Director, CDx & Clinical Trial Portfolio Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee portfolio management for active and prospective pharma CDx partnerships, ensuring a cohesive view of commitments, milestones, dependencies, risks, resource requirements, and forthcoming decisions.

• Assess new CDx opportunities prior to commitments, evaluating scope, deliverables, development and regulatory obligations, timelines, actual cost of delivery, resource and capacity needs, dependencies, assumptions, and impact on the portfolio.

• Create and sustain a proactive perspective on CDx and clinical trial demand, capacity, and resource necessities.

• Detect cross-program conflicts and trade-offs, and propose prioritization, sequencing, resource distribution, and scheduling.

• Spearhead PMO portfolio evaluations of incoming clinical trial opportunities, analyzing requirements, feasibility, complexity, resources, costs, dependencies, operational readiness, and necessary PM support.

• Develop scalable portfolio management and governance frameworks for non-standard clinical trial requirements.

• Offer portfolio-level oversight for pharma partnerships and implement consistent governance for partner programs.

• Align external commitments with actionable internal plans across Product, R&D, Clinical, Regulatory, Quality, Operations, Software/Bioinformatics, and other departments.

• Create portfolio-level reporting, risk and decision management systems, escalation procedures, and regular portfolio assessments for leadership.

• Establish scalable processes, tools, operating models, resource forecasting, risk management, and decision-making frameworks for portfolio management.

• Build and direct the CDx and clinical trial portfolio management capability, including the management and development of PM talent.

⛳️ Requirements

• Extensive leadership experience in CDx/IVD program management, portfolio management, partnership management, or development management across multiple intricate programs or pharmaceutical partnerships.

• Profound understanding of the CDx/IVD development lifecycle, encompassing development, analytical and clinical validation, regulatory strategy and submission, design transfer, and commercialization factors.

• Proven experience in evaluating and operationalizing new CDx opportunities, including scope, feasibility, timelines, budgeting, resource planning, and capacity evaluation.

• Experience in managing a portfolio of programs or partnerships while identifying cross-program dependencies, resource conflicts, portfolio risks, and trade-offs.

• Significant experience collaborating directly with pharmaceutical partners and senior/executive stakeholders, both internally and externally.

• Ability to engage across Business Development, Product, Clinical, Regulatory, R&D, Finance, Operations, Software/Bioinformatics, and other cross-functional teams.

• Experience in establishing scalable program and portfolio management structures, governance, and operational processes.

• Strong executive communication skills with the ability to distill complex program, resource, financial, and technical information into clear recommendations and decisions.

• Exceptional leadership, influence, negotiation, and relationship management abilities.

• Experience in people leadership and/or in building and developing program management capabilities or teams is highly preferred.

• An advanced degree such as an MBA, MS, PhD, or equivalent in life sciences, business, engineering, or a related field is preferred.

• PMP certification or a comparable program management credential is preferred.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability coverage for eligible employees and their dependents.

• Complimentary testing for Natera employees and their immediate families.

• Fertility care benefits available.

• Leave for pregnancy and baby bonding.

• 401k benefits offered.

• Commuter benefits included.

• Employee referral program available.