Associate Director, Clinical Research & Real-World Evidence

About Sequel

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, including objectives, populations, comparators, endpoints, sample-size considerations, and analysis approaches; 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 and 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 supporting regulatory, reimbursement, product adoption, medical education, publications, and OUS opportunities.
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, supporting clinical adoption, reimbursement, patient outcomes, and future growth objectives.
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.

Minimum Requirements

Education: 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).
Experience: 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; direct experience supporting regulatory activities is preferred.

Required Knowledge, Skills and Abilities

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 to collaborate effectively with statisticians and programmers.
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; 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, 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.

Originally posted on Himalayas