Lead, Clinical Research & Real‑World Evidence

OpenKrill; USA; Remote; USD 140.000 - 210.000; Vollzeit

Benefits dieser Stelle

401k with company match

Insulin cost coverage

GLP-1 coverage

Vision and dental coverage

FSAs/HSA

Zusammenfassung

Sequel Med Tech in Manchester, NH seeks an Associate Director of Clinical Research and Real-World Evidence to drive evidence generation across the product portfolio, including the twiist Automated Insulin Delivery system.

The role collaborates with the CMO and cross-functional partners to translate questions into robust study plans and supports regulatory submissions, reimbursement strategy, and scientific dissemination.

Qualifikationen

• Advanced degree in biostatistics, epidemiology, health outcomes research, clinical research, public health, or a relevant scientific discipline.
• 5+ years in clinical research, RWE, biostatistics, epidemiology, or medical device/pharma evidence generation.
• Experience in regulated medical device or pharmaceutical environments; regulatory support preferred.

Aufgaben

• Design and support Real-World Evidence studies and biostatistical analyses.
• Lead protocol development and study concepts for company-sponsored and post-market trials.
• Drive study start-up, vendor coordination, data review, and interpretation across studies.
• Identify evidence gaps with the CMO and develop an integrated evidence-generation plan.
• Develop clinical evidence materials for regulatory, reimbursement, and market adoption.

Kenntnisse

Biostatistics

Epidemiology

Real‑world evidence

Clinical research

Regulatory knowledge

FDA expectations

Communication

Project management

Scientific writing

Diabetes knowledge

Ausbildung

PhD/DrPH/MD/MS

MS/MS in relevant field

Jobbeschreibung

Sequel Med Tech in Manchester, NH seeks an Associate Director of Clinical Research and Real-World Evidence to drive evidence generation across the product portfolio, including the twiist Automated Insulin Delivery system.

The role collaborates with the CMO and cross-functional partners to translate questions into robust study plans and supports regulatory submissions, reimbursement strategy, and scientific dissemination.