The OpportunityWe are seeking a highly organized and experienced Associate Director or Director of Project Management to join our growing Product Development team. This role bridges strategy and execution, managing the team through research, feasibility designs and customer presentations and ensures early-stage innovations align with business objectives. The ideal candidate brings hands-on project management experience from a leading in vitro diagnostics company and has a strong understanding of the technical, regulatory, and commercial complexities of bringing diagnostic products to market.
Who You AreExperience- 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
What You'll DoProgram 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
$180,000 - $240,000 a year
Associate Director: $180,000 - $220,000
Director: $215,000 - $240,000
Final compensation will be based on a candidate's qualifications, experience, and geographic location. Employees are also eligible for performance bonuses, equity participation and comprehensive health benefits.
We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don't hesitate to apply!
