Senior Manager, Clinical Safety

Edwards Lifesciences • Irvine, CA

21h • Onsite

About The Position

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Clinical Safety will manage a team of clinical research professionals providing oversight, mentoring and guidance to drive results in support of safety related activities within the Transcatheter Heart Valve business unit. This role requires onsite presence at our corporate headquarters in Irvine, CA.

Requirements

• Bachelor's Degree in in related field, with 5-7 years previous related experience or equivalent work experience based on Edwards criteria
• Demonstrated track record in people management or equivalent work experience based on Edwards criteria

Nice To Haves

• Master's Degree or equivalent in related field
• Experience in Medical device or pharmaceutical industry, Clinical research, or in-hospital clinical and/or managerial experience or equivalent work experience based on Edwards criteria
• Experience working in a regulated industry or equivalent work experience based on Edwards criteria
• Demonstrated ability to manage assigned team 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
• 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
• Good understanding of related aspects of clinical studies processes and/andor systems
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value to the business

Responsibilities

• Manage and oversee the work of the clinical safety team, providing oversight and guidance cross functional or matrix teams as appropriate.
• Develop a robust talent development plan in alignment with functional growth strategies of the department
• Develop and ensure alignment of safety processes (e.g., safety work instructions and documents, SOPs, charters) as needed.
• Identify risk, develop and lead in the implementation of clinical safety strategies which may include negotiations with internal and external parties
• Act as a liaison to key cross-functional stakeholders (e.g., PMO, Clinical Affairs, Regulatory Affairs, Quality, study sites leadership) regarding Safety-related matters
• Provide input on clinical trial design and safety sections of study protocols, CRFs, regulatory submissions, and clinical/regulatory reports and provide input to regulatory affairs questions on safety related issues
• Represent safety in internal and external audits

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families

What This Job Offers

• Job Type: Full-time
• Career Level: Senior