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.How you will make an impact:
Develop and lead in the implementation of complex clinical trial device and procedural strategies, working closely with both the internal clinical operations team and the research staff across the external clinical sites
Plan complex activities with large scale or significant business impact with the accountability for successful completion of all clinical trial deliverables related to start-up and enrollment activities (e.g., physician training, device management, case performance and study enrollment). Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross-functional teams
Manage and oversee the work of team including other managers and/or experienced SMEs. Develop a robust talent development plan in alignment with functional growth strategies of the department
Lead global projects in support of clinical trial and/or device knowledge transfer (e.g., cross-training with regional teams). Develop processes and training plans to ensure compliance for IDE level studies
Represent Clinical Specialist team as the SME for cross-functional team alignment with therapy development, medical affairs, and R&D
Proctor clinical cases across early feasibility through pivotal trials
What you will need (Required):
Bachelor’s degree
A minimum of 10 years related experience
A minimum of 3 years people leadership experience
Experience in Class II and III medical device technologies and/or clinical studies background
Previous experience in proctoring clinical trial cases
Ability to travel up to 80% (domestic & international)
What else we look for (Preferred):
Master’s degree
Prior clinical experience in cath lab and/ or relevant certifications as a clinical device specialist
Relevant clinical trial executions experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure area
Expert understanding of clinical studies procedures while identifying applications of functional knowledge and existing methodologies to complex problems
Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
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 $188,000 to $267,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.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.