Advanced Medical Solutions (AMS) Protocol Operations Lead (POL)

Role Summary
The Advanced Medical Solutions (AMS) Protocol Operations Lead (POL) is accountable for the end‑to‑end operational delivery of Advanced Medical Engagements (AMEs)—from study concept through reporting and close‑out—meeting agreed time, cost, quality targets through matrix leadership of the Study/Project Team(s).

This position reports to the Advanced Medical Solutions Team lead within US Medical Affairs. The POL collaborates with internal and external stakeholders including other members of the AMS team, study/project leads, contracted healthcare organization (CHCO) staff, business process operational leads and others as needed.

Primary Duties & Responsibilities
 

1) Study Leadership & Delivery

• Lead operational delivery at the study/project level, ensuring milestones are met across timeline, budget, and quality parameters.
• Establish and charter the Study Team, partnering with internal and external stakeholders to align goals and ways of working.
• Foster effective team dynamics, enable decision‑making, and document key decisions.
• Contribute to AMS and study/project-specific data management processes
• Keep project plan or study calendar updated. 

2) Planning, Governance & Change Control

• Develop, maintain, and execute study‑level operational plans (scope, schedule, budget, quality).
• Manage delivery of data/work products to plan; monitor and control forecast vs. actuals.
• Lead critical change control across schedule, scope, deliverables, and financial forecast.

3) Risk, Issue & Opportunity Management

• Drive proactive risk identification with the CHCO and Pfizer study team; create and maintain mitigation/contingency plans with cross‑functional buy‑in.
• Lead issue management and problem‑solving; ensure timely escalation and resolution.
• Provide concise Operational Reviews and presentations to senior leadership as requested.
• Keep abreast of changes in internal and external requirements and identify and analyze potential impact for AMEs 

4) Contracted Healthcare Organization Oversight

• Provide operational oversight of the CHCO, ensuring clarity of SOPs, training, deliverables, and performance expectations.
• Monitor CHCO performance, budgets, invoices, and contractual alignment; identify areas where corrective actions might be required and work with leadership to address

5) Quality, Compliance & Inspection Readiness

• Ensure studies are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.
• Lead inspection readiness preparation and coordination, including targeted QC activities and documentation completeness (e.g., TMF).
• Maintain continuous quality improvement of documentation to support compliance in an expedient manner 
• Maintain files of record for AMEs for compliance purposes
• Support routine and ad hoc internal audits of projects
• Ensure that the product/deliverable is the best it can be given time and budget constraints and work with leadership to address conflicts

6) Data Management & Evidence Generation Enablement

• Oversee delivery of Data Management activities, including CRF/eCRF development to relevant data standards.
• Partner with clinical, outcomes/HEOR, biostats, and data teams to ensure fit‑for‑purpose data acquisition, integrity, and flow.
• Drive clarity on site selection, recruitment projections, and patient identification and retention strategies in collaboration with the CHCO and study team if needed
• Develop and deploy templates across the AME process

7) Stakeholder Engagement & Communications

• Provide high‑quality study information to support decisions; maintain transparent communications on progress, risks/opportunities, and mitigations.
• Ensure appropriate issue escalation pathways and timely updates to stakeholders.
• Work with cross-functional stakeholders to understand implications of updates 
• Contribute to dissemination activities as appropriate
• Lead discussions with healthcare organizations to educate on Pfizer requirements, training, SOPs and how they apply to the project at hand  

8) Resource & Budget Management

• Optimize operational efficiency and team health across internal and CHCO resources.
• Manage study budget and spend vs. projections/contracts; support forecasts and accruals.

REQUIRED QUALIFICATIONS

• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with pee