layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Associate Director / Director, Clinical Project Delivery at Immunome

Clinical Project Delivery
Own cross-functional facilitation of clinical study teams through the trial lifecycle.
Own study-level timeline development, tracking, and reporting for assigned trials.
Develop and maintain enrollment graphs and dashboards, ensuring accuracy and timely updates to inform decision-making.
Monitor project delivery metrics (timelines, milestones, enrollment, budget adherence, TMF and vendor KPIs) and drive corrective action when studies are at risk.
Lead cross-functional planning, execution, and delivery of assigned clinical trials on time, within budget, and to quality standards.
Identify operational risks and implement mitigation strategies to ensure successful trial delivery.
Clinical Operations Leadership
Support resource planning and capability building to meet the demands of a rapidly expanding clinical portfolio.
Champion a culture of accountability, collaboration, and continuous improvement.
May be assigned one or more direct reports with the expectation of providing coaching, mentorship, and development.
Guide and mentor new and junior Clinical Operations team members.
Vendor Management
Own CROs and central lab vendor relationships and oversight for assigned studies.
Owns vendor identification, selection, contracting, and onboarding activities in partnership with Finance, Legal, and clinical study teams.
Manage and monitor vendor performance against contractual obligations, operational timelines, and quality and performance metrics.
Lead governance meetings, oversight activities, and drive issue escalation and resolution to ensure timely and effective trial execution.
Quality Assurance and Regulatory Compliance
Ensure adherence to ICH-GCP, FDA, EMA, and global regulatory requirements for assigned trials.
Partner with Quality Assurance and the Clinical Study Team to ensure ongoing inspection-readiness and implement corrective actions as needed.
Drive operational excellence to ensure data integrity and consistent trial conduct across assigned trials.
Cross-Functional Collaboration
Align cross- functionally on program objectives and study execution plans.
Partner with Clinical Site & Trial Operations, Clinical Field Monitoring & Trial Operations, and Clinical Development Systems to align on trial delivery strategy and execution.
Partner with cross-functional teams to identify and mitigate study delivery risks.
Provide study-level operational input into program-level discussions and decisions.
Support regulatory submissions (INDs, NDAs, BLAs) and health authority interactions as needed for assigned studies.
Budget and Resource Management
Partner with Finance to manage and forecast study-level budgets, including change orders ensuring alignment with corporate priorities and program timelines.
Maintain financial oversight for vendor and study-related activities, strictly tracking, managing, and escalating Change Orders and Change Notifications.
Track and report on budget adherence for assigned studies.

Associate Director / Director, Clinical Project Delivery

Employer job description

Responsibilities

Qualifications

Equal opportunity and accommodations

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