Associate Director/Director, Project Management

Precede•Boston, MA

1d•$180,000 - $245,000

About The Position

We are seeking a highly organized and experienced Associate Director or Director of Project Management to join our growing IVD development team. This critical role serves as the operational backbone of our test development organization, partnering closely with IVD test development leads to plan, track, and drive all key development activities from Feasibility through Clinical Validation. The ideal candidate brings hands-on project management experience from a leading in vitro diagnostics company and has a deep appreciation for the technical, regulatory, and commercial complexities of bringing diagnostic products to market. About Us We are pioneering an advanced, minimally invasive, comprehensive epigenomics platform with the potential to profoundly impact the research and development of new medicines and the use of approved medicines in clinical practice across a number of conditions, including cancer. More information on our company and platform can be found on our company website and in our seminal publication in Nature Medicine. We care deeply about creating a place where folks can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, and collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.

Requirements

8+ years of project or program management experience, with at least 4 years in an in vitro diagnostics company of recognized scale and rigor
Demonstrated experience tracking IVD 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
Strong working knowledge of IVD development lifecycle stages, including Feasibility, Design & Development, Analytical Validation, Clinical Validation, and regulatory submission readiness
Familiarity with regulatory frameworks relevant to IVD development, including CLIA/CAP for LDTs and FDA IVD approval and clearance pathways
Understanding of molecular diagnostic technologies (e.g., PCR, NGS, cfDNA-based assays) and the unique development and validation considerations they entail
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
Bachelor's degree required; Advanced degree preferred (MBA, MS, or PhD) in life sciences, molecular biology, business, or a related field

Nice To Haves

Familiarity with companion diagnostic development requirements and pharma partnership dynamics is a strong plus
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

Responsibilities

Partner with IVD test development leads to build and maintain comprehensive project plans covering all stages of development, from Feasibility through Analytical Validation, Clinical Validation, and launch readiness aligned with 21 CFR Part 820 or ISO 13485 Design Control requirements.
Own and manage integrated program timelines across multiple concurrent IVD programs, ensuring milestones are clearly defined, dependencies are mapped, and critical path activities are actively managed
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
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 stage-gate reviews and decision-making forums, ensuring the right stakeholders are engaged at key program milestones
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
Support the development and continuous improvement of project management processes, tools, and templates appropriate for an IVD development environment
Help define and enforce stage-gate criteria and 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
Apply an understanding of pharma partner timelines and CDx development requirements to structure and track companion diagnostic programs in coordination with program leads and external partners
Manage program-level tracking of CDx collaboration deliverables, milestones, and reporting obligations to pharma partners