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Associate Director, Clinical Research, Real-World Evidence

Job not on LinkedIn

🔥 2 minutes ago

🗻 New Hampshire – Remote

infoinfo

đź’µ $170k - $220k / year

⏰ Full Time

đźź  Senior

đź§Ş Clinical Research

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Logo of Sequel Med Tech

Sequel Med Tech

201 - 500 employees

Founded 2023

🏥 Healthcare

🏭 Manufacturing

đź”§ Hardware

Healthcare • Manufacturing • Hardware

Sequel Med Tech is a medical technology company developing automated insulin delivery (AID) systems to improve diabetes care. Its flagship product, the twiist™ AID system (FDA-cleared for ages 6+), directly measures insulin volume delivered with every microdose and uses the Tidepool/Loop algorithm to automate basal insulin adjustments. Sequel focuses on making AID more accessible and affordable via pharmacy channels, partners with research and pharma organizations (including DEKA/Dean Kamen collaborators), and serves people with diabetes, healthcare providers, employers, and pharmaceutical partners.

đź“‹ Description

• Design and support real-world evidence studies, including research questions, endpoint definitions, analysis plans, data-quality review, interpretation, and results communication • Develop study protocols and concepts for company-sponsored, collaborative, post-market, and pivotal studies • Develop clinical evidence for regulatory briefing materials, submissions, and responses • Drive study start-up and execution, including protocol and case-report-form development, vendor and investigator coordination, data review, issue resolution, analysis, and interpretation • Partner with the CMO to identify evidence gaps and research priorities and drive an integrated evidence-generation plan • Develop clinical evidence materials, competitive data comparisons, dossiers, evidence summaries, and scientific narratives • Develop clinical and economic evidence summaries supporting reimbursement, payer engagements, and market-access activities • Support scientific publications, abstracts, posters, congress presentations, and dissemination of clinical and real-world evidence • Contribute to Medical Affairs strategy and evidence roadmap • Support advisory boards, congress activities, medical education programs, and engagement with healthcare professionals, investigators, and key opinion leaders • Participate in hazard analysis reviews, adverse-event and complaint evaluations, post-market safety activities, and related investigations • Collaborate with the Chief Medical Officer, internal teams, external investigators, academic research organizations, analytics partners, and research vendors

🎯 Requirements

• Advanced degree in biostatistics, epidemiology, health outcomes research, clinical research, public health, or a relevant scientific or healthcare discipline, such as PhD, ScD, DrPH, PharmD, MD, or MS • 5+ years of relevant experience in clinical research, RWE, biostatistics, epidemiology, medical device or pharmaceutical evidence generation, or a related field • Experience in a regulated medical device, pharmaceutical, biotechnology, academic research, contract research, or health-data environment • Strong knowledge of clinical study design, observational research, registry studies, and real-world evidence methods • Applied understanding of biostatistical principles, including endpoint selection, sample-size and power considerations, longitudinal and repeated-measures data, missing data, confounding, bias mitigation, and interpretation of clinical and real-world analyses • Ability to develop or critically review protocols, statistical analysis plans, tables and figures, and study reports • Experience supporting clinical research execution, including investigator or vendor collaboration, data review, and interpretation of study findings • Familiarity with FDA expectations, Good Clinical Practice, and clinical evidence requirements for regulated products • Knowledge of clinical research and regulatory requirements outside the U.S., including global or international evidence-generation activities, is preferred • Experience preparing abstracts, posters, manuscripts, evidence summaries, or other scientific communications • Knowledge of diabetes management, insulin therapy, continuous glucose monitoring, and Automated Insulin Delivery systems is preferred • Strong scientific writing, communication, project management, and cross-functional collaboration skills • Ability to work independently, manage multiple research activities, and translate evidence into clear scientific, clinical, and business insights

🏖️ Benefits

• 401(k) plan with a 6% company match and 100% immediate vesting • Capped out-of-pocket insulin costs • GLP-1 coverage across all plans • Meritain health insurance plans • Flexible Spending Accounts (FSAs) • Health Savings Account (HSA) • Vision and dental coverage • Voluntary long-term disability coverage • Accident coverage • Critical illness coverage • Hospital indemnity coverage • Pet care discounts • Employer-paid short-term disability insurance • Employer-paid life insurance • Flexible PTO • Generous paid holidays • Flex Time options

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