Edwards Lifesciences Manager, Medical Affairs - Transcatheter Mitral & Ticuspid Therapies (USA Remote Position) in Irvine, California
This is a unique opportunity to play a critical role in the growth of new cutting-edge heart valve therapies for Mitral & Tricuspid Valve Repair and Mitral Valve Replacement. We are seeking talented and passionate professionals to join this fast-paced, dynamic team and play a pivotal role in the development of new therapies and devices, from concept through to human use.
As a key member of the Medical Affairs, Clinical Science & Biometrics team, this individual will provide scientific expertise in the development of clinical trial strategy, clinical study design, clinical evaluation reports, clinical study protocols, risk management, and /or clinical studies in alignment with the TMTT business strategy. Through extensive interaction with clinician thought leaders (KOLs) along with a strong diverse cross-functional leadership team within the organization, this individual will have opportunities to make strategic and scientific impact on our current and future clinical portfolio.
The Manager will be an experienced medical device professional with strong scientific acumen and a commitment to putting patients first.
Responsible for alignment with trial leaders, TMTT’s Biometrics, Regulatory Affairs, Global Healthcare Economics and Reimbursement (GHER), Marketing, Strategy and Quality.
Work closely with the Director of Clinical science and cross-functional teams to identify clinical evidence study opportunities and priorities.
Create a strategic map of relevant clinical study evidence by parameter / product.
Develops clinical evaluation plans (CEP), clinical evaluation reports (CERs), clinical trial protocols (pre- and post-market) and other scientific documents (as appropriate).
Subject matter expert for guidelines and regulations regarding the clinical evaluation process.
Provide review and input to clinical and scientific aspects of regulatory filings, including technical summaries, labeling statements, IFU, Clinical Study Reports, Annual Progress Reports, and Clinical Evaluation Reports.
Collaborate with internal regulatory experts to ensure compliance with schedules for PMAs/IDEs and EU submissions.
Work with biometrics and other cross-functional team members in the review and interpretation of data.
Partner with GHER for study design to support reimbursement in major markets.
Develop an effective working relationship with multiple internal stakeholders including Clinical Affairs, Regulatory Affairs, Program Management, Research and Development, Quality and Marketing.
Develop a strong working relationship with various healthcare professionals including KOLs.
Collaborate and partner with Legal and Compliance as well as other key cross functional business partners.
Perform all responsibilities in full compliance with regulatory requirements, legal requirements, and industry guidelines.
Supervisory Responsibilities: Provides leadership and mentoring to relevant staff.
Education & Qualifications:
PhD in Science or related field with 6 years of related work experience; OR Master's degree in Science or related field with 8 years of related work; OR Bachelor’s in Science or related field with 10 years of related work experience
Extensive knowledge and hands-on experience supporting clinical sciences including clinical trial design, protocol development, endpoint selection and biostatistics is required.
Strong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulations is highly desirable.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.