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Senior Director Clinical Affairs

Company: Dexcom Inc.
Location: San Diego
Posted on: February 22, 2021

Job Description:

Dexcom, Inc. empowers people to take control of diabetes through innovative-- continuous glucose monitoring (CGM) -- systems. Headquartered in San Diego, California, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. Summary:
The Senior Director, Clinical Affairs will lead our clinical research activities in the design and execution of clinical trials to support approval and commercialization of Dexcom's medical devices. Reporting directly to the Vice President, Clinical Affairs, the role will be responsible for overseeing the Clinical Team in the develop of clinical strategies and the planning, conducting, and monitoring of multiple clinical trials within the US and globally of varying size and complexity. Clinical trials and analysis will include those designed to support regulatory submissions, reimbursement, CGM category and Dexcom share of category growth. The role will work in close collaboration with R&D, Regulatory, Marketing, Quality, Data Management and Biostatistics.
-- Essential Duties and Responsibilities:

  • Leads the Clinical Team of in-house and field-based Clinical Research Associates in the execution of clinical studies
  • Ensures the logistical details, study protocols, enrollment, training needs, milestones, clinical study reports, budgets and timelines are met for all studies
  • Develops and execute clinical strategies, as well as identifies and implements best practices to increase effectiveness and efficiency of the organization and execution of clinical studies
  • Ensures that Dexcom sponsored clinical trials and studies are executed in accordance with Food and Drug Administration (FDA) regulations, Institutional Review Board (IRB) approval, and Good Clinical Practices (GCPs)--
  • Builds strong relationships with clinical site staff (PI's-MD's), investigators, other medical professionals, and Contract Research Organizations (CROs) to ensure proper prioritization and execution of our clinical trials and studies
  • Builds relationships and collaborates with key opinion leaders to help develop strategies and priorities for the clinical organization
  • Designs and directs clinical studies to include building patient and physician education and product materials
  • Collaborates and influences R&D, Quality, Regulatory and other leaders around product improvements, technologies, intellectual properties and other clinical issues
  • Collaborates with Marketing and New Markets to develop and identify studies to support commercial operations
  • Partners with Data Management and Biostatistics leadership to ensure that clinical studies are properly planned, performed and analyzed
  • Develops resource management strategies to support clinical studies to include ensuring the right number of resources and budget allocation
  • Ensures that budgets, on-time completion of clinical milestones, and performance requirements are met
  • Plans and assists with the preparation of regulatory submissions (e.g., IDEs, PMAs, and PMA supplements).
  • Organizes project and departmental objectives and delegate tasks effectively--
  • Implements legal requirements of contracts, non-disclosure agreements, and financial agreements in clinical programs--
  • Ensure forms and other site regulatory documents are complete and accuracy, while ensuring compliance with FDA, Health Canada, EU, other International requirements and Good Clinical Practices guidelines.
  • Create study-specific manuals, guidelines, and forms to effectively implement protocols and provide input for the development of protocols.
  • This position assumes and performs other duties as assigned. Required Qualifications:
    • Results-oriented, self-disciplined, fast-paced, motivated individual that requires minimal supervision and able to multitask several projects at one time.
    • Proven track record of successfully designing, planning and executing medium to large scale clinical studies, to include creative study design, resource planning and budgeting, contingency planning and timely execution--
    • Ability to deal with ambiguity - ready and able to effectively and efficiently change plans quickly to meet the changing needs of the business and projects--
    • Highly collaborative and desire to reach across the organization to understand needs and how to meet those needs.
    • Proven ability solving complex problems, with the ability to get to true problem that needs to be solved and foresee problems and proactively mitigate before they happen
    • Ability to ruthlessly priorities own active and teams to ensure spending time on the critical few priorities that are most important to the organization
    • Proven ability to effectively influence both internal and external groups in a direct and diplomatic way while able to hold ground without damaging relationships and minimizing noise--
    • Track record of recruiting exceptional talent, building high performing teams to include managing, mentoring and motivating employees
    • Strong Communication (oral/written) to included strong presentation skills, including ability to communicate in small and large settings and with senior level management, regulatory agencies and physicians
    • Strong analytical and business skills; with the ability to communicate effectively at all levels within the organization and clinical sites
    • Demonstrated ability to process complex information and summarize it concisely in writing and/or verbally in a professional manner
    • In depth understanding of healthcare, device, and biotechnology industry issues
    • Highly collaborative and desire to reach across the organization to understand needs and how to meet those needs.
    • Computer skills: Microsoft Office Suite - Word, Excel and PowerPoint, Adobe Acrobat Pro Preferred Qualifications:
      • Experience training to both medical device product and clinical protocol execution.
      • Knowledge of clinical methodology and application in clinical protocol development. Experience and Education Requirements:
        • Typically requires a Bachelor's degree (preferably in life sciences, biomedical engineering, biostatistics, health care or similar field)--
        • Advanced degree preferred (e.g., Masters, PhD, MD, etc).
        • 17+ years of industry experience. 13+ years of years of successful leadership experience in relevant industry.
        • Minimum of 5 years of people management experience. Travel Required:--
          • Up to 30% Functional Description: Management Oversees the direction, planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of confidentiality agreements and clinical agreements. Monitors adherence to protocols and determines study completion. Manages clinical and regulatory files and maintains clinical inventory intended for distribution to investigational sites. May interact with investigational sites, clinical consultants, Contract Research Organizations and other vendors. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Functional/Business Knowledge:
            • Possesses in-depth knowledge of the leading practices of a functional area and familiarity with several others.
            • Fully understands and translates organization, business strategies, and company's goals to functional priorities. Scope:
              • Makes final decisions on administrative or operational matters and ensures effective achievement of objectives.
              • Interacts internally and externally with others, requiring negotiation of extremely critical matters.
              • Recognized as an influential leader throughout the organization. Judgement:
                • Consistently works with abstract ideas or situations across functional areas of the business.
                • Thorough assessment of factors, identifies and evaluates fundamental issues, providing strategy and direction.
                • Erroneous decisions will have a long-term effect on the company's success. Management:
                  • Effectively able to operate in complex or matrix environment.
                  • Directs and controls the activities of one or more functional areas, divisions, product groups or service areas through senior managers who have overall responsibility for the successful operation of those assigned areas. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition .-- To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized--staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions.--Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team,--Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Get Matched Upload Your Resume To See How Well You Match To This Job. Match Unknown Other Similar Jobs Director, New Markets Clinical Strategy Clinical Affairs Senior Regulatory Affairs Specialist, International Regulatory Affairs Senior Regulatory Affairs Specialist, International Regulatory Affairs Intern - Regulatory Affairs Internship Clinical Research Associate 3 - Clinical Studies Clinical Affairs Sr Clinical Research Associate Clinical Affairs Clinical Research Associate 2 Clinical Affairs Sr. Regulatory Affairs Specialist, CER Regulatory Affairs Clinical Research Associate Clinical Affairs Recommended Videos for you Dexcom - Learn More About Us - YouTube Working at Dexcom - Dexcom Careers - YouTube What does it mean to be a Dexcom Warrior? - YouTube Why Apple And Google Are Working On Diabetes Tech - YouTube Warrior Mashup video - YouTube Dexcom Warrior & Olympic Skier Kris Freeman Shares his Personal Diabetes Story - YouTube Health, Life, Vision, and Dental Insurance Flexible Spending Accounts 401(k) program Employee Stock Purchase Program (ESPP) Telehealth and Employee Assistance Programs Our Philosophy Dexcom empowers people to take control of diabetes. We focus on enabling better outcomes for patients, caregivers and clinicians by delivering solutions that are best in class-defined as being dependable, simple and essential to taking control of diabetes. We are committed to revolutionizing diabetes care by seeking out and solving the needs of our employees, collaborators and community. Listen Comprehend the needs of people affected by diabetes. Serve with integrity Act in the best interest of our community. Think big Use technology to revolutionize diabetes care. Inspire confidence within our community and in one another. Jordan Morris The Dexcom Continuous glucose monitoring (CGM) System helps Jordan eliminate surprise highs or lows when he's about to go out on the field.

Keywords: Dexcom Inc., San Diego , Senior Director Clinical Affairs, Healthcare , San Diego, California

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