Foresight Diagnostics Inc.

Technical Project Manager

• Lead execution of software-focused projects from initiation through delivery, including planning, timeline development, resource planning and coordination, risk management, and coordination of day-to-day activities
• Partner with a Product Owner/Manager to elicit, analyze, and document user and system requirements, partnering with laboratory operations, R&D, and other stakeholders to translate needs into clear, actionable specifications
• Hold cross-functional teams accountable to develop and maintain project and technical documentation, including requirements, user stories, workflows, and traceability artifacts in accordance with internal SOPs and regulatory standards
• Coordinate closely with software engineering, bioinformatics teams, and end user stakeholders to ensure requirements are understood, implemented correctly, and delivered on schedule
• Support development and deployment of LIMS and custom software tools, including enhancements, integrations, and new feature development
• Ensure compliance with applicable processes, including non-product software SOPs and, where applicable, product software development under IEC 62304 and design control frameworks, including documentation and traceability of requirements and deliverables
• Manage changes to software systems, including documenting updates, assessing impact, and supporting change control processes
• Track project progress and proactively identify risks, blockers, and dependencies, driving resolution to maintain timelines
• Facilitate cross-functional communication, ensuring alignment between technical and non-technical stakeholders
• Partner with software development and CLIA Laboratory stakeholders to plan and oversee testing and validation activities and management of user acceptance testing (UAT)
• Contribute to continuous improvement of software development and project management processes, tools, and documentation standards
• Adhere to formal governance processes to communicate project status, risks, and trade-offs; escalate issues as needed; and support the development of data-driven recommendations and business proposals to senior leadership to enable timely, informed decision-making
• Drive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution
• Cultivate, build and maintain positive and collaborative relationships with cross-functional teams

Program Manager

• Drive end-to-end execution of product development programs, including planning, scheduling, resource coordination, and risk management across assay, software, and systems development, ensuring alignment with regulatory and business requirements
• Support regulatory product development activities, ensuring alignment with regulated processes and quality systems, including design control processes (ISO 13485), software lifecycle standards (IEC 62304), change management, and quality system requirements (FDA, CAP/CLIA), including documentation and traceability of requirements and deliverables
• Coordinate regulatory submission readiness, including support for Investigational Device Exemptions (IDEs), pre-submissions, and other global regulatory filings
• Lead cross-functional alignment across R&D, software, regulatory, quality, and clinical teams to ensure clear requirements, priorities, and deliverables
• Translate product strategy into actionable program roadmaps, including timelines, milestones, and interdependencies, ensuring alignment with organizational priorities and securing stakeholder buy-in
• Extract and refine user needs and requirements from stakeholders and lead teams to focus on the most valuable deliverables
• Partner with Alliance Management to manage external biopharma and CDx partnerships, coordinating joint program plans, deliverables, timelines, and communication across organizations
• Adhere to formal governance processes to communicate program status, risks, and trade-offs; escalate issues as needed; and present data-driven recommendations and business proposals to senior leadership to enable timely, informed decision-making
• Identify, track and manage program risks and dependencies, proactively identifying mitigation strategies and driving issue resolution
• Drive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution
• Support continuous improvement of product development processes, tools, and cross-functional ways of working
• Cultivate, build and maintain positive and collaborative relationships with cross-functional teams.

• Lead, coach, and develop a team of Program and Project Managers, fostering a high-performance, accountable, and collaborative culture
• Own and oversee the program portfolio, ensuring alignment with company strategy, resource capacity, and organizational priorities
• Directly lead high-impact, cross-functional programs, including biopharma companion diagnostic (CDx) partnerships and other strategic initiatives
• Own and facilitate formal governance processes to communicate program status, risks, dependencies, and trade-offs; escalate issues as needed; and present data-driven recommendations and business proposals to senior leadership to enable timely, informed decision-making
• Enable executive decision-making by presenting clear, data-driven insights, recommendations, and business proposals to senior leadership
• Drive cross-functional alignment and accountability, influencing stakeholders across R&D, laboratory operations, regulatory, quality, clinical, software, and commercial teams
• Partner with Alliance Management to lead external partner engagement, including biopharma collaborations, ensuring alignment on joint plans, deliverables, timelines, and contractual commitments
• Ensure consistent, high-quality program execution across the portfolio, driving predictability in delivery of key milestones
• Identify, assess, and mitigate portfolio-level risks, proactively managing dependencies and escalating issues as needed
• Champion continuous improvement, scaling program management tools, processes, and best practices to support organizational growth
• Ensure alignment with regulated processes, including design controls, quality systems, and compliance requirements
• Develop and maintain program roadmaps, ensuring alignment with organizational priorities and securing stakeholder buy-in
• Extract and refine user needs and requirements from stakeholders and lead teams to focus on the most valuable deliverables.
• Lead risk and issue management, proactively identifying, mitigating, and resolving complex technical and operational challenges
• Ensure adherence to regulated processes, including design controls, change management, and quality system requirements (FDA, CAP/CLIA)
• Drive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution
• Partner with Alliance Management and external stakeholders to ensure seamless execution of joint programs and delivery commitments
• Champion continuous improvement throughout the organization, identifying and acting on opportunities to enhance operational efficiency
• Cultivate, build and maintain positive and collaborative relationships with cross-functional teams

Associate Director, Program Management

• Own end-to-end delivery of complex operational programs, including scope, schedule, budget, and resource strategy, ensuring alignment with regulatory and business requirements
• Lead cross-functional program execution across laboratory operations, clinical operations, R&D, and external partners to deliver on translational research, clinical, and commercial timelines
• Drive operational readiness initiatives, including laboratory site readiness for product and clinical trial launches, and process implementation across wet lab and dry lab workflows
• Adhere to and facilitate the formal governance processes to communicate program status, risks, dependencies, and trade-offs; escalate issues as needed; and present data-driven recommendations and business proposals to senior leadership to enable timely, informed decision-making
• Develop and maintain program roadmaps, ensuring alignment with organizational priorities and securing stakeholder buy-in
• Extract and refine user needs and requirements from stakeholders and lead teams to focus on the most valuable deliverables.
• Lead risk and issue management, proactively identifying, mitigating, and resolving complex technical and operational challenges
• Ensure adherence to regulated processes, including design controls, change management, and quality system requirements (FDA, CAP/CLIA)
• Drive cross-functional accountability, influencing without direct authority to ensure alignment, ownership, and timely execution
• Partner with Alliance Management and external stakeholders to ensure seamless execution of joint programs and delivery commitments
• Champion continuous improvement throughout the organization, identifying and acting on opportunities to enhance operational efficiency
• Cultivate, build and maintain positive and collaborative relationships with cross-functional teams

Senior Program Manager

Clinical Research

• You’ll own the day-to-day operational execution of assigned clinical studies and be accountable for quality, timelines, and partner relationships from protocol implementation through close-out.
• Implementing and maintaining primary accountability for clinical study protocols and operational plans aligned with corporate strategic objectives.
• Managing day-to-day study operations in compliance with GCP/ICH guidelines and applicable regulatory requirements.
• Coordinating study timelines across cross-functional teams to hit critical milestones, proactively identifying and resolving issues before they become blockers, and managing escalation when needed.
• Providing oversight and direction to study team members (CRAs, Project Coordination) on study deliverables and performance.
• Training partners, sites, and internal team members on study protocols, operational plans, and applicable guidelines and regulations.
• Co-developing and managing study materials through their full lifecycle- protocols, operational plans, and applicable guidelines and regulations.
• Overseeing the eTMF to ensure ongoing compliance and inspection readiness.
• Leading assigned internal and partner meetings, developing agendas, curating and filing minutes, and maintaining detailed dashboards and progress trackers that keep all stakeholders clearly informed.
• Supporting process improvement initiatives and serving as a subject matter expert and mentor within the clinical operations function.

Technical Project Manager

Program Manager

Associate Director, Program Management

Senior Program Manager

Clinical Trial Manager