Associate Director, Strategic Program Management

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

📋 Description

• Oversee intricate IVD/CDx initiatives throughout their development, design transfer, validation, and PMA submission processes.

• Create and uphold comprehensive program plans that encompass deliverables, resources, dependencies, decision points, and regulatory milestones.

• Collaborate with functional leaders to establish objectives, development priorities, success metrics, and actionable plans.

• Proactively identify risks, recognize gaps and trade-offs, and facilitate prompt cross-functional decision-making.

• Set up program governance, ownership structures, escalation pathways, and accountability measures.

• Combine assay development, design controls, software and bioinformatics, analytical and clinical validation, laboratory implementation, and submission activities.

• Work alongside Regulatory Affairs and Quality teams on FDA interactions, relevant requirements, and PMA evidence needs.

• Manage assay modifications, comparability or bridging studies, and the transition to the final CDx configuration.

• Direct development-gate reviews and monitor evidence and documentation critical to submissions.

• Communicate program strategy, progress, risks, trade-offs, and recommendations to executive leadership.

• Convert complex scientific, operational, and regulatory challenges into data-supported options and decisions.

• Foster alignment among leaders, hold teams accountable, and escalate significant issues as necessary.

• Deliver internal program updates and decision support for colleagues managing external pharmaceutical partnerships.

⛳️ Requirements

• A Bachelor’s degree in life sciences, engineering, or a related field, or equivalent relevant experience.

• Over 10 years of progressive program or project management experience within molecular diagnostics, in vitro diagnostics, medical devices, biotechnology, or a related regulated sector.

• Direct experience in leading CDx or IVD development programs that encompass design controls, validation planning, and preparation for FDA submission.

• Proficiency in constructing and executing integrated plans across technical, clinical, regulatory, quality, software, and operational functions.

• Capability to lead senior cross-functional stakeholders, manage competing priorities, and achieve results without direct reporting authority.

• Experience in presenting complex programs, risks, and recommendations to executive leadership.

• Skill in linking technical decisions, resource requirements, regulatory evidence, and timelines to the overarching program strategy.

🏝️ Benefits

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

• Complimentary testing for employees and their immediate families.

• Fertility care benefits.

• Leave for pregnancy and baby bonding.

• 401(k) benefits.

• Commuter benefits.

• Employee referral program.