Edwards Lifesciences Director, Clinical Affairs (Global Clinical Strategy & Operations) in Irvine, California
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 Global Clinical Strategy and Operations Director, you will manage a clinical team and oversee the development of all clinical documentation for regulatory submission, develop clinical trial design, oversee planning and execution of clinical trials, and monitor competitive research to inform cross-functional teams.
Develop complex clinical trial design and strategies with consideration for risk mitigation and business needs/expectations, for input into protocol creation; includes negotiations with internal and external parties.
Direct Clinical team and activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending, and implementing changes to methods through several SMEs and/or managers.
Plan and direct strategic activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives. Lead in identifying risk, developing complex mitigation strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional and/or matrix teams including but not limited to:
Ensure on time execution of clinical trials in accordance with global clinical processes, regulations, and good clinical practices.
Effectively partner with internal team members to drive clinical trial success across multiple functions
Provide strategic leadership and direction including the development and maintenance of significant KOL relationships.
Key stakeholder in 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 talent development and succession planning in alignment with functional growth strategies. Provide input, guidance, and review of documents for regulatory submissions.
Serve in an advisory role to clinical management to provide strategic direction and guidance on programs. Serve as the core team member representing Clinical Affairs function on multiple PDP core teams.
Monitor competitive clinical research and landscapes and communicate key strategies and changes to cross-functional leadership.
Bachelor's Degree required
Previous related experience in clinical project leadership across multiple studies/programs.
Proven track record in successful trial design and execution.
Experience in cardiovascular and structural heart devices and therapies required
- Bachelor's Degree in Nursing, Physician Assistant, Doctor of Medicine Preferred.
Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Expert understanding of related procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems.
Expert understanding of related aspects of processes and/or systems.
Expert knowledge of financial mechanism that relates to Medical Affairs.
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.
Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions.
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.
Ability to travel up to 30%
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.