Job Description

WHY PATIENTS NEED YOU

CSTL is accountable for planning and executing clinical studies, ensuring timely delivery within budget and quality standards, and leading multiple complex global studies or programs. The role involves collaboration with functional leadership for resource optimization and proactive risk management.

WHAT YOU WILL ACHIEVE

• A clinical operations and development specialist with extensive experience in planning and executing clinical studies, consistently applying this expertise to the design and conduct of trials in accordance with program and portfolio strategies for specific categories or therapeutic areas.

• Act as a strategic partner providing insights from a clinical operations perspective with functional lines and key stakeholders

• Serves as the primary contact responsible for providing input into study design, ensuring practical feasibility, streamlined planning, and timely delivery of clinical studies within approved budgets and quality standards.

• A skilled project manager and matrix leader, accountable for guiding multidisciplinary study teams in the successful execution of multiple complex global studies and programs.

HOW YOU WILL ACHIEVE IT

• Lead the study team and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs

• Lead and coordinate the execution of clinical studies from sourcing strategy and study specification development for requests for proposals, study start-up through database release and inspection readiness to ensure timely delivery of quality study data.

• Provide input to and supports compilation of sections of the clinical study reports (CRSs).

• Accountable to ensure effective study team meeting scheduling, records, and communications.

• Accountable for strategic planning and decision making at the study level in line with program objectives.

• Accountable for issue resolution and act as point of awareness for clinical trial execution issues.

• Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross- functional study team performance and accountable for effective study team operations.

• Lead study team chartering and team health check process.

• Partner and collaborate with functional line leadership to ensure optimal study team resourcing.

• May represent the study team at appropriate asset team and sub-team discussions.

• Escalate issues to Clinical Operations Leadership when study team has been unable to resolve or adequately manage/mitigate.

Quality and Risk Oversight

• Drive monitoring and remediation of quality metrics.

• Drive functional lines to ensure inspection readiness.

• Maintain active awareness and appropriate escalation of all Significant Quality Events (SQEs) reported for study and ensures appropriate prioritization and management of events through to resolution.

• Lead the study team in the management and communication of risk management plans including risk assessment and mitigation strategies.

• Proactively identify operational issues and lead the team in identifying options to de-risk and capitalize on opportunities.

• Maintain continuous study risk planning and guide the team in proactive issue resolution and risk management.

Vendor Oversight

• Quality oversight of the Clinical Research Organization (CRO) if required by the Pfizer operating model and of the CRO deliverables related to study execution.

• Partner with relevant team functions to ensure vendor delivery meets quality and operational plan expectations

Study Metrics & Reporting

• Act as a single, authoritative source of study information and lead study level status reporting per organizational norms and expectations.

• Ensure systems are maintained with up-to-date study status, risks, and issues.

• Oversee operational metrics across study and partner with functional lines to manage trends.

Governance & Decision Points

• Drive proactive planning to navigate the team through governance and decision point milestones to support study deliverables to maintain development timelines.

• Lead preparation for and present the study to relevant governance per organizational norms and expectations.

Non-project Initiatives

• Support Clinical Operations continuous improvements initiatives to maintain high standards of operation and quality within the organization.

QUALIFICATIONS

Must-Have

• Applicant must have a bachelor's degree with at least 8+years ofexperience.

• Extensive clinical studies conduct, global clinical study operations, and a thorough understanding of the processes associated with project and study management, knowledge of Good Clinical Practices (GCPs), ICH guidelines, monitoring, clinical, and global regulatory operations.

• Bachelor’s degree in one of the disciplines related to drug development or business required.

• Broad experience in a clinical study execution discipline (e.g., senior study management expertise, lead data management expertise, clinical leadership expertise).

• Demonstrated project management and cross-functional leadership experience.

• Experience in understanding key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget.

• Strategic thinking and targeted problem-solving skills.

• Ability to lead cross-functional teams, identify, resolve & escalate issues.

• Project management expertise.

• Ability to leverage negotiation and conflict resolution skills to enhance team performance and delivery.

• Strong communication and interpersonal skills and ability to represent & communicate clearly to senior leaders and governance bodies.

• Ability to develop successful collaborations with internal and external partners

• Ability to understand and assimilate high-level data from all functions.

• Skilled: ability to use Artificial Intelligence tools for various tasks.

Nice-to-Have

• M aster's degree with at least 7+years ofexperience; ORa PhD with 5+ years of experience, MDwith4+ years of experience

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.

OTHER JOB DETAILS

• Last Date to Apply for Job: June 24, 2026

• Additional Location Information: USA - Any Pfizer Site

• Eligible for Relocation Package – NO

• Secondment 12 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

• Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).

• Note: This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondee’s home market.

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

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.

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

Medical