Edwards Lifesciences Director Medical Affairs, Advance Technology in Irvine, California
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.
The Advanced Technology group at Edwards incubates and explores world-class innovations for under-served patients with Structural Heart Disease. This Director, Medical Affairs role will anchor the medical affairs activity for the Advanced Technology group working closely with the clinical affairs team and the strategy team. The role will support the current activities such as clinical trial design and clinical strategy for current and future technologies within the Advanced Technology group. In addition, the role will partner with the strategy team on future "where to play" and “how to win” decisions for novel disease areas, patient populations, and product modalities.
This is a great opportunity to work in a small team to guide the next wave of innovation at Edwards and shape the global landscape of Structural Heart Disease. This highly collaborative role will partner with multiple teams that compete on numerous projects based on value proposition and feasibility of new products. This strategic role will provide clinical and technical guidance and drive new and evolving innovation portfolio for the future of the organization.
Your Key responsibilities:
Work with the clinical and regulatory team to develop clinical protocols for early feasibility and pivotal studies of new technologies.
Serve in an advisory role to management to provide direction and guidance to teams to execute enterprise-level projects, initiatives and/or programs
Create a presence at key scientific conferences and build relationships with key KOL advisors.
Serve as a resource on clinical evidence for the Advanced Technology group
Conduct initial high-level business fit and scientific and clinical evaluation of potential opportunities to determine if they are worthy of further, detailed functional evaluation
M.D., high level clinical training, or Ph.D.
12 years of previous experience including clinical experience, clinical trials, academia and/or industry experience required.
Expert understanding of business strategy, competitive landscape, regulatory environment, and clinical data while looking beyond existing methodologies and own discipline to define and resolve complex problems
Experience working in a clinical setting, pharmaceutical or medical device industry is required.
Expert understanding of cardiovascular diseases and therapies
Extensive understanding of biostatistics.
Proven track record in developing and maintaining relationships with internal and external stakeholders
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
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
Proficient in Microsoft Office Suite and related tools and systems.
Structural Heart knowledge and experience
Creative and strategic, abstract problem solver with high curiosity quotient including possessing rigorous analytical disciplined and ‘hypothesis’ driven approach using a combination of top-down and bottom-up analyses.
Ability to operate fluidly between strategic/conceptual and tactical/executional.
Ability to influence others and ability to partner/collaborate with cross functional teams.
Ability to quickly evaluate solution viability, courage to fail fast and learn from mistakes.
Strong interpersonal skills as team leader and team player with experience cross-functional team management.
Excellent communication and presentation skills; dynamic (persuasive) in presenting ideas to teams.
Recognized as an expert within sub-function(s) and/or area(s) and broader organization with broad-based expertise across area and related functions.
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.