The Close-Out & Maintenance (COMET) Regional Lead is accountable for the strategic direction, performance, and delivery of clinical trial maintenance and close-out activities across one or more regions within the GSSO organisation. This role leads a multi-layered regional organisation responsible for the timely, compliant, and cost-effective execution of study maintenance and close-out activities, ensuring alignment with regulatory requirements, ICH GCP, and Pfizer standards.

Operating as part of a globally connected leadership team, the Regional Lead works in close partnership with peer Regional Leads to ensure consistent, standardized, and high-quality COMET delivery across all regions, while enabling appropriate regional flexibility. The role plays a critical part in shaping and executing the COMET operating model, driving operational excellence, and ensuring seamless collaboration across Country Operations, Study Management, Site Operations, and enabling functions.

Job Responsibilities

Regional Leadership & Global Alignment

• Lead the strategy and execution of COMET delivery across one or more regions, ensuring alignment with global priorities and performance expectations
• Partner closely with peer Regional Leads to ensure consistency in delivery, processes, and performance standards across regions
• Contribute to the ongoing evolution of the COMET operating model, ensuring scalable and standardized approaches are adopted globally
• Act as a regional subject matter expert, providing insight into regional needs, risks, and opportunities to shape global direction
• Support the development and alignment of global priorities through active participation in COMET leadership forums

Operational Delivery & Performance Management

• Ensure high-quality, timely, and compliant delivery of:
  • Ongoing study maintenance activities (e.g. document updates, regulatory tracking, contract/budget amendments)
  • Study close-out activities
  • TMF finalisation and archival readiness
• Establish and monitor KPIs across assigned regions, including cycle times, quality metrics, and productivity measures
• Drive consistency of delivery through standardized processes, tools, and performance frameworks
• Identify and address risks to delivery, working collaboratively across regions to implement solutions and share best practices
• Ensure strong inspection readiness and support audit activities across the region

Resource & Vendor Management

• Lead a regional organisation (typically multiple teams) including managers, individual contributors, and contingent/vendor resources
• Oversee resource allocation, capacity planning, and demand forecasting for assigned regions
• Partner with peer Regional Leads to optimize resource utilisation across regions, balancing workload and capability
• Support the implementation and oversight of vendor/FSP models, ensuring effective and compliant external partnerships
• Contribute to financial planning and cost optimization initiatives within the regional scope

Process Excellence & Compliance

• Drive standardisation and harmonisation of maintenance and close-out processes across regions in partnership with other Regional Leads
• Ensure full compliance with ICH GCP, regulatory requirements, and Pfizer SOPs and policies
• Partner with Process & Standards teams to implement improvements, training, and governance frameworks
• Promote a culture of continuous improvement, identifying opportunities to enhance efficiency, quality, and scalability
• Ensure consistent application of systems, tools, and documentation standards to maintain data integrity and audit readiness

Stakeholder Engagement & Collaboration

• Build strong partnerships with:
  • Study Management & Clinical Study Teams
  • Site Operations and Country Operations
  • Regulatory, Quality, and enabling functions
• Act as a key point of contact for regional stakeholders while ensuring alignment with global COMET leadership
• Collaborate with other Regional Leads to provide a unified interface to global stakeholders
• Proactively manage expectations, risks, and escalations impacting delivery

People Leadership

• Lead, develop, and coach a high-performing regional organisation
• Drive talent development, succession planning, and capability building across teams
• Foster a collaborative, inclusive, and performance-driven culture aligned to Pfizer values
• Promote knowledge sharing and connectivity across regions to build a globally integrated COMET organisation
• Ensure consistent performance management andengagement across teams

Basic Qualifications

• Bachelor’s degree
• Extensive experience in clinical trial operations
• Demonstrated experience leading regional or global teams in a matrix environment

Preferred Qualifications

• Advanced degree (MBA, MSc, or equivalent)
• Strong clinical trial operations experience
• Strong understanding of end-to-end clinical trial lifecycle
• Experience in performance management, KPI frameworks, and operational delivery
• Experience working with vendor/FSP delivery models

Key Skills & Capabilities

• Ability to balance regional accountability with global alignment
• Strong leadership of multi-layered, matrixed teams
• Strategic thinking with focus on execution and delivery excellence
• Strong stakeholder engagement and influencing skills across regions
• Proven ability to drive performance, consistency, and standardisation
• Experience in process improvement and operating model evolution
• Strong resource management and capacity planning capability
• Collaborative leadership style with ability to work in a peer-led global model
• Excellent communication and decision-making skills

 

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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

May be required to travel.

 
Work Location Assignment: Remote

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.