Edwards Lifesciences Director, Global Safety – Transcatheter Heart Valve in Irvine, California
Joining Edwards Lifesciences means innovating, pushing boundaries and being creative while always putting patients first. It means solving challenges with colleagues who share your sense of urgency, optimism, and enthusiasm, colleagues who are just as focused on testing their limits and taking ownership. And it means that you will be empowered to get the job done by taking charge of your work, your health, and your career.
Innovation is at the core of Edwards! Without it, we would not be able to produce the life-saving products and therapies that transform lives around the world. That is why we surround ourselves with people who are not afraid to question the status quo or express a different point of view. Employees who feel passionate about the Edwards credo and dedication to community.
About the Role:
The Transcatheter Heart Valve (THV) clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
The Director, Global Safety - THV will provide leadership and clinical expertise in support of new product development and/or marketed products for the Transcatheter Heart Valve team.
Lead a large, global team of Medical Safety Officers and Safety Specialists in driving safety activities for all THV clinical trials
Serve as a primary strategic partner across senior leadership on scientific communication activities including the review and analysis of clinical data reports, presentations for Regulatory submissions, conferences, and study meetings (e.g., Executive Committees, DSMB, CEC, Steering Committees)
Provide strategic leadership in the identification of and development of new and significant existing KOL relationships
Effectively partner with senior leadership team to drive clinical trial success across multiple functions
Collaborate with R&D, Clinical Development, Quality and Complaints Handling, Regulatory, Physician Training, and outside vendors taking a proactive stance to ensure THV trials are addressing safety and risk appropriately
Work closely with cross-functional study teams to align the safety vigilance plans with existing regulations and ensure accuracy and relevancy of risk management with patient safety data, event adjudication, DSMB recommendations, and study endpoints.
Direct activities of multiple sub-functions through lower management levels while establishing functional area strategy, developing corporate and/or organizational policies and authorizing their implementation
Plan and direct multiple strategic, enterprise-level projects with highest criticality including serving as a source of escalation
Develop a robust strategic talent development and succession plan including the optimization and utilization of resources in alignment with functional growth strategies across the global clinical organization
Analyze, formulate, and present recommendations to advise and guide executive level leadership; develop and deliver executive level communication across functions that impact multiple areas of the business
Set overall global clinical trial strategy including efforts to optimize processes by assessing needs and developing, proposing, and leading implementations
Lead the safety assessment of the full portfolio of THV products in clinical evaluation
Develop safety strategy for the THV products in clinical studies including overview of safety assessments, identifying/analyzing safety signals and trends, creating and implementing safety processes and trainings and providing clinical safety expertise support for other departments
Develop CEC adjudication process and provides ongoing oversight of the workflow between CEC and Edwards as well as between Edwards and all clinical sites
Develop and Implement THV Safety Processes according to Regulatory Requirements, Edwards Lifesciences SOPs, and Ethical Obligation. Provide ongoing oversight of adverse event reporting, review, and timely adjudication for THV Clinical Studies
Ensure appropriate oversight of the safety profile of the THV product in clinical evaluation, including review of individual safety cases and aggregate reports, signal detection and evaluation, and escalated safety issues appropriately within the company
Oversee the on-time execution of clinical trials in accordance with global clinical processes, regulations and good clinical practices
A Master's Degree or a medical degree (US or OUS) with 10 years experience
5 years experience with a demonstrated track record in people management with ability to effectively lead and manage a diverse team across multiple geographies is required
Ability to travel 25% (domestic & international)
Experience working in a regulated industry
Experience in clinical strategy is required
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease, and congestive heart failure areas
Experience with Class III medical devices
Continuing education in clinical research monitoring or experience in clinical research
Experience in managing clinical trial steering committees
Experience in clinical, regulatory, and marketing aspects of medical device technology
You are a leader that provides your direct reports support, leads by example, and inspires your team to be the best they can be
You have strong communications skills and can influence various levels of professionals within the organization and outside partners
You can make calm, rational decisions in a fast-paced environment
You are passionate about our mission to provide innovative solutions for people fighting cardiovascular disease
You enjoy teamwork and collaborating as a means to build a stronger team and align on communication
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.