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

Tempus; Chicago (IL); Híbrido; USD 192.000 - 264.000; Jornada completa

Descripción de la vacante

Tempus in Chicago seeks a Core Team Leader to own the development lifecycle for complex regulated diagnostics, leading a cross-functional Core Team across R&D, Regulatory, Quality, and Commercial to deliver products to market.

You will drive Stage-Gate governance, ensure Design Control compliance (21 CFR 820, ISO 13485), and align technical milestones with market value while managing executives and ensuring scalable operations.

Formación

• Advanced degree in Genetics, Molecular Biology, or Engineering.
• 10+ years in life sciences/diagnostics with 4+ years as Core Team Leader/Program Director in a matrixed environment.
• Deep experience in Oncology Diagnostics, NGS, or Liquid Biopsy.
• Experience with FDA Class II/III (PMA/510k) medical device development is preferred.
• Knowledge of Phased-Gate/Stage-Gate development cycles.

Responsabilidades

• Lead a cross-functional Core Team (Science, Engineering, Quality, Regulatory, Lab Ops) to deliver to the Target Product Profile on schedule.
• Drive Stage-Gate Reviews and synthesize complex data into clear business narratives for leadership.
• Ensure Design Control compliance (21 CFR 820) and ISO 13485 across development and launch.
• Coordinate R&D to Clinical Lab Ops transition, ensuring scalable order-to-result workflows for volume.
• Act as primary liaison between technical development and Commercial teams to translate milestones into market value.

Conocimientos

Stage-Gate development cycles

Cross-functional leadership

Executive presence

Influence without authority

Communication skills

Educación

PhD/MD/MS in Genetics, Molecular Biology, or Engineering

MBA (strong plus)

Descripción del empleo

Passionate about precision medicine and advancing the healthcare industry?Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.We are seeking an industry veteran to serve as the Core Team Leader (CTL) to support our growing product portfolio.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.This means real-time escalation and attribution of root causes when projects are trending off-track, inputs/expectations are not clear, and resources are not appropriately allocated to the work. CTLs are responsible for getting what they need from other teams to achieve the overall project objective and timeline, and speaking up loudly if that’s not happening.Key ResponsibilitiesCross-Functional Leadership & AccountabilityServe 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. You must 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). You will serve as the primary mediator, fostering constructive debate to reach rapid, data-driven decisions without needing constant escalation.Stage-Gate Governance & Strategic ExecutionLead the product team through formal Stage-Gate Reviews (Phase Exits). You must possess the executive presence to synthesize complex technical, clinical, and operational data into clear, actionable business narratives for the leadership team.Proactively identify critical path risks. You will drive difficult trade-off decisions between scope, timeline, and resources, escalating structural blockers to the Executive Leadership Team only when necessary.Collaborate with functional leadership to ensure appropriate resource allocation, ensuring the project aligns with the broader Tempus portfolio priorities.Design Control & Operational ScaleChampion a development process compliant with Design Control (21 CFR 820) and ISO 13485 standards. You will 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. You will ensure 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.QualificationsAdvanced 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.CompetenciesExpert knowledge of Phased-Gate/Stage-Gate development cycles. You understand the difference between tracking a timeline and leading a product to market.High emotional intelligence and communication skills required to manage up to executive level stakeholders. You act as the \"single source of truth,\" filtering noise and delivering clarity.Demonstrated ability to influence without authority. You can motivate and guide senior functional experts who do not report to you, maintaining momentum even when faced with organizational ambiguity.Ability to \"speak the language\" of both the R&D scientists developing the chemistry and the Commercial leaders selling the test.You don't just focus on the science; you focus on the manufacturability and operational scalability of the test.Key Success MetricsEfficiency 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, evidenced by reduced cross-departmental friction and unified project execution.Why Join UsAt 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.#LI-NK1#LI-HYBRIDPay Range: $192,000 - $264,000 USDThe expected salary range may vary for other locations. Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position.We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.About UsTempus was founded in August of 2015 by Eric Lefkofsky, after his wife was diagnosed with Breast Cancer. Shortly after he founded the company in an effort to bring the power of technology and artificial intelligence to cancer care, he convinced Ryan Fukushima to join as the company’s first employee. Ryan and Eric began assembling a world class team, focused on building the first version of a platform capable of ingesting real time healthcare data in an effort to personalize diagnostics.We built the platform for oncology and have expanded it to neuropsychiatry, cardiology, infectious disease (through COVID), and radiology. Despite our rapid growth, our mission remains the same—to help make sure patients are on the right drug at the right time, so they can live longer and healthier lives.Why Work Here?We’re looking for people who can change the world.Who question the status quo and don’t shy away from tough problems. For the builders who are never done building and the learners who are never done learning. We’re looking for passionate people with undying curiosity. Those who want to attack one of the most challenging problems mankind has ever faced. Head on.