Director of Project Management
Director of Project Management
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Salary Not Disclosed
1 Vacancy
Job Description
The Director of Project Management will play a critical leadership role in driving the successful launch of PathLight. This individual will lead crossfunctional core teams to ensure alignment 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 crossfunctional 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 .
- Project Planning and :
- 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 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 postmarket surveillance.
- Global Launch Expertise:
- Lead launch activities for the US market while planning for and supporting global expansion.
- Collaborate with regional teams to ensure compliance with local regulatory and marketspecific 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 PathLights launch.
- Process Improvement:
- Identify opportunities for operational improvements within the project management function and crossfunctional workflows.
- Implement best practices for project management to enhance efficiency and collaboration.
Requirements
Qualifications:
- Bachelors 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 crossfunctional 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 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.
Benefits
- 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 companys 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 SAGA Diagnostics is a participant in the EVerify program learn more about the program and review our required disclosureshereandhere.
Required Experience:
Director
Employment Type
Contract
