Responsibilities
- 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
Requirements
- 5-7+ years of experience in program management, or equivalent combination of project and program management and relevant functional experience in biotechnology, diagnostics, clinical laboratory, or life sciences
- Strong familiarity with FDA, CAP/CLIA, and design control processes
- Proven ability to influence senior stakeholders and drive alignment in matrixed organizations
- Demonstrated success leading complex, cross-functional programs from concept through commercialization
- Strong analytical and operational mindset, with the ability to translate complex data into actionable insights
- Excellent executive communication skills, with the ability to tailor messaging across technical and non-technical audiences
- Experience building and scaling program management tools, frameworks, and governance models
- Proficiency with program management and collaboration tools (e.g., Smartsheet, Jira, Office Timeline, etc.)
- Ability to manage multiple concurrent programs in a fast-paced, high-growth environment
- Situational awareness, coupled with facilitation, problem solving, and conflict resolution skills to drive cross-functional decision-making
Nice to Have
- Experience supporting laboratory operations, clinical operations and trial execution
- Background in NGS diagnostics, including assay and software components
- PMP or equivalent certification
- MRD experience
Benefits
- Medical, dental, and vision
- Flexible PTO and paid holidays
- Parental leave
- 401(k) with company match
Work Arrangement
Hybrid
Team
Structure: high accountability, collaborative environment
Additional Information
- This position may be required to work across time zones as needed to support project schedules
