Sr Mgr, Program Mgmt BU Evidence

Edwards Lifesciences; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA seeks a Sr. Manager for the PMO of Evidence, TMTT. You will lead cross-functional clinical, medical and regulatory trial programs, plan, execute and drive business objectives.

This onsite role requires a strong background in project management within medical devices, PMO leadership, stakeholder coordination, and delivery of complex programs on time and within scope.

Qualifications

• Bachelor's Degree with 10+ years hands-on experience managing mid-to-large scale projects
• Master's Degree with 8+ years hands-on experience or equivalent Edwards criteria
• PMP training or certification strongly preferred

Responsibilities

• Plan multi-level, detailed project plans to meet clinical, medical and regulatory objectives.
• Manage large-scale project scope, schedule, risks, and deliverables across cross-functional teams.
• Lead cross-functional core team meetings and maintain discipline and accountability.
• Define/manage resource requirements to support program objectives.
• Maintain weekly status reports, timelines, and program dashboards.
• Influence strategic discussions and provide clarity on roles and responsibilities across stakeholders.
• Inform business planning and strategy through PMO leadership in concerned programs.
• Adhere to company rules and safety/environment protocols in all activities.

Skills

Project management

Cross-functional leadership

Stakeholder management

Risk management

Team leadership

PMP knowledge

Education

Bachelor's degree + 10+ years

Master's degree + 8+ years

Tools

MS Office Suite

Job description

Sr. Manager, Project Management BU PMO, Evidence, TMTT

Make a meaningful difference to patients around the world. Our project management teams support many parts of Edwards, including Engineering, HR, Marketing, IT, and more. You'll be a trusted thought leader as you ensure our projects are completed efficiently and effectively. Your strategic mindset and fresh perspectives will be an essential part of how we bring innovative solutions for patients.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient's unmet clinical needs. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Edwards has a unique opportunity to join the Transcatheter Mitral and Tricuspid Therapies (TMTT) division. As a Manager in the Clinical, Medical, and Regulatory Affairs Program Management Office, you will lead multiple cross-functional clinical trial programs and teams to plan, execute and drive business objectives.

Work Schedule: This is an onsite position in Irvine, CA.

How you'll make an impact:

• Planning: Develop multi-level, detailed project plans to meet clinical, medical and regulatory objectives based on cross-functional input and analysis. Build core team consensus and team ownership of the plan.
• Scope: Understanding of product development process, clinical trial milestones, and strategic objectives to drive a successful trial program.
• Determines and discerns requirements on large scale projects to establish project and program deliverables. Manages changes to the project scope and schedule, anticipates risks, builds various scenarios to drive decision making and agility.
• Performance Measurement and Risk Mitigation: Analyze performance to plan and develop corrective action plans for any variances with the core team. Identify forward looking risk and determine mitigation plans with core leadership team.
• Team Leadership: Lead cross-functional core team meetings. Build the following within the team: meeting discipline (agenda, minutes, action items) and team esprit de corps, problem solving culture and accountability.
• Resource Management: Partner with functional leads, cross-functional team members and other project managers to define/manage resource requirements to support program objectives.
• Communication and Reporting: Maintain weekly status reports, timelines, and program level dashboards. Proactively initiate efficient and effective communication, influence strategic discussions drawing on clinical knowledge, and provide clarity for roles and responsibilities to align stakeholders. Serve as conduit between project/team members in all cross-functional groups (e.g. Clinical, Marketing, Ops, Quality, R&D, Regulatory, Finance, Strategy, etc.)
• Strategy: Serve as a PMO lead in strategic conversations with senior internal and external personnel to inform business planning and strategy, and represent cross-functional team.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & 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 thei

What you'll need (Required):

• Bachelor's Degree with minimum 10 years hands on experience required in related field, managing mid-to-large scale projects or equivalent work experience based on Edwards criteria
• OR Master's Degree with 8 years of experience or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

• Clinical trial experience, particularly within the medical device industry
• Completion of project management training (PMP) strongly preferred
• Proficient with MS Office Suite and related project management systems
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Substantial understanding and knowledge of principles, theories, and concepts relevant to program and portfolio management
• Ability to quickly learn and adapt to new technologies, and dynamic, agile environment and teams
• Ability to work independently and as an active member and leader of the team
• Ability to address delicate situations, operate with tact and professionalism, and effectively manage conflict to maximize project team progress
• Ability to lead, motivate, and inspire teams to action to support business objectives
• Strong problem-solving, organizational, analytical and critical thinking skills
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Effectively communicate orally and in writing to all project stakeholders
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & 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 thei