Patient-Centered Outcomes Assessment, Director

Employer
Pfizer
Location
Cambridge, MA
Posted
May 16, 2022
Ref
4846322
Required Education
Masters Degree/MBA
Position Type
Full time

Role Summary

The Patient-Centered Outcomes Assessment (PCOA) Director, will support the Value & Evidence PCOA Lead.

The incumbent will drive PCOA strategies for Pfizer’s portfolio of Innovative therapies by representing patients’ perspective and preferences (as well as caregivers and clinicians) and ensuring a single and coordinated view on PCOA strategy and delivery from PHI to the enterprise.

She/he will provide subject matter expertise (SME) in COA strategy, development, and implementation across Pfizer portfolio to support drug approval, labeling, medical differentiation, and value strategies.

She/he will lead the development and technical execution of PCOA and clinical outcome assessment (COA) strategies in the clinical trials and observational studies to optimize regulatory, HTA, and market access outcomes for Pfizer’s innovative therapies.

The PCOA director will be integral member of the Patient and Health Impact (PHI) Value & Evidence teams, Value & Access teams, support integrated value & access strategies (IVAS), integrated value & evidence plans (IVEP), as well as a serve as a critical partner to cross-functional stakeholders in GPD, WRDM, medical affairs, real-world evidence, and commercial at every stage of development and reimbursement. As a PCOA SME, she/he will foster a team culture of collaborative sharing of knowledge and co-creation.

ROLE RESPONSIBILITIES

  • Develops and leads PCOA/COA strategies to support therapeutic area /asset specific clinical development plans, IVAS, IVEP, and medical affairs tactics.
  • Effectively collaborates with cross-functional stakeholders to ensure that the PCOA/COA strategies and deliverables are fit for purpose and aligned with the overall program goals
  • Ensures that COA strategies are acceptable and compliant with regulatory guidance (FDA, EMA)
  • Conducts qualitative and quantitative research to inform COA development
  • In collaboration with PHI and R&D colleagues, develops and disseminates COA endpoint/measurement strategy
  • Provides technical expertise in the analysis, interpretation, and communication of COA data
  • Effectively collaborates with cross-functional stakeholders to ensure that the COA strategy and deliverables are fit for purpose and aligned with the overall program goals
  • Ensures that COA strategies are acceptable and compliant with regulatory guidance (FDA, EMA)
  • 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, etc.)
  • 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.
  • Travels for work with appropriate internal and external customers in the US and/or internationally (10% to 25% depending upon need)

BASIC QUALIFICATIONS

Education:

• Relevant advanced academic degree (e.g., doctorate or master’s degree in psychology, health economics, public health, epidemiology) with 9+ years (master’s degree) or 7+ years (doctorate degree) of consulting, pharmaceutical industry, or academia experience and at least 5 years of consulting or industry experience in COA development, with demonstrated track record of leading regulatory engagement on COA strategies.

  • Graduate degree (i.e., MSc or PhD) and 7+ years of experience in HEOR or relevant related fields (i.e., health economics, epidemiology, health services research, or other research-focused public health field) or equivalent experience

  • 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.

Required skills and competencies:

  • Knowledge of the drug development process.
  • Strong analytical and synthesis skills of qualitative and quantitative data.
  • Understanding of COA research methodology and regulatory (FDA, EMA) environment
  • Scientific rigor, autonomy, and sense of initiative.
  • Good interpersonal and communication skills, both written and oral; ability to understand and communicate with cross-functional stakeholders
  • Ability to manage multiple priorities and projects, and balance workload and timelines; Able to work in a fast-paced and dynamic environment.
  • Ability to work effectively either in small teams or independently.
  • Proven track record in COA disciplines including development of new COA, data analyses, scientific publication & input to clinical trials.
  • Technical compentency in systematic literature reviews and qualitative research
  • Experience preparing regulatory briefing documents and dossiers to support negotiations for COAs to support labeling
  • Experience presenting and negotiating COA measurment strategies with global regulatory agencies
  • Technical competency in psychometrics or statistics
  • Technical competency in use of ePRO/eCOA and linguistic validation of COAs
  • Strong project management skills


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.

PHYSICAL/MENTAL REQUIREMENTS

N/A

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

N/A

Other Job Details:



Last Date to Apply for Job:04/29/2022
NO Relocation Package
Eligible for Employee Referral Bonus

#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.

Market Access