Associate Director, Clinical Research, Real-World Evidence

Sequel Med Tech

. Design and support real-world evidence studies, including research questions, endpoint definitions, analysis plans, data-quality review, interpretation, and results communication .

Posted 10/22/2026full-timeRemote • New Hampshire • United StatesSenior💰 $170,000 - $220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research design and execution, with a strong focus on real-world evidence methodologies and biostatistical principles. Proficient in developing clinical evidence materials and supporting regulatory submissions while effectively collaborating with cross-functional teams and external stakeholders.

Highest-signal resume keywords

Clinical Research DesignReal-World Evidence MethodsBiostatistical PrinciplesRegulatory SubmissionsScientific Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Study DesignObservational ResearchStatistical Analysis PlansData ReviewEndpoint SelectionSample-Size ConsiderationsLongitudinal Data AnalysisClinical Evidence DevelopmentEvidence SummariesRegulatory Requirements

Soft Skills

Strong CommunicationProject ManagementCross-Functional CollaborationIndependent WorkProblem-Solving

Certifications & Qualifications

PhDScDDrPHPharmDMDMS

Industry Keywords

Medical DevicePharmaceuticalBiotechnologyHealth Outcomes ResearchGood Clinical PracticeFDA ExpectationsDiabetes ManagementInsulin TherapyContinuous Glucose MonitoringAutomated Insulin Delivery Systems

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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