assistant clinical research coordinator - limited

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assistant clinical research coordinator - limited Jobs in Irvine

r&d lab technician iv

clinical research associate

Edwards Lifesciences

<div>Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
The Director, Program Management leads the strategic and operational oversight of all Cordella product-and-platform-related projects within the Edwards Implantable Heart Failure Management (IHFM) organization. This role ensures the effective deployment of project management methodologies across the product lifecycle-from concept through commercialization-while aligning with corporate strategy and regulatory requirements. This role ensures alignment with corporate objectives, regulatory standards, and market needs while optimizing resource allocation, budget utilization, and portfolio value.
How you will make an impact:
<ul><li>Portfolio Strategy &amp; Governance: Lead the development and execution of the enterprise-wide product portfolio strategy, for the Cordella system including the PAP sensor, implantation components, online Patient Management platforms, at-home monitoring accessories and apps. Establish governance frameworks for portfolio prioritization, investment decisions, and lifecycle management. Drive portfolio rationalization efforts to ensure alignment with strategic goals and market opportunities.
</li></ul><ul><li>Agile &amp; Hybrid Program Management: Champion Agile methodologies for software, firmware, mobile, AI ML, and cloud-based application development. Integrate Agile practices with traditional stage-gate processes to support hybrid development models. Ensure sprint planning, backlog grooming, and iterative delivery align with regulatory and quality standards.
</li></ul><ul><li>Budget Management: Own the portfolio-level budget planning and forecasting process. Monitor and report on budget performance across all projects and programs. Partner with Finance to ensure accurate tracking of capital and operational expenditures.
</li></ul><ul><li>Resource Planning &amp; Optimization: Lead resource capacity planning across the portfolio to ensure optimal allocation of talent and tools. Identify resource gaps and recommend hiring or outsourcing strategies. Implement tools and processes for real-time visibility into resource utilization.
</li></ul><ul><li>Program &amp; Project Execution: Oversee execution of complex programs involving hardware, software, and systems integration. Ensure consistent application of stage-gate processes and design control procedures. Drive schedule management and ensure on-time delivery of milestones and product launches. Manage concurrent development cycles across multiple platforms and technologies.
</li></ul><ul><li>Risk Management: Lead proactive risk identification, assessment, and mitigation planning across the portfolio. Facilitate risk reviews and escalation processes to ensure timely resolution. Integrate risk management into stage-gate reviews and executive reporting.
</li></ul><ul><li>Verification &amp; Validation (V&amp;V) Oversight: Ensure robust planning and execution of V&amp;V activities across all programs. Collaborate with Quality, Regulatory, and Engineering to align V&amp;V with compliance and product performance requirements. Monitor V&amp;V timelines and resource needs to avoid bottlenecks and delays.
</li></ul><ul><li>Cross Functional Leadership: Partner with R&amp;D, Product Management, Regulatory, Clinical, Quality, Manufacturing, Supply Chain, and Commercial teams to ensure integrated portfolio planning and execution. Facilitate executive reviews, drive strategic decisions, and ensure alignment between product development, clinical evidence generation, and market needs.
</li></ul><ul><li>Innovation &amp; Technology Integration: Partner with Data Science, AI/ML, and Engineering teams to integrate advanced analytics and intelligent features into product roadmaps. Support innovation pipelines and early-stage concept development through structured project intake and evaluation. Foster a culture of experimentation, rapid prototyping, and continuous learning.
</li></ul><ul><li>Team Leadership &amp; Development: Build and lead a high-performing team of project and program managers. Drive accountability, innovation, and continuous improvement while overseeing staffing, budgets, succession planning, coaching, and talent development.
</li></ul><ul><li>Elevate BU maturity level specifically in the multiples areas of project management (e.g., governance, resource management and project management knowledge)
</li></ul>What you will need (required):
<ul><li>Bachelor's Degree or equivalent in related field and direct experience in project and program management or equivalent work experience based on Edwards criteria.
</li></ul><ul><li>Hands on experience managing large to midsize projects and/or programs of increasing complexity
</li></ul>What else we look for (preferred):
<ul><li>Master's Degree or equivalent in related field and 10 -12 years of direct experience in medical device product development, project and program management
</li></ul><ul><li>PMP, PfMP, SAFE Certified or equivalent
</li></ul><ul><li>Proven success in managing complex portfolios and launching regulated products
</li></ul><ul><li>Strong leadership skills and ability to influence change
</li></ul><ul><li>Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
</li></ul><ul><li>Proven expertise in usage and implementation of project management systems
</li></ul><ul><li>Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
</li></ul><ul><li>Deep understanding of medical device regulations and development processes. Experience within a regulated environment
</li></ul><ul><li>Deep understanding of Agile, hybrid, and stage-gate methodologies. Familiarity with AI/ML, cloud platforms, and digital health technologies
</li></ul><ul><li>Expertise in portfolio management tools and processes
</li></ul><ul><li>Strong financial, analytical, and resource planning skills. Ability to lead in a matrixed, global environment
</li></ul><ul><li>Expert understanding and knowledge of procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems relevant to developing the strategy on enterprise-wide projects and charting the course of overall programs
</li></ul><ul><li>Expert in project and program management, including managing, guiding and mentoring project managers
</li></ul><ul><li>Excellent problem-solving, organizational, analytical and critical thinking skills
</li></ul><ul><li>Excellent understanding and work experience with project budgets and financial management
</li></ul><ul><li>Experience in facilitating change, including collaboration with management and executive stakeholders
</li></ul><ul><li>Ability to work with abstract ideas or situation and translate it into concrete plan and specific objectives
</li></ul><ul><li>Ability to interact with senior management, and others concerning matters of significance to the company
</li></ul><ul><li>Ability to develop relationships and leverage them to influence change
</li></ul><ul><li>Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health &amp; Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control. 
</li></ul> 
 
For California, the base pay range for this position is $159,000 - $226,000 (highly experienced).
 
 
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. 
 
 
 
 
 
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.</div>

Director, Program Management

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Director, Program Management