Senior Staff Clinical Scientist
Dexcom
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $156,400 - $260,600 per year
Job Level
Senior
Tech Stack
Python
About the role
- 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
- Facilitate 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
- Participate 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
- Facilitate regulatory submissions and communications by communicating with Regulatory Affairs during the submission process
- Interpret results in preparation for product applications by evaluating clinical and scientific and risk data and literature and staying abreast of current clinical practice
Requirements
- 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
- Advanced Programming Skills (Python, R, SPSS, SAS, MatLab, Etc) and demonstrated advanced statistical analysis experience (optional but nice to have)
- Experience in the European market (optional but nice to have)
- Ability to work in a matrixed organization
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical strategy developmenttrial designmedical device regulationsclinical evaluationclinical trial protocolsdata analysisstatistical analysismedical writingregulatory submissionsclinical research
Soft skills
communication skillsinterpersonal skillssimplifying complex conceptsteam collaborationpresentation skillsleadershiporganizational skillscross-functional collaborationproblem-solvingadaptability
Certifications
PhDMDNP