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Imagine how your ideas and expertise can change a patient’s life. We generate 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.

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.

As Vice President, Clinical Affairs for Edwards’ Implantable Heart Failure Management (IHFM) business unit, you provide strategic leadership and clinical expertise to drive clinical trial success and regulatory approvals for innovative heart failure technologies, including the Cordella system. You are responsible for setting and executing the US clinical strategy, ensuring compliance with global standards, and integrating biostatistics into clinical development to support expanded indications, labeling and reimbursement.

How you’ll make an impact:

+ Lead development and execution of US clinical strategy for IHFM products, aligning with global regulatory and business objectives

+ Oversee all aspects of clinical trial operations including protocol design, CRO/vendor management, site monitoring and patient recruitment

+ Ensure compliance with FDA regulations, GCP, international standards, and Edwards’ quality systems

+ Direct premarket and post-approval clinical studies, including biostatistical analysis and reporting

+ Collaborate with cross-functional teams and external stakeholders (KOLs, advocacy groups, regulators) to support clinical and scientific communication

+ Provide strategic oversight of clinical data generation, including authoring protocols, ICFs, CSRs, and regulatory documentation

+ Lead biostatistics strategy, including complex data analysis, risk mitigation, and statistical recommendations for executive leadership

+ Drive talent development, succession planning, and resource optimization across the clinical organization

+ Set and manage clinical trial budgets and timelines, ensuring on-time execution and high-quality deliverables

+ Represent clinical affairs in executive-level decision-making and strategic planning across the enterprise

What you’ll need (Required):

+ Bachelor’s degree in a scientific or related discipline required

+ Proven experience in clinical strategy and team management across geographies within a regulated industry

+ Extensive experience in clinical trial design, execution, and regulatory submissions (IDE, CE, PMA)

+ Deep knowledge of GCP, FDA regulations, and international clinical research standards

+ Strong proficiency in biostatistics, including complex methodologies and data interpretation

+ Excellent communication skills for engaging with KOLs, regulators, and internal stakeholders

+ Experience with Class II & III medical devices and heart failure-related clinical trials

+ Familiarity with EDC systems, CRF design and clinical data management principles

+ Strategic mindset with ability to influence and guide executive-level decisions

What else we look for (Preferred):

+ Advanced degree (Master’s, PhD, MD)

+ Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas strongly

+ Demonstrated success in managing steering committees and cross-functional clinical teams

+ Experience in clinical, regulatory and marketing aspects of medical device technology

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.