Senior Staff Program Manager, Clinical Sequencing

About This Role

The Senior Staff Program Manager, Clinical Sequencing will lead the development and commercialization of Next Generation Sequencing (NGS) instrument and assay solutions. This role focuses on advancing the Oncology technology roadmap within the Clinical Sequencing Division, creating RUO and regulated solutions.

Responsibilities

• Serve as Core Team Lead for multiple New Product Introductions and Sustaining programs.
• Proactively identify risks and mitigations: develop plans to address, facilitate tradeoff decisions at portfolio level, raise issues to stakeholders, remove obstacles, and seek resolution.
• Develop and control program timelines with internal functions and external partners.
• Build, monitor, and control budgets with Finance and vendors.
• Conduct internal and external team meetings: ensure data-driven decisions, supervise progress, identify and implement risk mitigations, and verify action items are completed.
• Present and communicate to senior leadership at Product Approval Committee (PAC) checkpoint meetings and additional PMO operating mechanisms.
• Ensure compliance with the company's Product Commercialization Process (PCP) and Quality Management Systems (QMS) for the development of RUO and regulated products.

Requirements

• BS in Molecular Biology, Genetics, Engineering, or related field
• 10+ years of program management experience
• Led multiple product development programs to completion
• Experience with regulated medical devices developed under 21 CFR Part 820 Subpart C - Design Controls (or other regulated product development)
• Proficiency with Project Management software
• Excellent collaboration skills
• Confident communication with various levels of management
• Proficiency in managing program budgets and contributing to Profit & Loss (P&L) statements
• Proventrack record of achieving results and driving decisions through persuasion and relationship-building
• Ability to foster positive connections across a matrix organization and navigate diverse perspectives to resolve conflicts

Qualifications

• BS in Molecular Biology, Genetics, Engineering, or related field
• 10+ years of program management experience, including principles, tools, and applications (i.e., timeline management, prioritization, cost estimation, risks analysis, and core team leadership). Led multiple product development programs, experience with complex or multi-system product development programs, and experience with regulated medical devices under 21 CFR Part 820 Subpart C - Design Controls.

Nice to Have

• Master's, MBA, and/or Certified Project Management Professional (PMP)

Skills

* Required skills

Benefits

Certifications