Senior Clinical Scientist, Immunology & Trials Lead

Clinical Dynamix, Inc.; Watertown (MA); Sur place; USD 170 000 - 230 000; Plein temps

Résumé du poste

Clinical Dynamix, Inc. is seeking an Associate Director, Clinical Scientist to lead immunology program work in a cross-functional team environment in Watertown, MA.

You will shape protocol designs, review safety data, and ensure regulatory-aligned study documentation. In this role, you’ll partner with Translational Medicine and medical directors to embed bioanalytical sampling, monitor data quality, and prepare study reports for regulatory submissions, contributing to program success and

Qualifications

• Bachelor’s or advanced degree in life sciences or related field.
• 4+ years in pharmaceutical clinical drug development with global trial experience.
• Experience with immunological diseases and understanding of biology and treatment landscapes.
• Strong knowledge of clinical development processes, regulatory requirements (FDA/EMEA/ICH/GCP).
• Excellent medical writing and problem-solving abilities.

Responsabilités

• Lead as the study Clinical Scientist in immunology, participating in program teams and governance.
• Design and review clinical protocols, synopses, amendments, and regulatory-aligned documents.
• Perform clinical data reviews and safety monitoring to ensure patient safety and data accuracy.
• Collaborate with Translational Medicine to embed bioanalytical sampling into trials.
• Prepare documents like medical monitoring plans, SAPs, ICFs, and study reports for submissions.
• Work in a matrix with medical directors, regulatory affairs, statistics, and operations to drive programs.
• Review monitoring reports, deviations, data trends, and create regulatory submission materials.
• Present data to external investigators and internal stakeholders and participate in governance meetings.

Description du poste

Clinical Dynamix, Inc. is seeking an Associate Director, Clinical Scientist to lead immunology program work in a cross-functional team environment in Watertown, MA.

You will shape protocol designs, review safety data, and ensure regulatory-aligned study documentation. In this role, you’ll partner with Translational Medicine and medical directors to embed bioanalytical sampling, monitor data quality, and prepare study reports for regulatory submissions, contributing to program success and