Director, HTA, Value & Evidence (HV&E), PCOA
Director, HTA, Value & Evidence (HV&E), PCOA
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$ 169700 - 282900
1 Vacancy
Job Description
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 decisionmaking.
The PatientCentered 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 decisionmaking.
The PCOA Director is responsible for development and execution of fitforpurpose PCOA strategies in clinical trials and observational studies to support registration access and reimbursement for Pfizers portfolio of innovative therapies.
The PCOA Director is an integral member of the HV&E organization and serves as a critical partner to crossfunctional 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 cocreation.
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 crossfunctional stakeholders to ensure that the PCOA strategies and related deliverables are fitforpurpose 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 COAbased 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
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 researchfocused 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 COAbased labeling.
- Scientific rigor autonomy and sense of initiative.
- Demonstrated ability to work effectively in a fastpaced environment in a crossfunctional 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
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
Other Job Details:
- Last Date to Apply for Job: May 15 2025
- Ability to travel based on business needs
- NOT eligible for Relocation Package
- Position is hybrid and will require to work 2/3 days a week from site
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Director
Employment Type
Full-Time
