Associate Director, Clinical Research, Real-World Evidence

This is a fully remote position, open to applicants in New Hampshire.

📋 Description

• Design and provide support for real-world evidence studies, encompassing research questions, endpoint definitions, analysis plans, data-quality assessment, interpretation, and communication of results.

• Create study protocols and concepts for company-sponsored, collaborative, post-market, and pivotal studies.

• Generate clinical evidence for regulatory briefing materials, submissions, and responses.

• Oversee study initiation and execution, which includes protocol and case-report-form development, vendor and investigator coordination, data review, issue resolution, analysis, and interpretation.

• Collaborate with the Chief Medical Officer to identify evidence gaps and research priorities while advancing an integrated evidence-generation plan.

• Produce clinical evidence materials, competitive data comparisons, dossiers, evidence summaries, and scientific narratives.

• Formulate clinical and economic evidence summaries that support reimbursement, payer engagements, and market-access initiatives.

• Assist in the development of scientific publications, abstracts, posters, congress presentations, and dissemination of clinical and real-world evidence.

• Contribute to the Medical Affairs strategy and evidence roadmap.

• Support advisory boards, congress activities, medical education programs, and foster 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

• An 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.

• A minimum of 5 years of relevant experience in clinical research, real-world evidence, biostatistics, epidemiology, medical device or pharmaceutical evidence generation, or a related field.

• Experience in a regulated environment related to medical devices, pharmaceuticals, biotechnology, academic research, contract research, or health data.

• Comprehensive knowledge of clinical study design, observational research, registry studies, and methods for real-world evidence.

• 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.

• Capability to develop or critically assess protocols, statistical analysis plans, tables and figures, and study reports.

• Experience in supporting clinical research execution, which includes collaboration with investigators or vendors, data review, and interpretation of study findings.

• Familiarity with FDA expectations, Good Clinical Practice, and clinical evidence requirements for regulated products.

• Preference for knowledge of clinical research and regulatory requirements outside the U.S., including global or international evidence-generation activities.

• Experience in preparing abstracts, posters, manuscripts, evidence summaries, or other scientific communications.

• Preferred knowledge of diabetes management, insulin therapy, continuous glucose monitoring, and Automated Insulin Delivery systems.

• Strong skills in scientific writing, communication, project management, and cross-functional collaboration.

• Ability to work independently, manage multiple research activities, and convert evidence into clear scientific, clinical, and business insights.

🏝️ Benefits

• 401(k) plan featuring a 6% company match with 100% immediate vesting.

• Capped out-of-pocket insulin costs.

• GLP-1 coverage available across all plans.

• Meritain health insurance plans.

• Flexible Spending Accounts (FSAs).

• Health Savings Account (HSA).

• Vision and dental coverage.

• Optional long-term disability coverage.

• Accident coverage.

• Critical illness coverage.

• Hospital indemnity coverage.

• Discounts for pet care.

• Employer-paid short-term disability insurance.

• Employer-paid life insurance.

• Flexible Paid Time Off (PTO).

• Generous paid holidays.

• Options for Flex Time.