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Sr. Manager Patient Centered Outcomes Assessment


Collegeville, PA 19426
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Job Details

The Patient-Centered Outcomes Assessment (PCOA) Senior Manager 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 Center of Excellence is positioned within Pfizer's Patient and Health Impact Function. The PCOA Sr. Manager will be responsible for the development, delivery and communication of 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 function with a One PHI mindset and will work in a closely aligned fashion with the BU Asset Leads and 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 Sr. Manager also leads within PHI by influencing internal stakeholders within Pfizer, and by assuming a leadership role in the continued development of the discipline.

**About Pfizer Patient and Health Impact**

Patient and Health Impact (PHI) is a group within Pfizer that brings together experts in health economics and outcomes research, real-world data, patient-centered outcomes assessment, market access, pricing, strategy and contracting. This group is responsible for ensuring patients have affordable, timely access to medicines and vaccines that can help optimize their overall health by generating evidence of value and working with payers and governments around the world to create access. Recognizing challenges with healthcare sustainability and the evolution to value-based care, this group is also exploring innovative approaches and new partnerships to transform the way Pfizer brings medicines and vaccines to market. We recognize our responsibility to be part of the solution and aim to be a leader in the industry.

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.


**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.**

**Specific responsibilities include:**

+ 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 and 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

+ Helps develop the PCOA CoE by modeling One Pfizer behaviors and championing the PCOA department vision and by influencing peers and PHI 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



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 5 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 7 in patient-reported outcomes or clinical outcome assessment).

**Skills and Competencies:**


**Self motivated and able to work independently**

**Strong process/project management skills**

+ 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

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

+ 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


+ 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

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

+ 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

**Travel in the US and/or internationally (approximately 10% to 25% depending upon need) will be required**

**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.

**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.

**Other Job Details:**

**Last Date to Apply for Job: Jan 17, 2018**

**Additional Location Information:** Collegeville, Global remote - at any Pfizer location or home office

**Eligible for Employee Referral Bonus** - YES

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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