Pfizer Patient in New York, New York
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.
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
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:
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
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.
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.
Additional Offer Details:
• Last Date to Apply for Job: March 26, 2018
• Eligible for Employee Referral Bonus
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.