Director, Medical Safety Officer

Edwards Lifesciences • Irvine, CA

2d

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 Director, Medical Safety Officer will contribute by setting and/or directly influencing the medical safety officer strategy and accomplishing objectives through leading the work of direct reports who exercise significant latitude and independence. You will make an impact by:

Manage and oversee the work of medical safety officers, including analysis of safety data and signal detection, complex clinical risk/benefit analysis, and input on clinical/regulatory documents
Develop a robust talent development plan in alignment with functional growth strategies of the department.
Identify risk, develop and lead in the implementation of broad and more complex medical safety strategies, which may include negotiations with internal and external parties
Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables.
Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams
Analyze highly complex adverse events reported through clinical studies
Oversee CEC and DSMB/DMC process, including training and quality assurance of adjudication results and output
Provide input on clinical trial design and develop safety sections of study protocols, regulatory submissions, and clinical/regulatory reports
Represent safety in internal and external audits
Represent safety in cross-functional and core team meetings
Develop and lead the implementation of safety processes according to applicable regulatory requirements

Requirements

• Master's Degree or equivalent Physician Assistant (PA) with a Master's degree in Physician Assistant Studies (MPAS), Health Science (MHS), or Medical Science (MMSc) or Nurse Practitioner (NP) with a Master's of Science in Nursing (MSN) -OR- advanced practice registered nurse (APRN) or equivalent -OR- M.D, DO, PhD or equivalent relevant medical/clinical and relevant industry experience
• Demonstrated track record in people management

Nice To Haves

• Experience working in a regulated industry
• Certification in related fields
• Proven successful project management leadership skills
• Proficient in Microsoft Office Suite and related tools and systems
• 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 KOLs and clinical personnel with ability to drive achievement of objectives
• Ability to translate complex and technical information to project team management and key leadership
• Expert understanding of procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Expert knowledge of cardiovascular anatomy, pathology and physiology
• Expert understanding of medical device regulatory requirements, related documents and reports
• Extensive knowledge of global adverse events reporting
• In-depth understanding of corporate/global procedures, standard operating procedures, and writing practices
• Demonstrated ability to manage one or more 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 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
• Frequently interacts with internal and external management and senior-level stakeholders concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Lead briefings and technical meetings for internal and external representatives
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
• 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 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
• Aligning our overall business objectives with performance

Responsibilities

• Manage and oversee the work of medical safety officers, including analysis of safety data and signal detection, complex clinical risk/benefit analysis, and input on clinical/regulatory documents
• Develop a robust talent development plan in alignment with functional growth strategies of the department.
• Identify risk, develop and lead in the implementation of broad and more complex medical safety strategies, which may include negotiations with internal and external parties
• Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables.
• Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams
• Analyze highly complex adverse events reported through clinical studies
• Oversee CEC and DSMB/DMC process, including training and quality assurance of adjudication results and output
• Provide input on clinical trial design and develop safety sections of study protocols, regulatory submissions, and clinical/regulatory reports
• Represent safety in internal and external audits
• Represent safety in cross-functional and core team meetings
• Develop and lead the implementation of safety processes according to applicable regulatory requirements

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: Director