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

Role Summary
The Advanced Medical Solutions (AMS)Protocol Operations Lead (POL) is accountable for the endtoend operational delivery of Advanced Medical Engagements (AMEs)from study concept through reporting and closeoutmeeting 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 decisionmaking and document key decisions.
• Contribute to AMS and study/project-specific data management processes
• Keep projectplanor study calendar updated.

2) Planning Governance & Change Control

• Develop maintain and execute studylevel 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 crossfunctional buyin.
• Lead issue management and problemsolving; 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 fitforpurpose 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 highquality 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 peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
• Bachelors degree in life sciences drug development project management business or related field
• 6 years of relevant experience required with BA/BS or 5 years of relevant experience with MBA/MS
• Demonstrated success leading multiple clinical studies preferably noninterventional.
• Strong background in clinical operations with understanding of endtoend development processes and related regulatory requirements.
• Proven experience in CHCO/vendor oversight (highly desired).
• Track record of project management in matrix environments (time cost quality risk).
• Demonstrated budget management for large/complex programs with on/underbudget delivery history.
• Strong communication and collaboration
• Operational leadership of multiple clinical studies with CHCO oversight.
• Working knowledge of GCP SOPs and inspection readiness practices.
• Proficiency in risk/issue management change control and contingency planning.
• Understanding of CRF/eCRF development and TMF expectations.
• Strong command of budgeting/forecasting vendor performance management and contract awareness.
• Attention to detail collaboration and professionalism
• Flexibility and proactiveness
• Growth mindset

Preferred Qualifications

• Advanced degree and/or certification
• Extensive clinical operations and pharmaceutical business experience.
• Experience with alliance partnerships.
  

Other Job Details

• Last Date to Apply for Job: April 28 2026
• Eligible for Relocation Package: No
• Remote; some travel may be required.

#LI-PFE

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

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.