[Hiring] Associate Director, Clinical Research & Real-World Evidence @Sequel Med Tech

Role Description

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.

Job Responsibilities and Essential Duties

• 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 across company-sponsored studies, investigator-initiated studies, and special-population research
• Evidence Planning:
  • Partner with the CMO to identify evidence gaps and research priorities
  • Drive an integrated evidence-generation plan spanning clinical studies, real-world evidence, publications, and external collaborations
• 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

Qualifications

• 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
• Experience in a regulated medical device, pharmaceutical, biotechnology, academic research, contract research, or health-data environment

Requirements

• 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.
• 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

• 401k plan with a 6% company match and 100% immediate vesting
• Capped out-of-pocket insulin costs and GLP-1 coverage across all plans
• Access to a variety of Meritain health insurance plans
• Flexible Spending Accounts (FSAs) or Health Savings Account (HSA)
• Vision and dental coverage, plus voluntary options such as long-term disability, accident, critical illness, hospital indemnity, and discounts for pet care
• Employer-paid short-term disability and life insurance
• Flexible PTO, generous paid holidays, and Flex Time options

Environmental/Safety/Physical Work Conditions

• Ensures environmental consciousness and safe practices are exhibited in decisions
• Use of computer and telephone equipment and other related office accessories/devices to complete assignments
• May work extended hours during peak business cycles
• Physical requirements such as lifting specific weights
• Some travelling is expected