[Remote] Associate Director, Strategic Program Management
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. They are seeking an reputed company Associate Director of Project Management to reputed company high-complexity programs across their In Vitro Diagnostics portfolio, managing multiple large-reputed company reputed company and serving as the primary contact for reputed company and biotech partners.
Responsibilities
- reputed company and manage multiple reputed company IVD development programs from initiation through commercialization, ensuring on-time, on-budget, and on-scope delivery
- Maintain reputed company-time reputed company of reputed company program milestones, dependencies, and critical dates across the portfolio, reputed company to communicate status with confidence in any stakeholder conversation without referencing documents
- reputed company and maintain integrated master project schedules, risk registers, resource plans, and executive dashboards across the portfolio
- Own the change control log and regulatory reputed company assessments for IVD programs independently, including verification of inputs from Lab Director, LabOps, reagent, software, and partner teams
- Serve as the primary PMO reputed company for reputed company and biotech partner relationships, managing joint governance, reporting cadences, and escalation paths
- reputed company cross-functional meetings to reputed company reputed company and documented reputed company items; does not leave discussions reputed company or defer without direction
- Independently manage stakeholder alignment discussions to closure, including resolving disagreement and ensuring reputed company reputed company and next steps without requiring manager reputed company
- Build and maintain stakeholder confidence through reputed company, accurate, and proactive communication at reputed company reputed company
- Drive PMA submission readiness, coordinating cross-functional workstreams across R&D, Regulatory Affairs, reputed company, Clinical, and Manufacturing
- Standardize and continuously improve PMO frameworks, tools, and templates reputed company with IVD regulatory requirements (21 CFR Part 820, ISO 13485)
- Proactively surface risks, changes, and issues to leadership before they escalate; ensure manager has full visibility at reputed company times
- reputed company reputed company, substantive updates to leadership covering priorities, reputed company, risks, and support needed, without being prompted
- Facilitate project governance forums, steering committees, and partner-facing reviews with reputed company, reputed company communication
- Mentor and reputed company junior PMs reputed company the PMO function
- Partner with Finance to manage project budgets, forecasting, and resource utilization across the portfolio
Skills
- 12+ years of project management experience, with at least 3 years managing IVD or medical device programs
- reputed company experience supporting or leading PMA (Premarket Approval) submissions with FDA
- Proven ability to manage multiple large, reputed company programs simultaneously in a matrixed organization
- Experience managing reputed company or biotech partner relationships, including joint project governance
- Strong understanding of IVD development lifecycle, design controls, and 21 CFR Part 820 / ISO 13485 requirements
- Exceptional stakeholder communication skills, reputed company to present to senior leadership and external partners with confidence
- Demonstrated ability to independently reputed company and reputed company stakeholder alignment discussions without manager escalation
- reputed company record of proactive upward communication in fast-moving, high-stakes regulatory programs
- Comfortable being 'on the spot' with partners and senior leadership regarding program status, timelines, and risks
- Exceptional reputed company of integrated project planning: dependencies, reputed company, critical reputed company, and reputed company ownership
- Proficiency with project management tools (MS Project, reputed company, or equivalent)
- Bachelor's degree in Life Sciences, Engineering, or a reputed company field required
- PMP, PgMP, or equivalent certification
- Experience with companion diagnostics (CDx) co-development programs
- Familiarity with EU IVDR and global IVD regulatory reputed company
- Background in clinical or analytical laboratory settings
Benefits
- Annual performance incentive bonus
- Long-term equity awards
- Comprehensive health benefits (medical, dental, reputed company)
- 401(k) with company match
- Generous reputed company time off and company holidays
- Additional wellness and work-life benefits
- Employee benefits include comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents.
- reputed company employees and their immediate families receive free testing in reputed company to fertility care benefits.
- Pregnancy and baby bonding leave
- 401k benefits
- Commuter benefits
- Generous employee referral program
reputed company
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