Director Clinical Scientist at Dexcom

, , United States -

Full Time

Start Date

Immediate

Expiry Date

23 Feb, 26

Salary

332600.0

Posted On

25 Nov, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Medical Devices, Regulatory Affairs, Data Analysis, Medical Writing, Team Leadership, Communication Skills, Statistical Analysis, Clinical Trials, Project Management, Endocrinology, Metabolic Disease, Scientific Evaluation, Clinical Evaluation, Interpersonal Skills, Programming Skills

Industry

Medical Equipment Manufacturing

Description

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: The Director of Clinical Science will lead the pre-commercial and key aspects of post-commercial Global Clinical Science team at Dexcom. As a Director of Clinical Science, you will leverage your scientific, medical device, and therapeutic expertise along with executive management skills to drive the global pre-commercial clinical strategy. Your team will lead the development, design, analysis and reporting of Dexcom's clinical studies to meet the labeling, claims, and global regulatory needs of the business. Your team will be responsible for interactions with regulatory agencies as needed and will use your scientific, engineering and medical knowledge to provide directives to teams and study sites as needed. Where you come in: Provide leadership and long-term vision to the Global Clinical Science team to meet the business objectives. Provide input on best practices in clinical research to develop CGM products in a regulated environment inclusive of gold standard endpoints and outcome measures, scientific/ clinical evaluations, study instruments, questionnaires, and relevant standards for evaluating medical devices Informs clinical evaluation (plans and reports), clinical trial protocols, protocol amendments, and scientific publications. Facilitates communication between Commercial, Marketing, R&D, Clinical Program Management, Regulatory & Scientific Affairs, Medical Writing, Product Development, Quality Assurance/Compliance, Medical Affairs, and external CROs. Conduct team meetings and present regular updates to senior staff. Participates in clinical study or clinical evaluation timelines, and budgets Examine data sets and determine the best end-to-end analysis plan to address key scientific questions Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature and staying abreast of current clinical practice. What makes you successful: You will have a PhD, MD, and/or equivalent in endocrinology, metabolic disease or related field with extensive clinical research experience in medical devices. Excellent communication and interpersonal skills. Ability to simplify complex concepts and communicate these to non-clinical team members Expertise in medical writing, including authoring and leading clinical evidence reports, clinical study reports, and other reports needed for regulatory filings and meetings, in the US and globally Optional but nice to have: Advanced Programming Skills (Python, R, SPSS, SAS, MatLab, Etc) and demonstrated advanced statistical analysis experience Experience in the European market Ability to work in a matrixed organization What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: 15+ years of industry experienceTypically requires a Bachelor's degree with 9+ years of successful management experience in relevant industry Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at talentacquisition@dexcom.com. 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 Dexcom Talent Acquisition at talentacquisition@dexcom.com. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: https://health1.meritain.com/app/public/#/one/insurerCode=MERITAIN_I&brandCode=MERITAINOVER/machine-readable-transparency-in-coverage?reportingEntityType=TPA_19874&lock=true 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. Salary: $199,600.00 - $332,600.00

Responsibilities

The Director of Clinical Science will lead the Global Clinical Science team, driving the pre-commercial clinical strategy and overseeing the development and reporting of clinical studies. This role involves facilitating communication across various departments and ensuring compliance with regulatory requirements.