Edwards Lifesciences Director, Clinical Research, International Programs - THV (Remote) in Irvine, California
Director, Clinical Research, International Programs- THV
Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease.
This is an exciting opportunity within a company that leads the heart valve market, not only in terms of market share but also in cutting edge technology. The Transcatheter Heart Valve (THV) team extends Edwards’s leadership into the transcatheter area, providing immediate new treatment alternatives to patients with no or few other alternatives, eventually positioning THV as the treatment of choice for aortic stenosis.
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.
Manage clinical project managers and their projects internationally as required.
Provide leadership and clinical expertise in support of new product development and/or marketed products.
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
Analyze, formulate and present recommendations to advise and guide executive level leadership; develop and deliver executive level communication
Mitigate/eliminate risk, direct and communicate highly complex projects, initiatives and/or strategies 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. 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.
Bachelor's Degree required
A minimum of 10 years clinical strategy experience required
Demonstrated track record in people management with ability to effectively lead and manage a diverse team across multiple geographies
Experience with Class II & III medical devices required
Strong EU and international experience
Master’s, PhD, or other advanced degree
Relevant clinical trial experience in heart valve disease, coronary artery disease, peripheral vascular disease and congestive heart failure areas strongly preferred
Experience in managing clinical trial steering committees
Experience in clinical, regulatory and marketing aspects of medical device technology
Lean Six Sigma
Proven successful project management leadership skills with ability to meet deadlines on multiple projects
Excellent facilitation and presentation skills
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
Ability to establish relationships and manage communications with key clinical customers (e.g., physicians, nurses, administrators)
Expert 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
Excellent financial and business acumen
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 affairs to the business
Knowledge of biostatistical and actuarial methods
Fully comply with all US and Global regulations, and SOPs in the execution of all job duties
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
Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions
Approximately 50% Domestic and International Travel
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.