Director – HTA Value & Evidence – Hv&E – Pcoa
| Company | Pfizer |
|---|---|
| Location | San Francisco, CA, USA, Tampa, FL, USA, Bothell, WA, USA, Phoenixville, PA, USA, Memphis, TN, USA, La Jolla, San Diego, CA, USA, Highland Park, IL, USA, New York, NY, USA, Sanford, NC, USA |
| Salary | $169700 – $282900 |
| Type | Full-Time |
| Degrees | Master’s, MBA, PharmD, PhD |
| Experience Level | Senior |
Requirements
- Advanced academic degree required (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.
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 to cross functional colleagues.
- Prepares regulatory briefing documents and COA dossiers to support COA-based labeling.
- Leads scientific publication strategy focused on qualitative and quantitative 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 PCOA across Pfizer enterprise.
Preferred Qualifications
- Knowledge of basic elements of psychometric analysis
- Leading PCOA strategy discussions during formal meetings with global regulatory agencies
- Knowledge and experience in Oncology