Director, CDx & Clinical Trial Portfolio Management

Position Overview

We are seeking an experienced Director, CDx & Clinical Trial Portfolio Management to lead portfolio management across the growing pharma CDx partnership portfolio and establish a scalable PMO portfolio-management capability for clinical-trial opportunities, including early intake and triage of incoming opportunities to identify non-standard requirements, feasibility, resource and capacity needs, dependencies, cost and required PM support.

This individual will work at the intersection of IVD/CDx Program and Portfolio leadership, Product, Business Development, Alliance Management, Finance, Clinical Trial Services, Development Program Management, and cross-functional development teams.

The role will provide the portfolio-management expertise needed to evaluate new opportunities, assess feasibility and true cost-to-deliver, understand resource and capacity requirements, identify cross-program dependencies and tradeoffs, and translate strategic priorities and external commitments into executable programs.

The Director will establish scalable portfolio-management frameworks, governance, and forward-looking resource and capacity planning across the portfolio and will build and lead the program-management capability needed to support continued growth.

Key Responsibilities

• CDx Portfolio Management: Lead portfolio management across active and pipeline pharma CDx partnerships, maintaining an integrated view of commitments, milestones, dependencies, risks, resource needs and upcoming decisions across the portfolio.
• Opportunity Assessment & Pre-Deal Feasibility: Partner with Business Development, Product, Alliance Management, Clinical and functional teams to evaluate new CDx opportunities before commitments are made. Assess scope, deliverables, development and regulatory requirements, timelines, true cost-to-deliver, resource and capacity needs, dependencies, assumptions and portfolio impact.
• Portfolio Strategy & Planning: Develop and maintain a forward-looking view of CDx and clinical-trial demand, capacity and resource needs. Identify cross-program conflicts and tradeoffs and develop recommendations on prioritization, sequencing, resource allocation and timing to support portfolio-level decision making.
• Clinical Trial Intake & Triage: Lead the PMO portfolio review of incoming clinical-trial opportunities, partnering with Clinical, Product, BD and relevant functional teams to identify standard versus non-standard requirements early and assess feasibility, complexity, resource and capacity needs, cost, dependencies, operational readiness and required PM support before commitments are made.
• Clinical Trial Portfolio Management: Establish a scalable portfolio-management and governance model for non-standard clinical-trial requirements. Ensure appropriate functional ownership, integrated planning, visibility to dependencies and risks, and PM support based on complexity, portfolio priority and available capacity.
• CDx Partner Governance: Provide portfolio-level oversight across pharma partnerships and establish consistent governance practices for partner programs. Partner closely with Alliance Management and program teams to ensure external commitments, key decisions, risks and escalations are visible and appropriately managed.
• Cross-Functional Program Integration: Partner closely with CDx Development PMs and cross-functional leaders across Product, R&D, Clinical, Regulatory, Quality, Operations, Software/Bioinformatics and other functions to ensure external commitments are connected to executable internal plans and that critical dependencies and gaps are identified early.
• Portfolio Governance & Executive Visibility: Establish and maintain portfolio-level reporting, risk and decision management, escalation mechanisms and regular portfolio reviews that provide leadership with clear visibility into portfolio health, upcoming decisions, capacity constraints and areas requiring tradeoffs or intervention.
• PM Capability & Process Development: Build scalable portfolio-management processes, tools and operating models across CDx partnerships and clinical-trial work, including opportunity assessment, portfolio planning, governance, resource forecasting, risk management and decision-making frameworks.
• People Leadership: Build and lead the CDx and clinical-trial portfolio-management capability, including management and development of PM talent. Provide leadership and oversight to PM resources supporting day-to-day CDx partnership management and selected non-standard clinical-trial work.

Qualifications

• Significant leadership experience in CDx/IVD program management, portfolio management, partnership management, or development management, with demonstrated experience across multiple complex programs or pharmaceutical partnerships.
• Deep understanding of the CDx/IVD development lifecycle, including development, analytical and clinical validation, regulatory strategy and submission, design transfer, and commercialization considerations.
• Demonstrated experience evaluating and operationalizing new CDx opportunities, including scope, feasibility, timelines, costing/budgeting, resource planning, and capacity assessment.
• Experience managing across a portfolio of programs or partnerships and identifying cross-program dependencies, resource conflicts, portfolio risks, and tradeoffs.
• Significant experience working directly with pharmaceutical partners and senior/executive internal and external stakeholders.
• Demonstrated ability to work across Business Development, Product, Clinical, Regulatory, R&D, Finance, Operations, Software/Bioinformatics, and other cross-functional organizations.
• Experience establishing scalable program- and portfolio-management frameworks, governance, and operating processes.
• Strong executive communication and ability to synthesize complex program, resource, financial, and technical information into clear recommendations and decisions.
• Strong leadership, influence, negotiation, and relationship-management skills, including the ability to navigate competing priorities and challenging partner discussions.
• People leadership experience and/or demonstrated experience building and developing program-management capabilities or teams strongly preferred.
• Advanced degree such as an MBA, MS, PhD, or equivalent in life sciences, business, engineering, or a related field preferred.
• PMP certification or equivalent program-management certification preferred.