Patient - Centered Outcomes Assessment Lead

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 02/22/18
Collegeville, PA
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 02/22/18

PHI offers colleagues a distinct opportunity to support evidence-generation and market access strategies across Pfizer’s entire portfolio through all lifecycle stages – from early pipeline to marketed brands to loss of exclusivity and switch to over the counter. Colleagues in PHI have an unparalleled opportunity to grow and develop, while making a meaningful contribution to patient and population health around the world.

This position reports directly to the Head, Patient-Centered Outcomes Assessment (PCOA) Center of Excellence. The PCOA Senior Director (PCOA SD) is committed to representing patients and the people who care for and about them by serving as an endpoints measurement expert and advisor to Health Economics Outcomes Research (HEOR), Regulatory, Commercial and Clinical Colleagues across the Pfizer portfolio of Drug Development Programs.  The PCOA SD will be primarily responsible for leading a small team of PCOA scientists to develop, deliver and communicate the PCOA endpoint and measurement strategy in support of asset approval, labeling, medical differentiation and value as well as advise on technical implementation of the strategies to support the global Pfizer research and business objectives. The PCOA SD will provide oversight and leadership for the team by helping to set strategy and direction for Pfizer assets in collaboration with other functions within P&HI and the research unit (RU) & business unit (BU) Cross Functional Teams. Specifically, the PCOA SD will help the PCOA Head maintain functional excellence, study planning and execution, talent attraction, mentoring and development, and resource allocation. The PCOA SD will also likely lead their own projects as well as providing oversight and guidance to their reports.  The PCOA SD will function with a One PHI mindset and will work in a closely aligned fashion with the PHI Centers of Excellence Leadership Team as well as with the BU Cross-Functional Leadership Team (CFLT) members to ensure there is a single and coordinated view on strategy and delivery for PHI to Pfizer business partners.  The Senior Director also leads within PHI by influencing internal stakeholders within Pfizer, and by assuming a leadership role in the continued development of the discipline.

Provide strategic leadership for development and execution of effective PCOA strategy in collaboration with other PHI team members as well as commercial, regulatory, medical and other Pfizer colleagues.

Direct their own projects as well as lead and supervise a team of PCOA staff, particularly in the tasks listed below:

  • Generation of study proposals and designs
  • Analysis, communication, and publishing of impactful research to support the value proposition
  • Alignment of PCOA activities with the HEOR & market access strategy
  • Assessment and interpretation of relevant literature, communication to internal stakeholders
  • Contribution to the scientific literature in the form of manuscripts and publications when appropriate
  • Support of HEOR, Regulatory and Clinical Colleagues in the development and design of the of Clinical Outcomes Assessment (COA) endpoint/measurement strategy
  • Management of study design of contracted research projects (budget negotiations, quality assurance of work conducted by vendors)
  • Providing technical expertise in the analysis and dissemination of COA data
  • Ensuring the scientific quality and integrity of all COA strategies to which you contribute either as a lead or as an advisor
  • Communication & collaboration effectively both  internally and externally to ensure that the COA strategy and deliverables are of value and align with overall program goals
  • Triage of 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
  • Contributions to, advising on briefing packages and participation at Regulatory interactions to ensure that COA strategies are acceptable and compliant with Regulatory guidance
  • Identification, evaluation, retention and overseeing of 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.)
  • Maintaining awareness of new methods, tools and data sources to ensure study methods represent current state of the science
  • Developing the PCOA 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

Education: 

PhD in Psychology, Epidemiology, Statistics, Public Health or related discipline with 10+ 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 5 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
  • 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
  • Ability to translate analytic skill into strategic vision of relevance to internal and external stakeholders
  • Demonstrated skills to develop/recommend strategies for the appropriate utilization of non-intervention studies (NISs) across clinical, medical, PHI and commercial disciplines to address key PCOA scientific and business questions
  • Experience managing and developing a team of technical staff and directing their priorities
  • Excellent interpersonal skills required: ability to understand and respond to multiple internal and external customers
  • Skilled in functioning within a matrix organization & managing through influence & cultural leadership
  • Demonstrated ability to lead teams and influence others effectively in rapidly changing environment
  • Strong Publication track record
  • Broad understanding of fundamental health services research methods (e.g., health economics, patient reported outcomes, study design, database analyses, epidemiology, statistics)

  • Able to independently engage all levels of stakeholders in PHI and the RU & BU through strategic thinking, leading change, and building collaborative partnerships in a matrix environment

  • Demonstrated ability to manage multiple projects (multitask) involving complex processes, significant budget, competing deadlines and rapidly shifting priorities
  • Demonstrated ability to lead teams and develop high performing individuals

Desired

  • Technical competency in psychometrics, or statistics 
  • Knowledge of the disease areas within Pfizer’s Therapeutic Areas
  • Technical competency in use of ePRO/eCOA and linguistic validation of COAs

1621900

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