Associate Director, Clinical Research & Real-World Evidence

Sequel Med Tech•Manchester, NH

4d•$170,000 - $220,000

About The Position

The Associate Director, Clinical Research and Real-World Evidence is a hands-on scientific contributor who drives and executes clinical research, real-world evidence (RWE), biostatistical planning and interpretation, and other evidence-generation activities across Sequel Med Tech's product portfolio, including the twiist Automated Insulin Delivery (AID) System. Working closely with the Chief Medical Officer and cross-functional partners, this role translates clinical and business questions into rigorous, feasible research plans and helps generate evidence to support product development, regulatory activities, reimbursement, clinical adoption, and scientific dissemination. The role independently contributes to protocol development, endpoint selection, statistical analysis plans, interpretation of clinical and real-world data, and study execution, while collaborating with the CMO and subject-matter experts on broader evidence strategy. It works with internal teams and external investigators, academic research organizations, analytics partners, and research vendors. Experience supporting medical device regulatory submissions or working in a regulated environment is preferred.

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).
At least 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 collaborate effectively with statisticians and programmers.
Experience supporting clinical research execution, including investigator or vendor collaboration, data review, and interpretation of study findings.
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 Haves

Direct experience supporting regulatory activities.
Familiarity with FDA expectations, Good Clinical Practice, and clinical evidence requirements for regulated products; medical device experience is preferred.
Knowledge of clinical research and regulatory requirements outside the U.S., including experience supporting 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.

Responsibilities

Design and support RWE studies, contributing to research questions, endpoint definitions, analysis plans, data-quality review, interpretation, and communication of results; collaborate with internal or external statisticians and data scientists.
Lead development of study protocols and concepts for company-sponsored, collaborative, post-market, and pivotal studies, including objectives, populations, comparators, endpoints, sample-size considerations, and analysis approaches.
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 across company-sponsored studies, investigator-initiated studies, and special-population research.
Partner with the CMO to identify evidence gaps and research priorities and drive an integrated evidence-generation plan covering clinical studies, RWE, publications, and external collaborations.
Develop clinical evidence materials, including competitive data comparisons, dossiers, evidence summaries, and scientific narratives for regulatory, reimbursement, product adoption, medical education, publications, and OUS opportunities.
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 execution of the Medical Affairs strategy and evidence roadmap, supporting clinical adoption, reimbursement, patient outcomes, and future growth objectives.
Serve as a scientific resource across the product portfolio and 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 for Sequel-owned products, post-market safety activities, and related investigations.

Benefits

401(k) plan with a 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, and hospital indemnity coverage.
Discounts for pet care.
Employer-paid short-term disability and life insurance.
Flexible PTO.
Paid holidays.
Flex Time options.