Clinical Research & Real-World Evidence Lead

Sequel Med Tech, LLC; Manchester (NH); On-site; USD 170,000 - 220,000; Full time

Benefits offered by this job

401k with 6% match

GLP-1 coverage

Vision and dental

FSAs/HSA

Short-term disability

Life insurance

Flexible PTO & holidays

Job summary

Sequel Med Tech, LLC in Manchester, NH is seeking an Associate Director of Clinical Research and Real-World Evidence to drive RWE, biostatistics, and regulatory-supported research for its twiist Automated Insulin Delivery system.

The role collaborates with the CMO and cross-functional teams to translate clinical questions into rigorous study plans, manage study execution, and develop evidence for regulatory, reimbursement, and adoption purposes.

Qualifications

• Strong knowledge of clinical study design, observational research, registry studies, and real-world evidence methods.
• Applied understanding of biostatistical principles: endpoints, power, missing data, bias mitigation.
• Ability to develop or review protocols, SAPs, tables/figures, and study reports.

Responsibilities

• Design and support RWE studies; define endpoints, analysis plans, and data quality.
• Lead protocol and study concept development for company-sponsored and pivotal studies.
• Drive start-up and execution of studies including vendor coordination and data review.
• Identify evidence gaps with the CMO and develop an integrated evidence-generation plan.
• Develop clinical evidence materials for regulatory, reimbursement, and publication needs.
• Support payer and market access with clinical/economic evidence summaries.
• Contribute to scientific publications, abstracts, posters, and congress materials.
• Support Medical Affairs strategy and education programs across product portfolio.
• Participate in safety reviews and post-market activities for Sequel products.

Skills

Clinical study design

Observational research

Biostatistics

Regulatory knowledge

Scientific writing

Education

Advanced degree in biostatistics/epidemiology/health outcomes/clinical research/public health

Job description

Sequel Med Tech, LLC in Manchester, NH is seeking an Associate Director of Clinical Research and Real-World Evidence to drive RWE, biostatistics, and regulatory-supported research for its twiist Automated Insulin Delivery system.

The role collaborates with the CMO and cross-functional teams to translate clinical questions into rigorous study plans, manage study execution, and develop evidence for regulatory, reimbursement, and adoption purposes.