Director, Medical Affairs/Clinical Science (Remote, US) Transcatheter Mitral and Tricuspid TherapiesEdwards 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 and less invasive solutions. To design new transcatheter, mitral, and tricuspid therapies from the ground up, the company is seeking an exceptional Medical Affairs professional with significant clinical experience to join their team. The Transcatheter, Mitral and Tricuspid Therapies (TMTT) division is dedicated to developing solutions to the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives. TMTT is developing world-class clinical evidence through their portfolio of products, 5 of which are in the early feasibility stage, 4 undergoing pivotal trials, and 3 in post market follow-up phase in Europe. We are seeking talented and passionate professionals to join this fast-paced, dynamic team and play a pivotal role in the development of new therapies and devices, from concept through to human use.A new role within the company, the Director, Medical Affairs will report to the Senior Director, Medical Affairs. This individual will be the subject matter expert on trial design and structural heart (mitral and tricuspid) therapies. As a key member of the Medical Affairs, Clinical Science & Biometrics team, this individual will provide scientific expertise in the development of clinical trial strategy and clinical study design, provide input to clinical evaluation reports, clinical study protocols, risk management, and /or clinical studies in alignment with the TMTT business strategy. Through extensive interaction with clinician thought leaders (KOLs) along with a strong diverse cross-functional leadership team within the organization, this individual will have opportunities to make strategic and scientific impact on our current and future clinical portfolio. This position is suited for a clinician with an interventional cardiology or heart failure specialist background along with a strong background of trial design. It will give individuals the chance to shape mitral and tricuspid therapies that will ultimately transform treatment. This role offers a dynamic, challenging, and rewarding environment with the potential for growth and professional advancement for the right candidate.The Director will be either a clinician with interventional cardiology background or seasoned medical device professional with strong trial design experience, clinical strategy, clinical and scientific acumen and a commitment to putting patients first.Key ResponsibilitiesResponsible for alignment with trial leaders - Biometrics, Regulatory Affairs, Global Healthcare Economics and Reimbursement (GHER), Marketing, Strategy and QualityWork closely with R&D, marketing, clinical and executive management to identify clinical evidence study opportunities and prioritiesProvide advice with respect to regulatory strategy; Collaborate with internal regulatory experts to ensure compliance with schedules for PMAs/IDEs, EU and JAPAC submissionsWork with biometrics, safety and other cross-functional team members in the review and interpretation of dataPartner with GHER for study design to support reimbursement in major marketsGuide the development of the clinical study protocol/protocol amendments, periodic update of CERs and CER-related documentsSubject matter expert for guidelines and regulations regarding the clinical evaluation processProvide review and input to clinical and scientific aspects of regulatory filings, including technical summaries, labeling statements, IFU, Claims Matrix, Annual Progress Reports, and Clinical Evaluation ReportsDevelop an effective working relationship with multiple internal stakeholders including Clinical Affairs, Regulatory Affairs, Program Management, Research and Development, Quality and MarketingDevelop a strong working relationship with various healthcare professionals including KOLsCollaborate and partner with Legal and Compliance as well as other key cross functional business partnersPerform all responsibilities in full compliance with regulatory requirements, legal requirements, and industry guidelinesSupervisory Responsibilities: provides scientific leadership and mentoringMinimum RequirementsMD with Interventional cardiology, Interventional imaging or Heart Failure experience ORPharmD, DVM or PhD in scientific field with at least 10 years of related work experience leading the Medical or Clinical Affairs function within the medical device industry ORMasters degree in scientific field with 14 years of experience as listed above ORBachelor’s degree in scientific field with 16 years of related work experience as listed aboveIndustry collaboration working on trial design expected for MDsExtensive knowledge and hands on experience supporting clinical sciences in Structural heart including clinical trial design, protocol development, endpoint selection and biostatisticsAbility to travel up to 20% globally for conferences as neededPreferred Qualifications: In addition to meeting minimum requirements, it would be nice to have the following:Experience leading a medical or clinical affairs function supporting cardiac devices within the medical device industryPrior experience working on trial design, PMAs and global (NMPA, PMDA, etc.) regulatory submissionsStrong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulationsFor Colorado Residents Only:Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.The base pay range for this position is $ to $ Additional information can be found through the link below:Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
Edwards Lifesciences
Mississippi
United States
Healthcare - Allied Health
(No Timezone Provided)
Director, Medical Affairs/Clinical Science (Remote, US) Transcatheter Mitral and Tricuspid TherapiesEdwards 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 and less invasive solutions. To design new transcatheter, mitral, and tricuspid therapies from the ground up, the company is seeking an exceptional Medical Affairs professional with significant clinical experience to join their team. The Transcatheter, Mitral and Tricuspid Therapies (TMTT) division is dedicated to developing solutions to the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives. TMTT is developing world-class clinical evidence through their portfolio of products, 5 of which are in the early feasibility stage, 4 undergoing pivotal trials, and 3 in post market follow-up phase in Europe. We are seeking talented and passionate professionals to join this fast-paced, dynamic team and play a pivotal role in the development of new therapies and devices, from concept through to human use.A new role within the company, the Director, Medical Affairs will report to the Senior Director, Medical Affairs. This individual will be the subject matter expert on trial design and structural heart (mitral and tricuspid) therapies. As a key member of the Medical Affairs, Clinical Science & Biometrics team, this individual will provide scientific expertise in the development of clinical trial strategy and clinical study design, provide input to clinical evaluation reports, clinical study protocols, risk management, and /or clinical studies in alignment with the TMTT business strategy. Through extensive interaction with clinician thought leaders (KOLs) along with a strong diverse cross-functional leadership team within the organization, this individual will have opportunities to make strategic and scientific impact on our current and future clinical portfolio. This position is suited for a clinician with an interventional cardiology or heart failure specialist background along with a strong background of trial design. It will give individuals the chance to shape mitral and tricuspid therapies that will ultimately transform treatment. This role offers a dynamic, challenging, and rewarding environment with the potential for growth and professional advancement for the right candidate.The Director will be either a clinician with interventional cardiology background or seasoned medical device professional with strong trial design experience, clinical strategy, clinical and scientific acumen and a commitment to putting patients first.Key ResponsibilitiesResponsible for alignment with trial leaders - Biometrics, Regulatory Affairs, Global Healthcare Economics and Reimbursement (GHER), Marketing, Strategy and QualityWork closely with R&D, marketing, clinical and executive management to identify clinical evidence study opportunities and prioritiesProvide advice with respect to regulatory strategy; Collaborate with internal regulatory experts to ensure compliance with schedules for PMAs/IDEs, EU and JAPAC submissionsWork with biometrics, safety and other cross-functional team members in the review and interpretation of dataPartner with GHER for study design to support reimbursement in major marketsGuide the development of the clinical study protocol/protocol amendments, periodic update of CERs and CER-related documentsSubject matter expert for guidelines and regulations regarding the clinical evaluation processProvide review and input to clinical and scientific aspects of regulatory filings, including technical summaries, labeling statements, IFU, Claims Matrix, Annual Progress Reports, and Clinical Evaluation ReportsDevelop an effective working relationship with multiple internal stakeholders including Clinical Affairs, Regulatory Affairs, Program Management, Research and Development, Quality and MarketingDevelop a strong working relationship with various healthcare professionals including KOLsCollaborate and partner with Legal and Compliance as well as other key cross functional business partnersPerform all responsibilities in full compliance with regulatory requirements, legal requirements, and industry guidelinesSupervisory Responsibilities: provides scientific leadership and mentoringMinimum RequirementsMD with Interventional cardiology, Interventional imaging or Heart Failure experience ORPharmD, DVM or PhD in scientific field with at least 10 years of related work experience leading the Medical or Clinical Affairs function within the medical device industry ORMasters degree in scientific field with 14 years of experience as listed above ORBachelor’s degree in scientific field with 16 years of related work experience as listed aboveIndustry collaboration working on trial design expected for MDsExtensive knowledge and hands on experience supporting clinical sciences in Structural heart including clinical trial design, protocol development, endpoint selection and biostatisticsAbility to travel up to 20% globally for conferences as neededPreferred Qualifications: In addition to meeting minimum requirements, it would be nice to have the following:Experience leading a medical or clinical affairs function supporting cardiac devices within the medical device industryPrior experience working on trial design, PMAs and global (NMPA, PMDA, etc.) regulatory submissionsStrong knowledge of scientific research methodology, device development process, GCP, ICH guidelines and Global (US FDA, EU MDR) regulationsFor Colorado Residents Only:Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.The base pay range for this position is $ to $ Additional information can be found through the link below:Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.