Director of Project Management

The Director of Project Management will play a critical leadership role in driving the successful launch of PathLight. This individual will lead cross-functional core teams to ensure alignment, execution, and timely delivery of key milestones associated with the LDT product launch. The role requires exceptional project leadership, strategic planning, and collaborative skills to guide teams across clinical, regulatory, quality, operations, and commercial functions.

Key Responsibilities:

• Core Team Leadership:
• Lead and facilitate cross-functional core teams to align on goals, timelines, and deliverables for the PathLight LDT product launch.
• Act as the central point of coordination and accountability for project execution.
• Project Planning and Execution:
• Develop and maintain comprehensive project plans, including timelines, resource allocation, risk assessment, and mitigation strategies.
• Track progress against key milestones and ensure proactive issue resolution.
• Stakeholder Engagement:
• Collaborate closely with internal stakeholders, including R&D, clinical, regulatory, quality, manufacturing, and commercial teams, to ensure seamless integration and execution of launch activities.
• Communicate project status, risks, and opportunities to executive leadership and key stakeholders.
• Regulatory and Compliance Leadership:
• Ensure project activities align with applicable regulatory and quality standards under 21 CFR Part 820 and other global requirements.
• Demonstrate expertise in launching products in regulated environments, including familiarity with IUO and IVD launches, labeling requirements, and post-market surveillance.
• Global Launch Expertise:
• Lead launch activities for the US market while planning for and supporting global expansion, including the EU, Japan, and Rest of World (ROW).
• Collaborate with regional teams to ensure compliance with local regulatory and market-specific requirements.
• Strategic Alignment:
• Ensure alignment with the overall corporate strategy, including regulatory compliance, quality standards, and commercial objectives.
• Support preparation for CLIA, CAP, and NYS DoH compliance, as required for PathLight’s launch.
• Process Improvement:
• Identify opportunities for operational improvements within the project management function and cross-functional workflows.
• Implement best practices for project management to enhance efficiency and collaboration.

Qualifications:

• Bachelor’s degree in a relevant field (e.g., life sciences, engineering, business); advanced degree preferred.
• 10+ years of experience in project management within the life sciences, diagnostics, or biopharmaceutical industry.
• Proven track record of leading cross-functional teams in the successful launch of diagnostic products or LDTs in a regulated environment.
• Strong understanding of clinical, regulatory, and quality requirements for LDTs, including familiarity with IUO and IVD launches and 21 CFR Part 820.
• Experience with global product launches, including in the EU, Japan, and ROW, as well as understanding of regional regulatory and market requirements.
• Familiarity with CLIA, CAP, and NYS DoH compliance, as well as FDA regulations for diagnostic products.
• Exceptional organizational, communication, and leadership skills.
• PMP or equivalent certification preferred.

• Company Benefits, Competitive salary and a dynamic startup culture with regular team events.

SAGA Diagnostics is an equal opportunity employer, fully committed to achieving a diverse and inclusive workplace that embraces and encourages applicants of every background.  The company’s policy regarding equal employment opportunity means that all decisions regarding recruitment, hiring, benefits, wage and salary administration, scheduling, disciplinary action and termination will be made without unlawful discrimination on the basis of sex, gender, race, color, age, national origin, religion, disability, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, citizenship status, pregnancy or maternity, veteran status, or any other status protected by applicable federal, state or local law. If you require reasonable accommodation in completing an application, interviewing, or otherwise participating in the employee selection process, please direct your inquiries to hr@sagadiagnostics.com. SAGA Diagnostics is a participant in the E-Verify program, learn more about the program and review our required disclosures here and here.