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.
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.
Bachelor’s degree in a clinical, scientific, or related field required. RN or BSN degree or equivalent.
Advanced degree (Masters, PhD or MD) preferred.
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