ROLE SUMMARY

As a leading biopharmaceutical company, Pfizer is dedicated to the discovery and delivery of high value therapies across a variety of disease areas. It is our mission to bring innovative medicines to patients that significantly improve their lives, and our priority is to ensure patients have access to these medicines. The Health Technology Assessment (HTA), Value & Evidence (HV&E) team is responsible for ensuring patients have affordable, timely access to medicines and vaccines by advancing innovative value and evidence solutions — to inform healthcare decision-making.

The Patient-Centered Outcomes Assessment (PCOA) team is part of HV&E and is responsible for ensuring that patient experience data are adequately captured in Pfizer clinical development programs to be deemed as valid scientific evidence supporting registration, access, and healthcare decision-making.

The PCOA Director is responsible for development and execution of fit-for-purpose PCOA strategies in clinical trials and observational studies to support registration, access, and reimbursement for Pfizer’s portfolio of innovative therapies. The PCOA Director is an integral member of the HV&E organization and serves as a critical partner to cross-functional stakeholders in R&D, CMO, RWE, and Commercial organizations. As PCOA subject matter expert, the Director fosters a team culture of collaborative knowledge sharing and co-creation.

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.
• 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.

BASIC QUALIFICATIONS

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
• 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.