Sr Staff Clinical Scientist at Dexcom

, , United States -

Full Time

Start Date

Immediate

Expiry Date

16 Mar, 26

Salary

260600.0

Posted On

16 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Strategy, Medical Device Regulations, Clinical Research, Data Analysis, Medical Writing, Regulatory Submissions, Cross-Functional Collaboration, Clinical Trial Design, Scientific Publications, Communication Skills, Interpersonal Skills, Statistical Analysis, Endocrinology, Metabolic Disease, Project Management, Team Leadership

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 Sr Staff Clinical Scientist is a senior member of the Global Clinical Science team, focused on clinical strategy. As a Clinical Scientist, you will use your scientific, engineering, and expertise in medical device regulations to drive the clinical strategy of Dexcom products in support of Dexcom's product portfolio. Leading the development and design of clinical studies that establish the labeling, marketing claims and approval together with Commercial, R&D, Market Access, Medical Affairs and Product Marketing groups to fulfill the clinical strategy and develop plans, reports, and project deliverables. You will be responsible for interactions with global regulatory agencies as needed and will use your scientific and regulatory knowledge to provide directives to teams and study sites as needed. Where you come in: Drive the development of clinical strategy and trial design with cross-functional leaders from Commercial, Marketing, Medical Affairs, and R&D leadership. Provide input on best practices in medical device regulations in areas re: gold standard endpoints and outcome measures, scientific/ clinical evaluations, study instruments, questionnaires, and relevant standards for evaluating medical devices Inform 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, NP, and/or equivalent in endocrinology, metabolic disease or related field with extensive clinical research experience. 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: 15-25% Experience and Education Requirements: Typically requires a Bachelors degree, and a minimum of 13+ years related experience or a Masters degree and 8+ years equivalent industry experience of a PhD and 5+ years of experience. 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: $156,400.00 - $260,600.00

Responsibilities

Drive the development of clinical strategy and trial design with cross-functional leaders. Facilitate communication between various departments and conduct team meetings to present updates.