Senior Strategic Program Manager - Regulated Biotech NPI

Remote Genie

California

Hybrid

USD 141,000 - 176,000

Full time

31 hours ago
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Job summary

Natera in the United States is seeking a Senior Strategic Program Manager to lead cross-functional programs within the Program Management Office, focusing on R&D and design control in a regulated environment.

You will manage all phases from concept through commercialization, develop key documents, track progress with data-driven updates to leadership, and collaborate with R&D, operations, engineering, and business teams.

Qualifications

  • Bachelor’s degree in Biology, Molecular Biology, Biochemistry, Bioinformatics, Computer Science, or a related technical discipline (or equivalent experience) required; PhD degree preferred.
  • Minimum 4 years of program management experience in biotech, life sciences, or another regulated technical industry.
  • Project management certification or training (e.g., PMP or equivalent) required.
  • Background in research, assay development, systems engineering, lab operations, or software development is highly desirable.
  • Familiarity with laboratory informatics systems and processes such as LIMS, sample accessioning, sequencing pipelines, and results reporting preferred.
  • Minimum 5 years of project budget management experience preferred.
  • Experience with software development lifecycle principles, data architecture patterns (e.g., SOA), and agile tools (e.g., Jira, GitLab) a plus.

Responsibilities

  • Drive cross-functional programs that bring new clinical products to market and enhance existing ones, with a focus on Design Control and New Product Introduction in a regulated environment.
  • Partner across teams—including R&D, business, operations, and engineering—to define goals, milestones, and plans that balance resources, risks, and priorities.
  • Lead all phases of product development, from early concept through commercialization and post-launch, ensuring alignment, transparency, and momentum.
  • Develop and maintain key program documentation, such as project plans, protocols, and reports, to keep teams informed and accountable.
  • Track progress and communicate results through clear, data-driven reports and regular updates to senior leadership.
  • Champion Design Control excellence, managing gate reviews, design freezes, technical assessments, change control, and regulatory deliverables.
  • Facilitate productive team meetings that drive decisions, surface and mitigate risks, and maintain focus on program objectives.
  • Guide trade-off and risk decisions to balance technical, business, and regulatory considerations and challenge assumptions while adapting to evolving priorities.
  • Foster collaboration and problem-solving, helping teams overcome challenges, resolve conflicts, and deliver high-quality results on time.
  • Coordinate joint development efforts with external partners to ensure seamless integration and progress.
  • Manage up to 4 dynamic programs simultaneously, anticipating challenges and maintaining progress in a fast-paced environment.

Skills

Gantt charts
Risk/RAID logs
Cross-functional collaboration
Communication skills
Independence
Growth mindset
Time management
Multitasking

Education

Bachelor's degree in Biology, Molecular Biology, Biochemistry, Bioinformatics, Computer Science, or related
PhD degree preferred

Tools

SmartSheet
Jira
GitLab

Job description

Natera in the United States is seeking a Senior Strategic Program Manager to lead cross-functional programs within the Program Management Office, focusing on R&D and design control in a regulated environment.

You will manage all phases from concept through commercialization, develop key documents, track progress with data-driven updates to leadership, and collaborate with R&D, operations, engineering, and business teams.

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