Senior Director, Research Strategy and Operations (Core Team Leader)

In this high-impact role, you will act as the "Leader of the Product Development Lifecycle." You will move beyond simple project coordination to assume full accountability for the execution and commercial launch of complex regulated diagnostic products. You will lead a cross-functional Core Team - comprising leaders from R&D, Clinical, Regulatory, Quality, Software, and Operations - to navigate the journey from concept to commercialization. This is a matrix leadership role. You will partner with a Product Manager (who defines market strategy) and a Project Manager (who manages tactical schedules), while you provide the strategic glue, operational oversight, and decision-making authority required to deliver the product to market.

Key Responsibilities

Cross-Functional Leadership & Accountability

• Serve as the single point of accountability for the development lifecycle, ensuring the team delivers against the Target Product Profile (TPP) and Product Requirements against a defined timeline.
• Lead a dedicated Core Team of functional heads (Science, Engineering, Quality, Regulatory, Lab Ops) without direct line authority.
• Effectively negotiate priorities, drive consensus among peers with competing incentives, and align disparate groups toward a shared vision.
• Ensure the technical and clinical vision defined at the start of the project is consistently understood and executed across all technical sub-teams, preventing scope creep or strategic drift.
• Proactively identify and resolve friction between functional groups (e.g., Commercial timelines vs. R&D feasibility).
• Serve as the primary mediator, fostering constructive debate to reach rapid, data-driven decisions without needing constant escalation.

Stage-Gate Governance & Strategic Execution

• Lead the product team through formal Stage-Gate Reviews (Phase Exits).
• Synthesize complex technical, clinical, and operational data into clear, actionable business narratives for the leadership team.
• Proactively identify critical path risks and drive difficult trade-off decisions between scope, timeline, and resources.
• Collaborate with functional leadership to ensure appropriate resource allocation, ensuring the project aligns with the broader Tempus portfolio priorities.

Design Control & Operational Scale

• Champion a development process compliant with Design Control (21 CFR 820) and ISO 13485 standards.
• Guide the team through the rigors of LDT, 510(k), or PMA regulatory pathways.
• Oversee the critical transition from R&D to Clinical Lab Operations, ensuring the "order-to-result" workflow is robust, scalable, and ready for commercial volume prior to launch.
• Act as the primary link between technical development and the Commercial organization, ensuring that technical milestones translate into market-ready value propositions.

Qualifications

• Advanced degree (PhD, MD, MS) in Genetics, Molecular Biology, or Engineering required.
• MBA is a strong plus.
• 10+ years in the life sciences/diagnostics industry, with at least 4+ years serving as a Core Team Leader, Product Development Lead, or Program Director in a matrixed environment.
• Deep experience in Oncology Diagnostics, NGS, or Liquid Biopsy is essential.
• Experience navigating FDA Class II/III medical device development (PMA/510k) is highly preferred.

Competencies

• Expert knowledge of Phased-Gate/Stage-Gate development cycles.
• High emotional intelligence and communication skills required to manage up to executive level stakeholders.
• Demonstrated ability to influence without authority.
• Ability to "speak the language" of both the R&D scientists developing the chemistry and the Commercial leaders selling the test.
• Focus on the manufacturability and operational scalability of the test.

Key Success Metrics

• Efficiency and success rate of Stage-Gate (Phase Exit) presentations to the Executive Committee.
• Adherence to the roadmap timeline while ensuring Design Control compliance.
• Seamless transfer to Operations with met KPIs for Turnaround Time (TAT) and success rates upon launch.
• High engagement and clarity scores from cross-functional Core Team members.

At Tempus AI, we believe the future of medicine lies at the intersection of science and data. In this role, you will be at the center of that evolution, transforming how liquid biopsy and xF diagnostics provide clarity to clinicians and better outcomes for patients.