Endologix, Inc

  • Director, Clinical Affairs

    Job ID
    2018-1843
    Location
    US-CA-Irvine
    Category
    Clinical
  • Overview

    Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

     

     

    Responsible for developing and conducting global clinical trials/studies on Endologix products and for ensuring compliance with global regulations governing conduct of clinical research and internationally recognized standards. Directs and manages the activities of Clinical Affairs department personnel, as well as external contractors (e.g., clinical research organizations (CROs), regional monitors, and consultants). This position requires a unique combination of leadership and execution abilities in order to accomplish the objective of generating quality clinical evidence to support the company’s products.

    Responsibilities

    To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    • Provides leadership, strategic planning, direction, and implementation of Clinical Affairs activities.
    • Establishes clear goals for the department that tie in to the broader company objectives, including managing to timelines and budget.
    • Has strong performance-based management skills to build organizational and scientific capabilities. Develops employees to stretch their skillsets, advance in their careers, and fosters exceptional teamwork across the organization.
    • Oversight for all phases of clinical research from premarket trials to post-approval studies, including both Endologix and physician sponsored. Studies can include projects of varying levels of clinical evidence from retrospective analyses to prospective, multicenter, randomized, controlled studies.
    • Partner with Regulatory Affairs, Clinical Marketing and Medical Affairs to provide clinical data to support regulatory submissions, publications, presentations, and sales/physician training programs.
    • Develop reputation in the industry for credibility, good clinical science by developing strong ties with physicians/thought leaders, regulatory agencies, professional societies, consultants, vendors, and co-workers.
    • Excellent writing skills to include preparation of clinical protocols, clinical study reports, statistical data analysis plans, monitoring plans, informed consent forms, case report forms, investigator agreements, financial disclosure agreements, clinical sections of regulatory submissions, and responses to regulatory agency’s questions.
    • Provides clinical input to product development teams, risk assessments, Health Hazard Evaluations (HHEs), and participates in physician/scientific advisory boards, Data Safety Monitoring Boards (DSMB), Clinical Events Committees (CEC), when appropriate.
    • Ensure compliance with all applicable regulatory standards related to clinical trials and interactions with physicians.
    • Foster a passion for the company’s purpose to revolutionize aortic care for life and maintain unwavering commitment to patient safety and clinical accuracy.
    • Creates a positive culture with a can-do attitude with strong work ethic.
    • Ability to travel 30% both domestic and international.

    Qualifications

    • Strong Leadership Ability
    • Excellent Communication Skills – communicates effectively in both written and interpersonal formats with all levels of the organization. Strong presentation and technical writing skills required.
    • Decision Making Skills – ability to exercise sound judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
    • Detail Oriented – unparalleled attention to detail and organization
    • Analytical Skills – ability to visualize, articulate, and solve both complex and uncomplicated problems and concepts and make sensible decisions based on available information
    • Consulting Skills – ability to work and partner effectively with others within the company and outside of the company.
    • Excellent Problem Solving Skills – ability to understand issues and communicate effectively with clients and team.

    Education:

     

    Bachelor’s degree in a clinical, scientific, or related field required. RN or BSN degree or equivalent.

    Advanced degree (Masters, PhD or MD) preferred.

     

    Experience:

     

    A minimum of 8+ years of Clinical Research experience in the Medical Device Industry to include multicenter IDE clinical trials, safety surveillance, and clinical team management. (Masters may substitute for one year of experience, PhD or MD may substitute for two years of experience).

    Experience in Cardiovascular, Vascular, and/or Class-III Devices is highly preferred.

    Strong working knowledge of medical/scientific terminology and knowledge of International and U.S. FDA (Food & Drug Administration) regulations and GCP guidelines is required.

     

     

    Supervisor Core Competencies:

    ·         Customer Focus: Solicit and apply feedback from internal and external customers; Understand customers’ current and future expectations; Respond promptly to customer needs.

    ·         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.

    ·         Organizational & People Development: Challenge and motivate people to reach their highest potential; Create an environment that encourages risk-taking; Set clear performance standards and hold people accountable for results; Value, recognize and reward the achievement of others; Promote teamwork; Encourage others to pursue challenging goals and to challenge the status quo; Foster continuous professional development and career growth of a diverse workforce; Provide challenging work assignments and development opportunities; Identify and champion high potential talent as a company resource; Coach and mentor future leaders; Require people to expand their capabilities, knowledge and skills; Function as both team player and leader; Provide frequent, informal feedback; Recognize the contributions of others; Continuously strive to increase and refine supervisory skills; Set and achieve challenging goals;

    ·         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.

    ·         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.

    ·         Decisions: 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.

    ·         Diversity: Respond with sensitivity to people of diverse perspectives, ideas, backgrounds, lifestyles and ages; Foster open communication and respect for the individual.

     

    Equipment Use & Abilities Required:

     

    ·         Equipment Use:   Copy machines, fax machines, calculators and personal computers and computer terminals.

    ·         Computer Skills: Software proficiency in Microsoft Office Suite.

    ·         Language Skills: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.   Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

    ·         Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

    ·         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

     

    WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

    The physical demands while performing the duties of this role require the employee to regularly sit, stand, and walk for extended periods of time. They must continuously use hands and/or legs for repetitive motion and simple grasping. Occasionally the employee will be required to lift or carry 20-50 lbs.

     

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

                                                

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed