Predicine · 5 days ago
Project Manager, Companion Diagnostics (CDx)
Hayward, CA, US
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
8+ years expPredicine is seeking a highly skilled and collaborative Companion Diagnostics (CDx) Project Manager to lead complex CDx development programs. This role involves managing global project teams, overseeing program execution, and ensuring adherence to timelines and budgets while collaborating with various stakeholders.
BiotechnologyHealth DiagnosticsLife Science
Responsibilities
Lead and manage global, cross-functional project teams spanning scientific, clinical, operational, commercial, and regulatory disciplines
Act as the central point of contact for internal stakeholders, senior leadership, and external partners
Drive execution of CDx development programs, ensuring adherence to scope, timelines, quality standards, and budget
Oversee multiple complex initiatives simultaneously, including global co-development programs
Develop and maintain detailed project plans, schedules, Gantt charts, resource needs, and task lists
Identify, assess, and manage project risks using structured methodologies; implement mitigation strategies to avoid delays
Perform scenario analyses to support strategic decision-making for leadership and partners
Track program budgets, monitor variances, and communicate financial impacts proactively
Lead effective project meetings, prepare agendas, document key decisions, track risks, and monitor action items
Deliver clear and consistent communication to internal teams, external partners, and leadership
Provide frequent status updates, milestone tracking, and risk summaries
Influence cross-functional strategy and drive alignment across multiple organizational levels
Partner closely with Companion Diagnostics Development, R&D, Clinical Development, and other functions to support assay development, analytical validation, clinical validation, and regulatory activities
Coordinate project elements supporting FDA PMA submissions, global regulatory filings, and pharma co-development programs
Support technology transfer, manufacturing readiness, and commercialization planning for CDx products
Qualification
Required
8+ years of project/program management experience in diagnostics, medical devices, pharma, or biotechnology
Hands-on experience with CDx development, IVD development, or clinical biomarker programs
Familiarity with analytical & clinical validation workflows and global regulatory submissions (FDA, ex-US agencies)
Strong understanding of regulated environments, including 21 CFR 820, ISO 13485, and ISO 9001
Experience working within pharma co-development frameworks is a plus
Exceptional organizational, prioritization, and multitasking abilities across multiple complex programs
Strong stakeholder management, influence leadership, and conflict resolution skills
Excellent verbal and written communication for technical, cross-functional, and executive audiences
Proficiency with MS Project, Smartsheet, or similar Gantt-based project tools
Bachelor's or Master's degree (or equivalent experience) in a relevant field such as biological sciences, biotechnology, life sciences, or bioengineering
Preferred
Experience with NGS-based or liquid biopsy platforms strongly preferred
Direct PMA submission experience is highly preferred
PMP certification strongly preferred
Company
Predicine
Predicine is a molecular information company developing genomic profiling tests and robust algorithms for cancer diagnostics and monitoring.
51-200 employees
H1B Sponsorship
Predicine has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (4)
2023 (4)
2022 (4)
2021 (3)
2020 (2)
Funding
Current Stage
Growth StageLeadership Team
Shidong Jia
Founder & CEO
IL-Jin Kim
Chair, Oncology Biomarker Review Forum (OBRF)
Recent News
2025-05-05
Google Patent
2025-04-03
Company data provided by crunchbase