Associate Director, Clinical Research & Real-World Evidence

Sequel, headquartered in Manchester, New Hampshire, is a company developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel's approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel's flagship product, the twiist Automated Insulin Delivery (AID) System, launched in July 2025 for people with type 1 diabetes providing them with personalized diabetes management.

Responsibilities

Real-World Evidence & Biostatistics: Design and support RWE studies; contribute to research questions, endpoint definitions, analysis plans, data-quality review, interpretation, and communication of results; partner effectively with internal or external statisticians and data scientists; Study Design & Regulatory Support: Lead the development of study protocols and study concepts for company-sponsored, collaborative, post-market, and pivotal studies; develop clinical evidence for regulatory briefing materials, submissions, and responses; Clinical Research Execution: Drive study start-up and execution, including protocol and case-report-form development, vendor and investigator coordination, data review, issue resolution, analysis, and interpretation; Evidence Planning: Partner with the CMO to identify evidence gaps and research priorities and drive an integrated evidence-generation plan; Clinical Evidence Development: Develop clinical evidence materials, including competitive data comparisons, dossiers, evidence summaries, and scientific narratives; Payer / Market Access: Develop clinical and economic evidence summaries supporting reimbursement, payer engagements, and market-access activities; Publications & Scientific Communications: Support scientific publications, abstracts, posters, congress presentations, and dissemination of clinical and real-world evidence; Medical Affairs Strategy: Contribute to the execution of the Medical Affairs strategy and evidence roadmap; Medical Education & Scientific Engagement: Serve as a scientific resource across the product portfolio; support advisory boards, congress activities, medical education programs, and engagement with healthcare professionals, investigators, and key opinion leaders; Medical Safety: Participate in hazard analysis reviews, adverse-event and complaint evaluations for Sequel owned product, post-market safety activities, and related investigations

Requirements

Advanced degree in biostatistics, epidemiology, health outcomes research, clinical research, public health, or a relevant scientific or healthcare discipline (e.g., 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; a doctoral degree may substitute for a portion of professional experience; 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, and to collaborate effectively with statisticians and programmers; 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; 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

Nice to have

Direct experience supporting regulatory activities; Medical device experience; Knowledge of clinical research and regulatory requirements outside the U.S., including global or international evidence-generation activities; 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

Benefits

Automatic enrollment in 401k plan with 6% company match and 100% immediate vesting; Capped out-of-pocket insulin costs and GLP-1 coverage across all plans; Meritain health insurance plans; Flexible Spending Accounts (FSAs) or Health Savings Account (HSA); Vision and dental coverage; Voluntary long-term disability, accident, critical illness, hospital indemnity, and pet care discounts; Employer-paid short-term disability and life insurance; Flexible PTO, paid holidays, and Flex Time options