One Drop is seeking a Clinical Scientist, who will lead device trial strategy and study designs/ protocols to support regulatory approval (IRB, FDA) as well as device and program evidence generation for stakeholders including but not limited to engineers, investors, partners, employers, health plans, health systems and individual consumers.

You’ll make an impact by:

• Applying experience and expertise, along with input from industry and scientific experts, to development of comprehensive pre-clinical and clinical trial strategy aimed at generating the evidence required for device development, regulatory approval in the US and internationally and maintaining regulatory approvals.
• Developing study designs, protocols and plans to support overarching clinical strategy, incorporating input from leadership, consultants and other experts. 
• Developing requests for proposals and evaluating vendor proposals, researching feasibility and the research partner landscape 
• Performing medical and scientific review of study plans, materials and deliverables created by CRO’s to ensure studies achieve regulatory and business goals, including but not limited to review and input into clinical study protocols, informed consent forms, investigator brochures, data management plans, case report forms, clinical study reports, TFL shells, TFLs, and other study documentations and publications. Providing scientific support for the site selection process and for site recruitment questionnaire development.
• Serving as the scientific point of contact providing scientific assistance and support for the study teams who oversee trials, providing clinical, therapeutic and scientific expertise to the study team and supporting the creation of trial deliverables and providing scientific support for the site selection process and for site recruitment questionnaire development. 
• Performing medical and clinical research data review, including but not limited to assessments of safety and efficacy data, patient demographics, medical and disease history, concomitant medications, laboratory values, adverse events, disease response verification, and overall review to ensure that the data is coherent, complete, and accurate so that it is suitable to meet study deliverables. 
• Creating data summaries and assists in the development and preparation of scientific manuscripts, abstracts, poster and oral presentations, and other meetings in collaboration with Study Chairs and/or sponsors, as requested.
• Following standard operating procedures, ICH-GCP, and all applicable regulatory requirements.

You’ll bring:

• 
  

Must-Haves:

• Master’s Degree required; PhD preferred
• Minimum 3 years of experience in clinical research and/or laboratory-based research (human subjects research), with experience in an academic or community medical center (medical science), or in the pharmaceutical, biotechnology, contract research (CRO) industry or similar research entity preferred

Bonus Points: 

• Experience in endocrinology clinical research and/or endocrinology-focused laboratory-based research, with experience in an academic or community medical center, or in the pharmaceutical, biotechnology, contract research industry or similar research entity preferred. 
• Familiarity with medical data review is preferred. 

You’ll get:

• To deeply impact the lives of people with chronic conditions
• The opportunity to contribute at an early stage startup and help develop the future of healthcare
• Competitive salary and equity commensurate with experience and performance
• Medical, Dental, and Vision insurance and 401k plan
• Yearly Professional Development budget
• Unlimited vacation days

One Drop is the future of healthcare. Our mission is to develop technology that ensures all people living with diabetes and other chronic conditions can thrive. We harness the power of data science and mobile computing to make healthcare more affordable, accessible, and effective. 

Our clinically proven mobile platform combines AI-powered predictive insights, personalized health coaching, and FDA-approved connected devices to simplify self-care. And it works. People using the One Drop platform have seen significant improvements in their health in just a few weeks.

Today, the rate of people living with chronic conditions is increasing dramatically, and traditional approaches to healthcare cannot possibly scale to reach them all. We exist to serve those people and help them lead their best lives. www.onedrop.today

At One Drop, we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. One Drop provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. Diversity of experience and skills combined with passion is a key to innovation and excellence. Therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodations during the interview process.

To all recruitment agencies: One Drop does not accept unsolicited agency resumes. Please do not forward resumes to our jobs alias or One Drop employees. One Drop is not responsible for any fees related to unsolicited resumes.