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):

• Bachelor's Degree in a related field with 10 years of related experience working in clinical  science or medical/scientific writing; OR
• Master's degree in a related field with 8 years of related experience working in clinical  science or medical/scientific writing; OR

What else we look for (preferred):

• Doctorate degree (PhD, MD, PharmD) with 8 years of related experience working in clinical  science or medical/scientific writing.
• Familiarity with the coronary interventional and/or structural heart environments and current treatment options or have other clinical and/or clinical trial experience.
• Experience in the application of MEDDEV 2.7/1 and EU MDR for clinical evaluations.
• Experience with FDA PMA applications.
• Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR, Japan PMDA, China NMPA) regulations.
• Experience working in a cross functional, collaborative environment and comfortable interacting with R&D engineers, regulatory specialists, statisticians, physicians, and support personnel.
• Excellent communication skills and experience influencing and guiding stakeholders.
• Recognized as an expert in own subject area with specialized depth within current or previous organization(s).
• Expert understanding of related aspects of clinical science and/or scientific/medical writing.
• Expert knowledge of regulatory requirements and study execution.
• Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously.
• Excellent oral and written communication skills.
• Demonstrated experience with maintaining current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge.
• Strong knowledge of statistical analyses, study design methodologies, and clinical trial protocol development.
• Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote, and Adobe Acrobat.
• Strong analytical, problem-solving, and scientific writing skills.

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.