Senior Manager, Clinical Science, Medical Affairs

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives.

The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives. This is an exciting opportunity for an exceptional Clinical Scientist professional to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up.

How you'll make an impact :

• As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager, Medical Affairs) is responsible for providing scientific expertise throughout the development and implementation of clinical studies and clinical evaluations for a dynamic portfolio of products across TMTT. The Senior Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
• This position can be an onsite or a hybrid role based at Edwards Lifesciences’ corporate headquarters in Irvine, California, or can be a remote based role in the U.S.
• Contribute to strategy and planning of clinical science and medical writing deliverables.
• Lead clinical study design and clinical protocol development.
• Independently author complex documents including clinical study protocols (pre-market and post-market), clinical study reports, annual progress reports, post-approval study reports, clinical evaluation plans, clinical evaluation reports, post-market clinical follow-up plans and reports, and other scientific documents (as appropriate).
• Independently author complex regulatory responses.
• Perform systematic literature reviews from initiation to completion (develop search strategies, manage associated documentation, and prepare literature summaries).
• Independently review raw and summary clinical data for accuracy; resolve potential discrepancies.
• Interpret safety and effectiveness results from pre-market and post-market data sources; conduct systematic data appraisals to support overall benefit-risk assessments.
• Independently review and collaborate with cross-functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting.
• Summarize key data from clinical studies and published literature and provide updates to internal and external stakeholders (as appropriate).
• Ensure documents comply with regulatory guidelines.
• May travel up to 15% to attend scientific conferences.

What you’ll need (Required) :

What else we look for (preferred) :

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.