Associate Director/Director, Project Management

Experience • 8+ years of project or program management experience, • Demonstrated experience tracking product development programs under design control from early feasibility through clinical validation and regulatory submission • Hands-on experience with both molecular diagnostic and companion diagnostic programs strongly preferred • Proven track record of managing multiple complex programs simultaneously in a cross-functional environment Technical & Domain Knowledge • Working knowledge of product development lifecycle stages and strong working knowledge of software development lifecycle stages • Familiarity with regulatory frameworks relevant to IVD development, including CLIA/CAP for LDTs and FDA IVD approval and clearance pathways is preferred • Understanding of molecular diagnostic technologies (e.g., PCR, NGS, cfDNA-based assays) and the unique development and validation considerations they entail Skills & Competencies • Exceptional organizational skills with a track record of bringing structure and clarity to complex, multi-workstream programs • Strong communicator with the ability to translate technical program details into clear, concise updates for executive and cross-functional audiences • Highly collaborative with the ability to build trust and influence without direct authority across scientific, clinical, regulatory, and commercial teams • Proficiency with project management tools (e.g., Smartsheet, MS Project, Asana, or equivalent) and program tracking methodologies • Comfort operating in a fast-paced, resource-constrained environment with a bias toward action and continuous improvement • Entrepreneurial mindset with the resilience and adaptability to thrive in an early-stage company setting Education & Preferred Qualifications • Bachelor's degree required; Advanced degree preferred (MBA, MS, or PhD) in life sciences, molecular biology, business, or a related field • PMP certification or equivalent project management training preferred • Experience in a high-growth or early-stage IVD or diagnostics company is a plus • Exposure to reimbursement and commercial launch planning activities a plus
Program Planning & Tracking • Partner with early development leads and biomarker development leads to build and maintain comprehensive project plans with clear milestones and deliverables. • Own and manage integrated program timelines across multiple concurrent programs, ensuring milestones are clearly defined, dependencies are mapped, and critical path activities are actively managed • Track project progress, centralize resource planning and prioritization across the program. • Establish and maintain a centralized program tracking system that provides real-time visibility into program status across the portfolio • Prepare and deliver regular program status updates, executive dashboards, and portfolio reviews for senior leadership Cross-Functional Coordination • Serve as the primary point of coordination across R&D, Clinical Affairs, Regulatory, Quality, Commercial, and Operations teams to ensure alignment on program priorities and deliverables • Facilitate prioritization reviews and decision-making forums, ensuring the right stakeholders are engaged to make prioritization decisions. • Proactively identify risks, issues, and resource constraints across programs and drive resolution through structured problem-solving and escalation as needed • Coordinate cross-functional team meetings, author meeting agendas and minutes, and hold teams accountable to action items and commitments Process & Standards • Support the development and continuous improvement of project management processes, tools, and templates for project and program management. • Help define and enforce project prioritization criteria and concept/feasibility development phase definitions across molecular diagnostic and companion diagnostic program types • Drive adoption of project management best practices across the development organization, coaching functional leads on planning and accountability tools