Director, Clinical Safety

3 weeks ago

Irvine, United States TalentBurst Full time
Position: Director, Clinical Safety, Req#: 8819-1

Location: Irvine, CA ( Remote)

Duration: 6+ Months Contract (Part-Time job, 20 hours per week)

More on this position :

What does your group do? We are responsible for generating, disseminating, and educating on the evidence for our innovation portfolio

Does your team use any specific technology/software you want us to look out for? Yes, standard industry tools and systems

What will a typical workday look like? Every day is different

What will the work schedule be? Can any overtime be expected? 20 hours per week for the year but varies week to week

Each day varies so its generally ad hoc and event-dependent. Certain meetings are pre-established (once per month etc)

Will there be any travel involved? Yes

Travel will depend on many factors: eg if internal, most will be Irvine...if external (eg conferences) will be where the conference is.

Will you consider remote work? If yes, will they need to be in a specific time zone? Yes

What are your top 3 required technical skills? Must haves? Preferred technical skills : Clinical skills as a CT surgeon, understanding of the ST surgery industry and space, understanding of the rules and stakeholders (government and customers)

Job Description:

Provide strategic, technical, and risk/benefit decisions on behalf of MACA and partnering with Marketing, Commercial, Quality, R&D, Regulatory Affairs and others as a physician expert and ambassador for projects needing qualified medical input and activities.

Education and Experience:
  • Doctor of Medicine in M.D. and board certification in Cardiothoracic Surgery or equivalent medical training, 10 years of previous clinical practice experience.
  • Experience in rules on Class II and III medical device technologies
Additional Skills :
  • Excellent communication skills and interpersonal relationship skills including negotiating and relationship management skills with the ability to drive the achievement of objectives
  • Recognized as an expert within MACA, supporting commercial, R&D, and Regulatory Affairs and broader organization with broad-based expertise across area and related functions
  • Expert understanding of clinical studies procedures while identifying applications of functional knowledge and existing methodologies to complex problems
  • Expert understanding of related aspects of processes and/or systems
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
  • Ability to interact with other medical professionals to help understand product issues and identify potential solutions with appropriate internal Edwards teams
  • Have established relationships in the clinical areas of focus for Heart Valve Therapies.
  • Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment
  • Adhere to all company rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control
Key Responsibilities:
  • Serve as an expert medical liaison between the SURG business and customers regarding our portfolio, their use in practice, and benefits as a physician expert to drive market development and adoption through evidence and education, support Client opportunity assessments, practice trends, advocacy and relevant strategic insights
  • Participate in medical risk/benefit evaluations and technical troubleshooting for Clinical Evidence Reports, safety evaluations, risk management and PMS reviews, and corrections/removals, as required.
  • Provide technical expertise to product development, professional education, design validation, RA, and Quality/RM including literature review and evaluation of evidence
  • Collaborate with new product development, professional education, MKT, and other functional activities providing his/her surgical insights to support innovation, go-to-market strategies, evidence and claims, to challenge the status quo
  • Help raise the organization's clinical acumen by providing expert guidance to Clinical Affairs, Regulatory Affairs, R&D, new product development, pre-clinical support and other teams to expand knowledge of patient disease treatments and physician expectations for product use.
  • Act as subject matter expert (or as a chairperson) in external and internal meetings and symposia by engaging stakeholders and teams where either general medical expertise is required or where specific (specialty training) medical input is required.
  • Other incidental duties
TB_HL

  • Medical Director, Device Safety Expert

    1 month ago

    Irvine, California, United States AbbVie Full time

    Job Title: Medical Director, Device SafetyThe Medical Director, Device Safety will play a critical role in ensuring the safety of our medical devices. This individual will be responsible for supporting the Product Safety Leads and potentially leading one or more products as the PST Lead under the direction of the Therapeutic Area Lead and Global TA Head.Key...

  • Medical Director, Device Safety Specialist

    1 week ago

    Irvine, California, United States AbbVie Full time

    Job DescriptionCompany DescriptionJob DescriptionThe Medical Director, Device Safety position plays a crucial role in ensuring the safety of pharmaceutical and biotechnology products. As a key member of the AbbVie team, this individual will be responsible for supporting the Product Safety Leads (PST) and potentially leading one or more products as the PST...

  • Medical Director, Device Safety

    5 months ago

    Irvine, United States AbbVie Full time

    Company DescriptionJob Description The Medical Director is responsible for supporting the Product Safety Leads (PST) and potentially support one or more products as the PST Lead under the direction of the Therapeutic Area (TA) Lead and Global TA Head in ensuring safety in one or more products to through surveillance, signal detection, validation and...

  • Clinical Safety Director-Part-Time

    2 weeks ago

    Irvine, CA, United States Ledgent Technology Full time

    Provide strategic, technical, and risk/benefit decisions on behalf of MACA and partnering with Marketing, Commercial, Quality, R&D, Regulatory Affairs and others as a physician expert and ambassador for projects needing qualified medical input and activities.Key Responsibilities:Serve as an expert medical liaison between the SURG business and customers...

  • Clinical Research Dietitian

    4 weeks ago

    Irvine, California, United States Irvine Clinical Research Full time

    Job SummaryIrvine Clinical Research is a leading independent clinical trial group on the West Coast, and we're expanding our research in GLP-1 analogs. As a Research Dietitian/Coordinator, you'll play a crucial role in these clinical trials, counseling study participants on lifestyle measures while coordinating clinical trials.Key ResponsibilitiesConduct...

  • Clinical Safety Specialist

    1 week ago

    Irvine, California, United States MSCCN Full time

    Foster collaboration and scientific curiosity to drive clinical practices and impact patient lives. As a Senior Specialist, Clinical Safety, you will oversee adverse events, develop training programs, and educate enrolling sites to ensure protocol requirements are followed.Key Responsibilities:Provide oversight on safety processes from site to CEC to ensure...

  • Director of Clinical Chemistry

    4 weeks ago

    Irvine, California, United States University Of California Irvine Full time

    Job SummaryWe are seeking an exceptional clinical chemist to lead our Clinical Chemistry Division as Director. The ideal candidate will have a strong background in clinical chemistry, excellent communication and managerial skills, and a commitment to education and research.Key ResponsibilitiesOversight of the Clinical Chemistry Division, including laboratory...

  • Clinical Development Director

    3 weeks ago

    Irvine, California, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly skilled Clinical Development Director - Neuroscience to join our team at BioSpace, Inc. This individual will be responsible for overseeing the direction, planning, execution, and interpretation of clinical trials or research activities of a clinical development program.Key ResponsibilitiesParticipate in cross-functional...

  • Senior Director of Clinical Pharmacology

    4 weeks ago

    Irvine, California, United States AbbVie Full time

    Job OverviewAbbVie is seeking a highly skilled Associate Director of Clinical Pharmacology to join our Translational Pharmacokinetics and Clinical Pharmacology group. As a key member of our team, you will provide project support and inform decision-making in both small molecule and biologics, novel drug delivery platform projects from Discovery to...

  • Senior Clinical Operations Director

    3 days ago

    Irvine, California, United States Lollipop Pediatric Dentistry & Orthodontics Full time

    We are seeking a skilled and experienced Clinical Manager to oversee the clinical operations at Lollipop Pediatric Dentistry & Orthodontics. As a key member of our team, you will be responsible for ensuring exceptional patient care, compliance with clinical protocols, and the efficient functioning of the dental team.Key Responsibilities:Clinical...

  • Clinical Instructor

    4 weeks ago

    Irvine, California, United States Stanbridge University Full time

    Stanbridge University is seeking a qualified faculty member to provide clinical instruction in the Fundamentals of Nursing Program. Reporting to the Program Director, the faculty member will be responsible for delivering clinical instruction according to an approved course syllabus using accepted and effective teaching methods. The ideal candidate will have...

  • Scientific Director, Clinical Development Eye Care Specialist

    4 weeks ago

    Irvine, California, United States AbbVie Full time

    Job SummaryAbbVie is seeking a highly skilled Scientific Director, Clinical Development Eye Care to lead the design, execution, and interpretation of clinical trials and research activities in the eye care therapeutic area. The successful candidate will utilize scientific methods to design and implement clinical protocols, and data collection systems to...

  • Scientific Director, Clinical Development Eye Care Specialist

    4 weeks ago

    Irvine, California, United States AbbVie Full time

    Job SummaryAbsorbent and innovative scientific director sought to spearhead clinical development in the eye care space. As a seasoned expert, you will leverage your profound understanding of complex clinical study principles to drive the development of groundbreaking treatments.ResponsibilitiesPrepare and present scientific reports and presentations using...

  • Clinical Laboratory Scientist, Microbiology Supervisor

    4 weeks ago

    Irvine, California, United States Shoreline Diagnostics Full time

    Job DescriptionShoreline Diagnostics is a leading clinical laboratory dedicated to providing innovative diagnostics to the Irvine and Orange County areas. We are seeking a highly skilled Clinical Laboratory Scientist to lead our Microbiology department.The successful candidate will be responsible for validating and creating procedures for the Microbiology...

  • Research Dietitian Specialist

    1 month ago

    Irvine, California, United States Irvine Clinical Research Full time

    Unlock the Future of Clinical ResearchIrvine Clinical Research is a leading independent clinical trial group on the West Coast, dedicated to advancing life-changing treatments. We're expanding our research in GLP-1 analogs, investigating the efficacy and safety of new investigational drugs in overweight and obese participants.As a Research...

  • Research Dietitian

    4 weeks ago

    Irvine, United States Irvine Clinical Research Full time

    Irvine Clinical Research is the largest independent clinical trial group on the West Coast. We're expanding our research in GLP-1 analogs, testing the efficacy and safety of new investigational drugs in overweight and obese participants. Can these agents help participants manage their weight, reduce cardiovascular events, or even help with conditions such as...

  • Environmental Health Safety Specialist

    6 days ago

    Irvine, United States Rangam Full time

    100% OnsiteEHS Specialist IIIRequired: safety and osha regulations knowledge and experience is required.Onsite 5 days a weekShould be able to work in field2-4 times a year on weekend will have to go onsite to check onsite safetyCreating or optimizing safety proceduresSolution oriented collaborative folksElectrical safetyRisk assessmentsBackground in...

  • Environmental Health Safety Specialist

    5 days ago

    Irvine, United States Rangam Full time

    100% OnsiteEHS Specialist IIIRequired: safety and osha regulations knowledge and experience is required.Onsite 5 days a weekShould be able to work in field2-4 times a year on weekend will have to go onsite to check onsite safetyCreating or optimizing safety proceduresSolution oriented collaborative folksElectrical safetyRisk assessmentsBackground in...

  • Marketing Director

    4 weeks ago

    Irvine, California, United States Hydration Room Full time

    Job DescriptionWe are seeking a seasoned Marketing Director to lead and manage all marketing initiatives for Hydration Room's clinics and services. This role will be responsible for driving growth, increasing brand awareness, and supporting the successful launch and expansion of new locations.Key Responsibilities:Lead and manage the marketing team, setting...

  • Marketing Director

    4 weeks ago

    Irvine, California, United States Hydration Room Full time

    Job Title: Director of MarketingWe are seeking a highly skilled and experienced Director of Marketing to lead our marketing initiatives and drive business growth for Hydration Room's clinics and services.Key Responsibilities:Develop and execute comprehensive marketing strategies to increase brand awareness and drive customer engagement.Lead and manage the...