Director Medical Affairs, Advance Technology
Company: Edwards Lifesciences Gruppe
Posted on: April 8, 2021
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account. Thank you for your patience. Director Medical Affairs,
Advance Technology USA - California - Irvine 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
- 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
- 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 Basic
- 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
- 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
- Proficient in Microsoft Office Suite and related tools and
systems. Strongly Preferred:
- 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
- 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. E dwards is an Equal Opportunity/Affirmative
Action employer including protected Veterans and individuals with
disabilities. Posted 3 Days Ago Full time Req-7036 About Us 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.
Keywords: Edwards Lifesciences Gruppe, Irvine , Director Medical Affairs, Advance Technology, Healthcare , Irvine, California
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