Director, HTA Value & Evidence (HV&E), PCOA

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 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

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 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

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: July 4th
• Ability to travel based on business needs (25%)
• NOT eligible for Relocation Package
• This position is hybrid and requires working onsite 2 to 3 days per week

The annual base salary for this position ranges from $169 700,00 to $282 900,00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20,0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
* The annual base salary for this position in Tampa, FL ranges from $152 700,00 to $254 500,00.
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 provider's 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 E-Verify employer. This position requires permanent work authorization in the United States.
Market Access