Job description
At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.
Days Onsite: 3 days / week (Mon/Tues/Thurs)
Summary:
The Director of Informatics Project Portfolio leads the planning, prioritization, and delivery of a portfolio of informatics initiatives that enable clinical diagnostics, laboratory operations, and data-driven technology solutions. This role ensures that informatics programs - spanning clinical data systems, laboratory information management, analytics platforms, and software tools - are executed in alignment with business strategy, regulatory requirements, and patient-impacting quality standards.
The role operates at the intersection of informatics, software engineering, clinical operations, quality, and regulatory affairs, translating strategic objectives into reliably delivered, compliant informatics solutions.
Responsibilities:
- Own the informatics project portfolio across clinical, laboratory, and enterprise data systems
- Establish and lead portfolio governance, intake, and prioritization processes aligned with business, clinical, and regulatory priorities
- Partner with executive leadership to balance innovation, operational stability, compliance, and scalability
- Ensure portfolio alignment with quality systems, validation requirements, and regulatory expectations
- Oversee multiple complex, cross-functional informatics programs, including LIMS, clinical data platforms, analytics, and software applications
- Ensure projects follow appropriate SDLC, CSV (Computer System Validation), and design control processes
- Drive clear definition of scope, milestones, dependencies, risks, and success metrics
- Proactively manage risks related to data integrity, system validation, regulatory compliance, and clinical impact
- Serve as a key integrator across Informatics, IT, Software Engineering, Clinical Operations, Laboratory Operations, Quality, Regulatory, and Product teams
- Facilitate decision-making across stakeholders with competing priorities and regulatory constraints
- Communicate portfolio status, trade-offs, risks, and outcomes to senior and executive leadership
- Ensure informatics initiatives comply with applicable regulations and standards (e.g., CLIA, CAP, HIPAA, FDA 21 CFR Part 11, ISO 13485, GxP as applicable)
- Partner with Quality and Regulatory teams to ensure proper documentation, validation, and audit readiness
- Embed data governance, security, and privacy best practices into portfolio execution
Experience & Qualifications:
- Masters degree in Informatics, Computer Science, Life Sciences, or a related field
- 10+ years of experience in project, program, or portfolio management within healthcare, diagnostics, life sciences, or regulated environments
- Demonstrated experience leading informatics, clinical data, or laboratory systems initiatives
- Strong understanding of healthcare data systems and informatics workflows
- Proven experience working within regulated, quality-driven organizations
- Excellent executive communication and stakeholder management skills
- Advanced degree (MS, MBA, MPH, or PhD)
- Experience with diagnostics, genomics, or precision medicine platforms
- Experience with CSV, SDLC, delivery in regulated environments
- Technical fluency in healthcare informatics systems
- Risk-based decision making with patient impact in mind
- Familiarity with LIMS, Clinical systems, QMS, eQMS, or other lab and quality informatics platforms preferred.
- Ability to assess impact and define proportionate controls.
The hiring range for this position is$215,000 to $260,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.
Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.
Protecting Our Candidates: At Personalis, we value your security. Please note that all official correspondence from our team will come exclusively from @ personalis.com email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.
Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package and benefits including medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.)
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