Associate Director, Clinical Scientist at Clinical Dynamix, Inc.

Associate Director, Clinical Scientist

How you’ll make an impact:

• Serve as the study lead Clinical Scientist in immunology, actively participating in program team meetings, scientific advisory boards, and data/safety monitoring committees.
• Support the design of clinical trial protocols, synopses, and amendments, ensuring scientific integrity and alignment with regulatory standards.
• Conduct clinical and medical data reviews, including safety monitoring activities, to ensure patient safety and data accuracy.
• Collaborate with Translational Medicine to embed bioanalytical sampling (e.g., PK/PD, biomarker assays) into trial protocols; ensure data flow to functional groups for analysis.
• Prepare and review essential documents such as medical monitoring plans, statistical analysis plans (SAPs), informed consent forms, and clinical study reports, supporting regulatory submissions.
• Work within a matrix environment, collaborating with medical directors, regulatory affairs, translational medicine, clinical operations, statistics, and other departments to drive clinical development programs forward.
• Review monitoring reports, track protocol deviations, monitor data, query resolution, analyze trends, and prepare clinical study reports and regulatory submission materials.
• Present data and information to external investigators and internal stakeholders, contributing to meetings with governance bodies and regulatory authorities.

Skills and experience you’ll bring:

• Bachelor’s or advanced degree (MSc, PharmD, MD, PhD) in Life Sciences, Pharmacology, or related field.
• 4+ years in pharmaceutical clinical drug development, with experience in global clinical trials and program execution.
• Proficiency in immunological diseases (e.g. Atopic dermatitis, Asthma) including an understanding of disease biology and treatment landscapes.
• In-depth understanding of clinical development processes, regulatory requirements, and guidelines (FDA, EMEA, ICH, GCP).
• Strong problem-solving abilities and excellent medical writing skills.