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About the role
- PCOA Director leading development of PCOA strategies for Pfizer’s clinical trials and studies. Collaborating with cross-functional teams and ensuring alignment with regulatory guidance.
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
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 and an additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
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