Edwards Lifesciences Senior Director, Global Safety – Transcatheter Heart Valve in Irvine, California
The Senior Director, Global Safety will provide leadership and clinical expertise in support of new product development and/or marketed products.
Direct activities of multiple sub-functions through lower management levels while establishing 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
Oversee the on time execution of clinical trials in accordance with global clinical processes, regulations and good clinical practices
Effectively partner with senior leadership team to drive clinical trial success across multiple functions
Provide strategic leadership in the identification of and development of new and significant KOL relationships
Strategic partner across senior leadership on scientific communication activities: clinical data reports, presentations for Regulatory submissions, conferences and study meetings (e.g., Executive Committees, DSMB, CEC, Steering Committees) and ensure accuracy and relevancy.
Develop a robust strategic talent development and succession planning 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
Other incidental duties
Education and Experience:
A Bachelor's Degree in a scientific discipline is required; Experience in clinical strategy is required
Demonstrated track record in people management with ability to effectively lead and manage a diverse team across multiple geographies is required
Master’s degree, PhD, or other advanced degree is preferred; Experience working in a regulated industry is preferred;
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas strongly preferred
Experience with Class II & III medical devices preferred, documented current continuing education in clinical research monitoring or experience in clinical research
Experience in managing clinical trial steering committees preferred
Experience in clinical, regulatory and marketing aspects of medical device technology is preferred
Proven successful project management leadership skills with ability to meet deadlines on multiple projects
Proficient in Microsoft Office Suite and related tools and systems (e.g., CTMS)
Excellent facilitation and presentation skills
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Ability to establish relationships and manage communications with key clinical customers (e.g., physicians, nurses, administrators)
Ability to work positively through confrontation and/or conflicting ideas
Expert understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, CFR 820, Canadian Medical Device Regulation (CMDR), EU MDD/MDR) while looking beyond existing methodologies and own discipline to define and resolve complex problems
Excellent financial and business acumen
Expert understanding and application of industry best practices
Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of clinical affairs to the business
Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions
Knowledge of biostatistical and actuarial methods
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
Interacts internally and externally with executive level management, requiring negotiation of extremely critical matters; influences policymaking
Dedicated to quality client service and pro-active and responsive to client needs
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels within the organization
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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.