Job description
LuminaBio Medical Institute seeks a Senior Medical Scientist in Specialized Medicine to lead strategic clinical research initiatives in a fast-paced, collaborative environment in Boston. This role focuses on translating cutting-edge diagnostics and therapies into tangible patient outcomes.
In this position, you will design and oversee multi-disciplinary studies, guide data quality, and partner with clinicians, biostatisticians, and regulatory teams to advance personalized medicine. You will have access to state-of-the-art genomics platforms, AI-driven analytics, and a supportive culture that values scientific excellence and patient impact.
Ideal candidates are seasoned researchers who can navigate complex regulatory landscapes, mentor junior staff, and communicate complex findings to diverse audiences.
Responsibility
- Lead end-to-end design and execution of clinical studies within Specialized Medicine, from protocol development to data analysis and reporting.
- Develop robust study plans, endpoints, inclusion/exclusion criteria, and biospecimen workflows.
- Ensure regulatory compliance, quality systems, GxP documentation, and trial governance.
- Collaborate with clinicians, biostatisticians, bioinformaticians, and regulatory affairs to translate findings into patient-centered diagnostics and therapies.
- Mentor junior scientists and coordinate cross-functional teams to meet milestones and budgets.
- Oversee data integrity, statistical analyses, and scientific writing for publications and regulatory submissions.
- Present findings to internal leadership and external stakeholders; contribute to grant applications and business development.
Qualification
- PhD in Biomedical Science, Medicine, or related field; MD/DO with research experience acceptable; at least 5 years of clinical research or diagnostic development in Specialized Medicine.
- Strong experience in clinical trial design, biostatistics, data management, and regulatory affairs (IRB/IND/CTA).
- Proven track record of publications and presentations in high-impact venues; experience with regulatory submissions is a plus.
- Excellent leadership, project management, and cross-functional collaboration skills.
- Proficiency with data analysis tools (R, Python, SAS) and medical writing; experience with real-world evidence is a plus.
- Knowledge of GMP/GLP, quality systems, and risk management in biomedical research.
- Excellent communication skills; ability to convey complex scientific concepts to clinicians and executives.