The Real World Evidence (RWE) Platform:

The Chief Medical Affairs Office’s RWE Platform is responsible for establishing global scientific leadership and stature through the generation of integrated, end-to-end observational real-world evidence serving all therapeutic areas from proof of concept (POC) trials through Loss of Exclusivity (LOE) for priority pipeline candidates, pipeline supplementation through business development, and marketed inline products. The Platform fully centralizes RWE, epidemiology, outcomes research, RW-relevant health informatics, and biostatistics talent from global, international developed market (IDM) and emerging markets (EM) into one team to drive quality and efficiency through internalized work.

ROLE SUMMARY

The RWE Platform Quality & Compliance capability pilar is responsible to ensure all RWE activities related to observational research studies, hybrid interventional  and/or RWE trials comply with all applicable quality regulations, codes and standards, and upholds a quality and Integrity focused culture in which each person is required to carry out their responsibilities with proper regard for quality and to ensure the highest priority is placed on the safety and efficacy of our products, the safety of our patients, the integrity of data, and the trustworthiness of interactions with our Stakeholders.

The VP RWE Platform Quality Compliance role leads a team of Sr Director through Manager-level quality specialists in therapy dedicated teams and subject specialized areas. The VP’s leadership team will serve as single points of contact for all RWE Quality & Compliance needs as articulated in the RWE Quality & Compliance division documentation (quality plans/manuals, SOPs, protocols, etc.) describing how they execute the QMS for regulated activities within their area, meeting the minimum requirements defined for the RWE QMS.

The VP will be responsible for collaborating with Pfizer’s Senior Leadership cross functionally to understand and translate health authorities’ perspectives on the regulatory use of RWE and the release of new RWE guidance and develop actionable business processes to ensure high quality and timely delivery of compliant RWE projects.  The head develops KPIs and success metrics with each of their Platform Leadership colleagues. They then direct their teams to work in highly-matrixed cross-functional teams to review the design and study concepts of draft protocols for RWE and compliance with Pfizer standards. 

This leader will also work across other Platform capabilities’ senior leaders and in collaborations with Platform peers including VP’s and Heads of Evidence Strategic Planning & Business Operations, RWE Clinical Affairs & Clinical Operations, and RWE Platforms & Partnerships.

Outside of the Platform, the VP will work with leaders from Biostatistics & Data Management, Global Regulatory Affairs, Clinical Pharmacology / Pharmacometrics, HEOR, Legal/Compliance, and others to achieve research and business objectives. They will also serve as an external face for Quality & Compliance for RWE study execution to Pfizer, providing expert knowledge to its leaders. They will serve as a trusted expert with study / analytical KOLs, key regulatory agencies (e.g., FDA in the US, EMA in Europe, MHRA in the UK, PDMA in Japan, CDE in China), HTAs/Payers, and other stakeholders.

This role will be responsible for integrating into the Pfizer QMS with cross-functional partners, determining the best approaches and process designs, selecting appropriate real world data quality standards, and ultimately for enabling the teams to deliver quality all in-scope evidence. They will monitor their teams’ performance and report metrics, challenges, and opportunities back to the CMAO Evidence Generation.

ROLE RESPONSIBILITIES

• Strategic collaboration with RQA and CQA to develop and implement a strategic audit program for RWE EvGen Platform activities. 
• Leads the creation of solutions to highly complex, multi-faceted, and unique problems. Has a problem-solving and life long learning mind set.
• Influences organization-wide decisions and is accountable for decisions related to RWE Platform Quality.
• Direct oversight of the RWE EvGen Platform internal audit program
• Serves as strategic advisor on key organization-wide initiatives (One QMS, NIS updates) that may impact Enterprise or Division operational or functional excellence.
• Reports on findings, inefficiencies and gaps, site weaknesses, ineffective procedures, policy exceptions and discrepancies and, as needed, recommends appropriate corrective actions.
• Perform trending analysis of audit observations or compliance issues and addresses trending issues with appropriate personnel for resolution and reports metrics in management review.
• Evaluate responses to audit findings for adequacy and timeliness and approve closure of commitments for both internal and external audits as needed. 
• Ensures the development and delivery of auditor training programs are suitable and effective.
• Provides audit expertise and guidance across the site to assure compliance.
• Accountable for maintaining the Internal Audit program’s processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established Pfizer standards and guidelines.
• Actively participates in continuous improvement programs for internal audits to align with business strategies across the Pfizer network.
• Influences senior leadership of Pfizer and the external environment.
• Timely escalation of any quality, human resource, environmental, safety or product issues.
• Partners with Pfizer SOP QMS08 Audit Process BPO for scope and process assessment for RWE EvGen activities, as appropriate.
• Is accountable for creating an environment where Quality, Continuous Improvement, Learning and Innovation are embedded in day-to-day operations across RWE Platform and Medical Affairs.
• Develops and defines the overall people, technological and financial resourcing strategy for Enterprise or Division; Is a leader of leaders.

BASIC QUALIFICATIONS

Candidate will demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

• BS + 20+ Years relevant experience Global Regulatory affairs, Pharma QMS Development and Management, Clinical Quality, GCP Auditing, Regulatory Inspections experience; MS, MSJ, MBA +18 years relevant experience; PharmD/PHD + 15+ years relevant experience; MD + 9+ years relevant experience

Experience required in:

• GXP Quality Management System development and oversight;
• Business process development and document management, including Policies, SOP’s and all other supporting document types;
• Medical Affairs, and epidemiological study development and data quality standards.
• Demonstrated expertise in at least two categories.
• Familiarity with pharmaceutical product development; and non-interventional/observational research studies.
• Experience having led and grown (staff and budget) at least one organizational structure with substantial supervisory (at least 10 people with responsibility for hiring) & fiscal / budgetary responsibility.
• A high degree of energy, enthusiasm and motivation for scientific discoveries and developing a team.
• Significant cross-functional leadership/management experience including colleagues from different countries and cultures.
• Leadership in a related field, e.g., in professional societies, government, international bodies, etc.
• Demonstrated ability to create and articulate global strategies, supervise & develop highly-skilled and seasoned professionals, and to lead across diverse cultures and geographies through influence even in the absence of authority
• Able to act independently as well as cross-functionally to achieve program goals.
• Excellence in speaking/communicating publicly as evidenced by presentations at congresses, participation on committees/working groups, etc.
• Demonstrated strong work ethic, and proven track record of delivering high quality within timelines.
• Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets.
• Ability to discuss scientific aspects of drug development, also comfortable in discussing commercial and regulatory issues.
• Able to lead teams through ambiguity and have them excited to follow a quality focused vision.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Domestic and/or international travel up to 20% possible

Other Job Details:

Last Date to Apply for Job: April 19th, 2024

Additional Location Information: US - Any Pfizer site

Eligible for Relocation Package: No

#LI-PFE

The annual base salary for this position ranges from $239,300.00 to $398,900.00.* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 30.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

* The annual base salary for this position in Tampa, FL ranges from $215,400.00 to $359,000.00.

Relocation assistance may be available based on business needs and/or eligibility.

Quality Assurance and Control