Edwards Lifesciences Manager, Clinical Therapy Development (Field US) Surgical in San Diego, California
Edwards has an exciting opportunity with our Surgical Structural Heart group, focused on transforming patients' lives by advancing innovations in minimally invasive mitral valve repair.
The Manager, Therapy Development drives alignment, adoption and execution of clinical trial therapy development initiatives. This is a subject matter expert, individual contributor role.
Key Responsibilities including but not limited to :
Identify restrictions to patient access to clinical trials within a region’s geography
Evaluate and identify creative sources and solutions that can help inform and influence the strategic business plan for patient outreach initiatives (e.g., recruitment events) to drive adoption and trial enrollment along the clinical trial
Establish an understanding of referral dynamics and how patient access may be restricted or delayed within the clinical trial pathway
Leverage existing relationships with HCPs and KOLSs (e.g., physicians and research coordinators) through regular outreach and education activities, referring HCP visits, product demonstration and conference participation within the clinical research
Define areas of opportunity along the Heart Team’s referral pathway to maximize their patient access to key clinical trials
Identify and develop new relationships with HCPs (e.g., physicians and key staff) through constant communication, regular meetings and educational activities, (e.g. trial overview presentations, conference participation)
Recognize restrictions to, protocol adoption, clinical trial awareness, and develop specific strategies with site research team to meet those challenges
Support the development of HCP- and patient-directed materials and websites
Provide extensive support for patient selection, screening, imaging, and clinical data
Build timelines and key deliverables to align with overall business objective
Identify and differentiate root cause of patient access limitations between outreach and patient pathway; accurate tracking and documentation of all activity per clinical trial guidelines
Provide guidance on a variety of projects including identifying trial site specific bottlenecks and work with clinical affairs to refer to cross-functional partners (e.g., training, trial management, screening, case support etc.)
Advocate for the clinical site and sponsor, (EW). Collaborate across business units identifying opportunities to improve site or sponsor processes through consistent communication. Support and implement solutions to identified issues
Bachelor's Degree or equivalent four (4) year clinical degreein Life Sciences or related field
A minimum of 10 years of experience as a Clinical Specialist, Therapy Development Specialist, Clinical Education, medical device sales representative with implantable experience or equivalent combination
Ability to travel up to 75% domestically for site visits with the ability to manage travel schedules
Interventional cardiology or cardiac surgery industry experience
Structural heart sales experience
Familiarity with clinical research trials, applicable regulations, and industry compliance
Working knowledge of Microsoft tools, including Excel, SharePoint and MS TEAMS
For Colorado Residents Only:
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.
The base pay range for this position is $149,000.00 to $173,000.00.
Additional information can be found through the link below:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards 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 or have a valid religious or medical exemption from being vaccinated.
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.
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