Edwards Lifesciences Director, Global Safety (Irvine, CA) – Transcatheter Heart Valve (THV) in Irvine, California
Director, Global Safety (Irvine, CA) – Transcatheter Heart Valve (THV)
Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.
The Safety Director leads the safety assessment of the full portfolio of THV products in clinical evaluation globally. In this position you will develop safety strategy and for the THV products in clinical studies including overview of safety assessments, identifying/analyzing safety signals and trends, creating and implementing safety processes and training's and providing clinical safety expertise support for other departments.
This role is located in and based out of Irvine, CA
Essential Job Functions/Key Responsibilities:
Supervise safety medical officers in carrying out safety data review and analysis and providing safety input on key regulatory or clinical documents (CSRs, protocols, etc.).
Develops Clinical Events Committee (CEC) adjudication & Data Safety Monitoring Board (DSMB) processes and provides ongoing oversight of the workflow between the CEC, DSMB and Edwards as well as between Edwards and all clinical sites.
Development and implementation of global THV Safety processes according to regulatory requirements, Edwards SOPs and ethical obligations
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
Assessment of adverse event reports and analysis for clinical, regulatory and complaint handling submissions, in compliance with worldwide reporting requirements (e.g., expedited UADEs, aggregate reports and other regulatory documents as requested)
Cross-function cooperation with Clinical Affairs, Regulatory Affairs, Quality, R&D and Marketing regarding all aspects of safety assessment of the THV Products in clinical studies and post-market registries
Contribute to Safety protocol design, submissions, reports, clinical summaries, updates and other
Represent THV on safety aspects for the product externally, engagement with DSMBs CEC, EC, preparation for and attendance at regulatory authority meetings, interactions with external advisers or opinion leaders
Facilitate talent management activities to include hiring, training, staff development and succession planning
Develop and facilitate safety training to include creation of materials for EW team and sites
Establish CEC & DSMB adjudication and review processes and workflows including charters and workflow between Edwards and the CEC & DSMBs
M.D. (or equivalent OUS medical degree) is required.
Will consider advanced practice clinician (N.P. or P.A.) with strong cardiothoracic or interventional experience.
At least 5 years of global industry experience with device/drug safety is required or more than 10 years of industry experience with clinical trials.
Minimum of 3 years in clinical practice
Knowledge of global safety regulations, principles of device development and safety assessment of devices both on the market and in clinical development is required.
Experience and knowledge of Good Clinical Practices and Pharmacovigilance regulatory requirements in US, the EU and globally is required.
Preferred Qualifications: In addition to meeting minimum requirements, it would be nice to have the following:
Internal medicine/cardiology/cardiac surgery preferred
Class III Medical Device experience preferred
Pre-clinical experience a bonus!
Additional Talents and General Expectations:
Comprehensive understanding of medical terminology and familiarity with principles of clinical assessment of ADEs
Comprehensive knowledge of medical device regulatory documents/ device accountability/ adverse events reporting including the US Code of Federal Regulations (CFR) 820, Canadian Medical Device Regulation (CMDR), EU Medical Device Directives, Japan PMDA Medical Device reporting directives, and China NMPA Medical Device reporting directives.
Ability to communicate and relate well with members of the Clinical Events Committee (CEC) and members of the Data Safety Monitoring Board (DSMB), study investigators and supporting staff
Demonstrable excellent written and verbal communication skills, presentation skills, interpersonal skills and analytical skills are a must
Substantial computer literacy
Must have the ability to travel up to 30% of the time, with occasional international travel
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 13,000 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.