-paced environment, in a cross-functional, matrix team setting as well as independently.
• Technical competency in systematic literature reviews and qualitative research.
• Technical competency in use of ePRO/eCOA and linguistic validation of COAs.
• Demonstrated strong project management skills (ability to manage multiple projects budget planning, vendor management, managing competing deadlines and rapidly shifting priorities)
• Excellent interpersonal skills required; ability to understand and respond to multiple internal and external customers and influence in a matrix environment
• Excellent oral and written English communication skills required

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation
• Holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental, and vision coverage