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Director, CDx & Clinical Trial Portfolio Management

🔥 3 minutes ago

🇺🇸 United States – Remote

đź’µ $184.6k - $230.7k / year

⏰ Full Time

đź”´ Lead

đź‘” Director

🦅 H1B Visa Sponsor

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Natera

1001 - 5000 employees

Founded 2004

🏥 Healthcare

🧬 Biotechnology

⚕️ Healthcare Insurance

Healthcare • Biotechnology • Healthcare Insurance

Natera is a global leader in cell-free DNA testing technology, specializing in non-invasive genetic testing and diagnostics. The company's innovative solutions focus on areas such as prenatal screening, cancer detection, and organ transplant monitoring. By using advanced bioinformatics and DNA analysis, Natera provides healthcare professionals and patients with critical information to make more informed medical decisions.

đź“‹ Description

• Lead portfolio management across active and pipeline pharma CDx partnerships, maintaining an integrated view of commitments, milestones, dependencies, risks, resource needs, and upcoming decisions • Evaluate new CDx opportunities before commitments are made, assessing scope, deliverables, development and regulatory requirements, timelines, true cost-to-deliver, resource and capacity needs, dependencies, assumptions, and portfolio impact • Develop and maintain a forward-looking view of CDx and clinical-trial demand, capacity, and resource needs • Identify cross-program conflicts and tradeoffs and recommend prioritization, sequencing, resource allocation, and timing • Lead PMO portfolio review of incoming clinical-trial opportunities and assess requirements, feasibility, complexity, resources, cost, dependencies, operational readiness, and required PM support • Establish scalable portfolio-management and governance models for non-standard clinical-trial requirements • Provide portfolio-level oversight across pharma partnerships and establish consistent partner-program governance • Integrate external commitments with executable internal plans across Product, R&D, Clinical, Regulatory, Quality, Operations, Software/Bioinformatics, and other functions • Establish portfolio-level reporting, risk and decision management, escalation mechanisms, and regular portfolio reviews for leadership • Build scalable portfolio-management processes, tools, operating models, resource forecasting, risk-management, and decision-making frameworks • Build and lead the CDx and clinical-trial portfolio-management capability, including management and development of PM talent

🎯 Requirements

• Significant leadership experience in CDx/IVD program management, portfolio management, partnership management, or development management 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 • Experience evaluating and operationalizing new CDx opportunities, including scope, feasibility, timelines, costing/budgeting, resource planning, and capacity assessment • Experience managing 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 • 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 • People leadership experience and/or 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

🏖️ Benefits

• Comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents • Free testing for Natera employees and their immediate families • Fertility care benefits • Pregnancy and baby bonding leave • 401k benefits • Commuter benefits • Employee referral program

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