Endologix, Inc

  • Senior Aortic Therapy Manager

    Job ID
    2018-1939
    Location
    US-CA-Irvine
    Category
    Medical Affairs
  • Overview

    A core member of the Global Medical Affairs (GMA) team, the Senior Aortic Therapy Manager participates in defining and disseminating best practices in clinical care to ensure optimal patient outcomes. Individual possesses superior clinical knowledge and acumen of aortic therapy including Endologix's product portfolio and respective clinical application; Functions as one of the organization’s aortic therapy experts. The Sr. Aortic Therapy Manager is responsible for procedure development and liaises with clinicians to validate procedure standardization guidance. Position commands a high level of cross functional alignment, close collaboration with, and accountability to Endologix strategic plans and business objectives, all while maintaining a high level of clinical integrity with a “patient first” paradigm. A senior member of the GMA team, the Sr. Aortic Therapy Manager serves jointly as an individual contributor and team leader.

    Responsibilities

    • Procedure Development: Provides input into the development and validation of the clinical application of the Endologix product portfolio, clinical application, indications, contraindications, warning and precautions, implant techniques, procedural best practices, and procedural troubleshooting.
    • Product and Procedure Training: Provides subject matter expert support to Medical Education; collaborate ---provide input into / serve as a consultant for the development and execution of training curriculum; produce product information, guidelines, clinical best practices, and other tools for incorporation into training programs; serve as faculty for physician and field sales product training programs; Assess and certify field-based clinical specialists, aortic account managers, and distributors with the objective of independent case support and case planning; Participate in new product launches via providing input into the development of internal and customer-facing training strategies and plans, content development and via delivery of product in-servicing, training and certification to both internal and external audiences.  
    • Thought Leader Relationships: Develop and maintain positive and collaborative working relationships with experts and thought leaders in the endovascular community; Consult and liaise with physician leaders as appropriate in the development and execution of programs for which medical affairs is responsible; Create opportunities to pursue potential new collaborations with key opinion leaders.
    • Clinical Trial Support: Support Endologix clinical trials, including participation in the development of training plans and respective content; Conduct proctor, investigator, hospital clinical staff, and clinical specialist product and procedure training and credentialing; Serve as a Trainer for other trainers in this role (Train-the-trainer). Attend and lead clinical trial cases; Participate in clinical trial case review boards; adverse event review, site support and troubleshooting, and case management of endovascular secondary interventions when indicated.
    • Complex Case Consultation: Respond to immediate field needs for complex case consultation and off-label planning in accordance with company policies; Activities range from responding to imaging review, providing recommendations for case planning, and coordination of qualified case coverage when indicated.
    • Imaging Services: Consult with certified sales team members to provide preoperative case planning and sizing of product; Manage and analyze other forms of imaging datasets if required and offer product recommendations; Interpret CT scans and 3D reconstruction; Develop device planning recommendations to physicians and sales team members by analyzing CT datasets
    • Field Assurance Support: Respond to adverse events by analysis, remediation and training; Participate in field assurance review and investigation of product complaints, complaint trends, and associated CAPAs; Upon request, participate in data collection and root cause analyses; Provide recommendations for improving product performance, clinical best practices and respective training; monitor and measure results.
    • Regulatory Support: Provides expert support to the regulatory team for IFU development and regulatory submissions.
    • Compassionate Use: Assess and triage compassionate use requests for clinical suitability; Provide recommendations for case planning; Determine and assign appropriate case coverage.
    • Maintain strict adherence to all Company procedures and policies pertaining to product complaint and Adverse Event reporting, training documentation policies and procedures, and other relevant corporate procedures/polices.

    Qualifications

    • Minimum BS/BA degree, preferably in an allied health, engineering or scientific discipline, or equivalent combination of education and experience.
    • 9+ years of vascular interventional experience
    • 5+ years of industry clinical support and instructional experience
    • Candidate should have at least seven (7) years of relevant clinical or product development experience
    • Particular value will be assigned to those candidates who are able to demonstrate a clinical knowledge of endovascular aneurysm repair

    Core Competencies:

    • Accountability: Expect consistently high performance from myself and others
    • Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.
    • Intra-department Partnership: Foster a culture of “one Endologix”; Commit to unite all Endologix sites and all functions; Align actions; Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.
    • Operational Excellence: Prioritize and act with integrity and urgency to ensure quality and compliance.
    • Commitment: Strive to attain quality results on time; Convey a sense of urgency and drive issues to closure; Earn a reputation for reliability and dependability.
    • Decision Making: Make timely and sound decisions; Take risks and manage them intelligently;
    • Problem Solving: Proactively seek solutions; Gather and analyze information systematically; Develop alternative solutions; Think analytically and act decisively.
    • Reasoning Ability: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form
    • Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.
    • Innovation: Develop and champion unique ideas and solutions; Find new ways to use technology more effectively; Promote continuous learning.
    • Interdependent Partnering: Contribute to a productive and cooperative atmosphere; Show commitment to team objectives; Contribute own fair share of effort.
    • Master Complexity: Competently handle day-to-day work challenges; Thrive in uncertain circumstances; Adapt to changes in the work environment; manage multiple tasks and competing demands; Change approach or method to best fit the situation; operate with a sense of urgency when needed to meet critical timelines.
    • Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company
    • Presentation Skills: Strong presentation background. Able to presenting technical, extremely important and sometimes sensitive information. 
    • Spoken Communication: Speak clearly and concisely; listen carefully and seek clarification; Deliver effective presentations.
    • Written Communication: Write clearly and informatively; Create documents that are complete and accurate.

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