Associate Director, Clinical Scientist

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

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.