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Imagine how your ideas and expertise can change a patient’s life. The Clinical Affairs team generates extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Manager, Clinical Portfolio Management (the formal Edwards title is Manager, Clinical Affairs) will manage the global clinical portfolio roadmap, monthly clinical program reviews and quarterly resource planning/AOP processes for the THV Clinical Affairs organization.

This role can be a hybrid or onsite role based at Edwards’ corporate headquarters in Irvine, California.

How you will make an impact:

• Support development, review and updates to a multi-year clinical portfolio roadmap with input from key stakeholders across THV business unit (e.g. Clinical Affairs, PMO, Finance, etc.) to facilitate portfolio planning and execution.

• Lead the monthly clinical program reviews including consolidation and distribution of project dashboards, detailed reviews of key milestones, timelines, deliverables, risks and issues with clinical program leadership and tracking and follow-up of action items.

• Manage the quarterly resource planning process and AOP process as it relates to resource planning. This includes driving all communication to people managers, resolving system issues, responding to change requests, and providing leadership insights into resource planning through analyses/reporting.

• Suggest continuous process improvement activities and course alignment opportunities including evaluations of new systems and/or procedures as needed.

• Other duties assigned by leadership

What you’ll need (Required):

• Bachelor's Degree or equivalent in a scientific or related field and 8 years of related work experience, OR

• Master's Degree or equivalent in a scientific or related field and 6 years of related work experience

What else we look for (Preferred) :

• Relevant clinical trial experience in medical device, biotech or pharma industry

• Cardiology related experience -- i.e., heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure – is highly preferred

• Proven clinical project/program management or clinical portfolio management experience

• Proficient in Microsoft Office Suite and related tools and systems (e.g., Medidata suite of products)

• Ability to synthesize and communicate to senior management key project aspects

• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Ability to establish relationships and manage communications with key clinical and business functions

• Ability to work positively through confrontation and/or conflicting ideas

• Understanding of clinical regulations/guidelines while looking beyond existing methodologies and own discipline to define and resolve complex problems

• Understanding and application of industry best practices

• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical affairs to the business

• Serves as a partner to leaders in Business Units, Functional Groups, and Regions

• Strict attention to detail

• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

• Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment

• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness

• Develop relationships and leverage them to influence change

• Support and solicit input from team members at all levels within the organization

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California, the base pay range for this position is $120,000 to $170,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.