Edwards Lifesciences Dir, Clinical Affairs THV in Irvine, California
The THV clinical organization is a multi-functional team supporting the product development lifecycle through groundbreaking clinical trial design and execution from first in man through post market surveillance, leading clinical evidence in THV worldwide.
As the Clinical Affairs Director for Global Indication Expansion & Sustaining Clinical Programs, you will provide leadership and clinical expertise in support of indication expansions for approved products.
This role is based in Irvine, California. Comprehensive relocation package is available.
Is the face of the Indication Expansion and Sustaining clinical research portfolio and can go deep on the technology and rationale for trial designs (both internally and externally).
Analyze, formulate, and present recommendations to advise and guide executive level leadership; develop and deliver executive level communication.
Responsible for the planning and execution of I/E and Sustaining research. Position will collaborate with cross-functional groups to ensure program success.
Ensures the on time execution of the I/E and sustaining trials globally and related activities are achieved per annual operating and scientific plan in collaboration with the Director of Strategy and Sr. Director of Global Trial Operations or designee and in accordance with global clinical processes, regulations and good clinical practices.
Ensures all safety surveillance and monitoring, identification and reporting of adverse events and device-related complications are submitted in accordance with regulatory and corporate/divisional requirements.
Collaborates with the Sr. Director of Clinical Operations to confirm that the management and maintenance of site and internal research documentation are handled in accordance with established Standard Operating Procedures (SOP´s) and regional research directives and guidelines for agency/internal auditing.
Maintains regular contact with cross-functional leaders (Finance, Marketing, Sales, R&D, etc.) for the exchange of study related information.
Flexible and forward thinking to modify research strategies as new evidence is discovered.
Management of clinical trial steering committees.
Direct clinical activities with overall responsibility of developing systems, planning, staffing, budgeting, managing expense priorities, recommending, and implementing changes to methods through manager(s) and/or experienced professionals.
Develop a robust talent development and succession planning in alignment with functional growth strategies across the clinical organization.
Oversee the proper management and training of all trial management, CRO staff and field clinical specialists working on Edwards’ research programs.
Mitigate/eliminate risk, direct and communicate highly complex projects, initiatives and/or strategies which includes negotiations with internal and external parties.
Provide strategic leadership and direction including the development and maintenance of significant KOL relationship.
Key stakeholder in Scientific Communication activities and verifies accuracy and relevancy: clinical data reports, presentations for Regulatory submissions, conferences, and study meetings (e.g., Executive Committees, DSMB, CEC, Steering Committees) and ensure accuracy and relevancy.
Experience managing cardiovascular clinical trials (i.e, coronary artery disease, peripheral vascular disease, congestive heart failure, etc.) from initiation to device marketing.
Bachelor's Degree in in scientific or related discipline with related experience including clinical strategy required.
Demonstrated successful track record in people management with ability to effectively lead and manage a diverse team across multiple geographies required.
Experience in managing clinical trial steering committees.
Clinical strategy and Project Management experience.
Advanced knowledge of international regulations of Good Clinical Practice (GCP), experience with Class III medical devices preferred, documented current continuing education in clinical research monitoring or experience in Clinical Research.
Experience in clinical, regulatory and marketing aspects of medical device technology.
Trial budget creation and management experience
Master’s, PhD, or other advanced degree
Experience working in a regulated industry.
Knowledge and/or experience in structural heart clinical research.
Experience with Class III medical devices.
Experience in clinical, regulatory, and marketing aspects of medical device technology
LEAN or Six Sigma training.
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.
Proven successful clinical trial and project management leadership skills with ability to meet deadlines on multiple projects, establish relationships and communications with sites and KOL’s.
Positive, team-oriented leader and collaborator with all internal and external stakeholders.
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Travel as required to professional conferences and meetings with investigators and clinical site personnel for relationship building purposes up to 30%.
Expert compliance with and 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.
Serves as core partner to senior leaders in Business Units, Functional Groups, and Regions.
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
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.