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Hours Full-time, Part-time
Location New York, NY
New York, New York

About this job

About Pfizer

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere.Our colleagues have the opportunity to grow and develop a career that offers both individual and company success;be part of an ownership culture that values diversity and where all colleagues are energized and engaged;and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry,is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description

Director, Patient-Centered Outcomes Assessment (PCOA) is committed to representing patients and the people who care for and about them by serving as an endpoints measurement expert and advisor to Outcomes and Evidence (O&E), Regulatory and Clinical Colleagues across the Pfizer portfolio Drug Development Programs or Therapeutic Areas. In collaboration with the O&E Lead, the PCOA Director formulates endpoint measurement to support approval, labeling, medical differentiation and value strategies as well as advises on technical implementation of the strategies.

Responsibilities

* Supports O&E, Regulatory and Clinical Colleagues in the development and design of the of Clinical Outcomes Assessment (COA) endpoint/measurement strategy

* Provides technical expertise in the analysis and dissemination of COA data

* Ensures the scientific quality and integrity of all COA strategies to which you contribute either as a lead or as an advisor

* Communicates & collaborates effectively both internally and externally to ensure that the COA strategy and deliverables are of value and align with overall program goals

* Triages concerns and proactively engages the appropriate colleagues/team members to ensure that their ideas are explored and respect is given to their professional expertise and experience

* Contributes to, advises on briefing packages and may participate at Regulatory interactions to ensure that COA strategies are acceptable and compliant with Regulatory guidance

* Identifies, evaluates, retains and oversees a global network of consultants and contract organizations to execute the PCOA evidence generation deliverables (e.g. qualitative COA development evidence, psychometric analyses, COA qualification dossiers, etc.)

* Maintains awareness of new methods, tools and data sources to ensure study methods represent current state of the science

* Helps develop the PCOA and O&E Department Function by mentoring and teaching staff and by influencing O&E Leadership

* Travels to work with appropriate internal and external customers in the US and/or internationally

* Other duties as assigned

Organizational Relationships

* Global Health and Value

* Regulatory Affairs

* Research and Development

* Commercial

* Medical Affairs

* Clinical Research

Financial Accountability

* Responsible for PCOA project budget projections, management and reporting. May have responsibility for management of a Therapy Area budget.

Qualifications

Education:

PhD in Psychology, Epidemiology, Statistics, Public Health or related discipline with 9+ years of experience (minimum of 3 in patient-reported outcomes or clinical outcome assessment), or, MA Psychology, Epidemiology, Statistics, Public Health or related discipline with 12+ years of experience (minimum of 2 in patient-reported outcomes or clinical outcome assessment), or BA Psychology, Epidemiology, Statistics, Public Health or related discipline with 14+ years of experience (minimum of 7 in patient-reported outcomes or clinical outcome assessment).

Skills and Competencies:

Minimum

* Understanding of global drug development, outcomes research and COA instrument development and the methods addressed in the FDA PRO Guidance

* Experience in evaluating and developing COA instruments for inclusion in clinical studies that meet regulatory agency standards for label claims

* Excellent analytical skills and ability to draw insights/derive viable strategic options that offer opportunities to align cross-functionally

* Technical compentency in systematic reviews and qualitative research

* Self motivated and able to work independently

* Strong process/project management skills

Desired

* 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

* Knowledge of the disease areas within the Therapeutic Area

* Ability to translate analytic skill into strategic vision of relevance to internal and external stakeholders

* Technical competency in psychometrics, or statistics

* Technical competency in use of ePRO/eCOA and linguistic validation of COAs

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.