Sr. Manager, 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 Sr. Manager formulates endpoint measurement strategy to support approval, labeling, medical differentiation and value strategies as well as advise on technical implementation of the strategies.
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• Supports O&E, Regulatory and Clinical Colleagues in the development and design of the of Clinical Outcomes Assessment (COA) endpoint/measurement strategy
• Provides access to technical expertise in the analysis and dissemination of COA data
• 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 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 modeling One Pfizer behaviors and championing the PCOA department vision and by influencing O&E peers and leadership
• Travels for work with appropriate internal and external customers in the US and/or internationally (10% to 25% depending upon need)
• Other duties as assigned
Qualifications
PhD in Psychology, Epidemiology, Statistics, Public Health or related discipline with 5+ 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 8+ years of experience (minimum of 7 in patient-reported outcomes or clinical outcome assessment), or BA Psychology, Epidemiology, Statistics, Public Health or related discipline with 10+ years of experience (minimum of 5 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
• 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
• Excellent analytical skills and ability to draw insights/derive viable strategic options that offer opportunities to align cross-functionally
• 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
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