Senior Manager, Therapy Development TMTT

Senior Manager, Therapy Development TMTT

16 Aug 2024
North Carolina, Raleigh / durham / CH, 27601 Raleigh / durham / CH USA

Senior Manager, Therapy Development TMTT

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.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.How you will make an impact:

Identify restrictions to patient access 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) for the mitral and tricuspid patient along the clinical trial continuum in collaboration with stakeholders (e.g., physicians, research coordinators). Establish an understanding of referral dynamics and how patient access may be restricted or delayed within the clinical trial pathway

Develop new and existing relationships with HCPs (e.g., physicians and key staff) through regular outreach and education activities, referring HCP visits, product demonstration and conference participation within the clinical research

Develop HCP- and patient-directed materials to support strategic business plan in collaboration with clinical marketing

Provide technical expertise on devices/protocols and on-site support for patient selection, screening, imaging, Heart Team concept and clinical data across BU

Define areas of opportunity along the Heart Team referral pathway to maximize their patient access to key clinical trials

Identify, influence and meet with existing HCPs to identify clinical needs and constraints related to BU clinical trial protocol adoption

Build timelines and key deliverables to align with overall business objective

Provide technical 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 etc.)

Incidental: Identify and differentiate root cause of patient access restrictions between outreach and patient pathway ; Accurate tracking and documentation of all activity per clinical trial guidelines

What you will need (Required):

Bachelor's Degree or equivalent four (4) year clinical degree in Life Sciences or related field

10 years related experience

Ability to travel up to 70%

What else we look for (Preferred):

Nurse Practitioner or Physician Assistant in structural heart

Experience as a Clinical Specialist, Therapy Development Specialist, Clinical Education and/or equivalent within the interventional cardiology industry

Knowledge of clinical trials

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

Strong project management skills

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 $138,000 to $196,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.

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