Director Clinical Scientist

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 tu