Edwards Lifesciences Senior Manager, Medical Affairs in Irvine, California
The primary work location for this role is in Irvine, CA, and may be remote
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring with a rapidly growing portfolio of innovative/less invasive solutions.
To identify and demonstrate the patient’s benefit from these new therapies and innovative solutions, the company is seeking an experienced Senior Manager, Medical Affairs professional. This Senior Manager will work closely with internal stakeholders and external thought leaders/partners to drive projects and help develop and implement the medical affairs strategy regarding the burden of structural heart disease and improved patient care.
Develop and enhance working relationships with key professional organizations and serve as company lead on high profile burden of disease projects
Provide input into the development of a Key opinion leader (KOL) engagement plan and maintain strong relationships with KOLs to expand on our understanding of treatment and referral patterns in the relevant disease state and future standards of care
Lead KOL scientific advisory board planning and execution to understand their evolving medical needs and identify knowledge gaps & opportunities for collaboration and scientific exchange
Identify gaps in evidence & patient care proactively for input into Medical Affairs strategy, and outline tangible initiatives to drive action against these gaps
Collaborate closely with internal stakeholders including other medical affairs functions, health economics and outcomes research, data analytics, patient education, marketing, corporate strategy and government affairs to drive cross-functional alignment and provide leadership on key disease state projects and initiatives
Provide input into the development of an effective medical communications plan
Develop disease state awareness educational materials for dissemination to internal and external stakeholders and provide support for CME program planning
Provide expert input into investigator sponsored trial/studies and maintain communication with the investigators during the study
Provide support for each business unit’s scientific abstracts, manuscripts, investigator-initiated study protocols, patient advocacy grant requests, and scientific educational grant requests as needed
Attend key meetings and congresses, monitor published literature, and provide competitive intelligence insights on disease state and products
Collaborate with legal, compliance, regulatory, and key cross-functional business partners, performing all responsibilities in compliance with regulatory and legal requirements as well as industry guidelines
Ability to travel up to 20% (post-COVID); and the individual may work remotely, but also must be able to travel to the Irvine office as required/needed
PhD/MD/PharmD degree with 8 years of experience working within clinical, research, and healthcare industries; or Master’s degree with 10 years of experience; or Bachelor’s degree with 12 years of experience
Experience leading projects and cross-functional project teams within a matrix organization
Additional Skills & Preferred Qualifications :
An advanced degree (MD, PhD, PharmD) is preferred
5+ years of broad Medical Affairs, Clinical Affairs, Clinical Research, or Clinical Marketing experience within the pharmaceutical and/or medical device industry preferred
Therapeutic knowledge and experience in cardiology or cardiometabolic diseases
Demonstrated ability cultivating and maintaining strong relationships with industry leaders / KOLs / professional societies
Experience with real-world evidence generation and research collaborations
Experience with developing disease state materials and educational programs
Medical communications and publication evidence management experience.
Experience working with providers, payers, and patient advocacy groups
Independent thinker, able to manage & drive own projects over a multi-year timeframe
Able to critically assess scientific literature & engage in scientific dialogue
Strategic thinker, able to identify opportunities for Medical Affairs to progress Edwards priorities
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.