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Edwards Lifesciences Director, Clinical Trials Management (Irvine, CA) – Structural Surgical Heart in Irvine, California

Director, Clinical Trials Management (Irvine, CA) – Structural Surgical Heart

Have you been searching for a role that brings you to the forefront of innovation? Edwards has an exciting opportunity with our Surgical Structural Heart group, focused on developing new and maintaining the best standard of surgical and minimal invasive treatments for patients suffering from heart valve disease.

As the Director - Clinical Trial Management (internally titled as Director, Clinical Program Management), you will be responsible for the clinical trial management of multiple studies and subject matter expert for assigned clinical studies. Responsibilities include planning, execution, implementation, oversight and project management to ensure completion of clinical trials. This position oversees a team that conducts the day-to-day activities required to advance each clinical trial to successful, on-time completion.

This role is based in Irvine, California. Comprehensive relocation package is available.

Essential Job Functions/Key Responsibilities:

  • Direct clinical trial activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending, and implementing changes to methods through several managers.

  • Develop a robust talent development and succession planning in alignment with functional growth strategies across the organization

  • Lead in identifying, mitigating, and eliminating risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams which includes negotiations with internal and external parties

  • Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives.

  • Analyze, formulate and present recommendations to advise and guide executive level leadership; develop and deliver executive level communication

  • Present trial information at executive and/or industry conferences

What we seek in this leader:

  • A mission-driven leader with a deep understanding of medical device clinical trial management who thrives in a collaborative, matrix, global organization and with a passion for patients and an unparalleled standard of excellence

  • Hand-on “roll up your sleeves” mindset with the ability to be a driver and change agent

Minimum Requirements:

  • Bachelor’s degree required, MBA or PhD degree preferred with experience exceeding that of a senior manager

  • Minimum of 15 years of medical device/pharmaceutical/biotech/CRO industry experience monitoring and managing clinical trials

  • Solid track record of people management experience with proven success in coaching, developing talent and creating strong teams in a results-driven culture

  • Must have Class III implantable medical device study management experience

  • Ability to travel 50%

Preferred Qualifications: In addition to meeting minimum requirements, it would be nice to have the following:

  • Experience working in a large medical device manufacturing company

  • Experience with management of cardiovascular devices is an advantage

  • Knowledge of Cardiovascular Physiology and structural heart anatomy is a strong preference

  • Prior clinical research experience with PMA, IDE, 510k is a strong preference

Additional Talents and General Expectations:

  • Proven successful project management skills

  • Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred

  • 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

  • Expert knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols while looking beyond existing methodologies and own discipline to define and resolve complex problems

  • Expert understanding of regulatory submissions, reporting, and audits

  • Knowledge of financial mechanism that relates to clinical trials

  • 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 trials to the business

  • Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions

  • 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 with senior management, and others concerning matters of significance to the company

  • Conduct business and technical briefings for senior and top management and for external representatives

  • Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization

  • 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 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.