Clinical Dynamix, Inc.
Associate Director, Clinical Scientist
Clinical Dynamix, Inc. - Watertown, Massachusetts, United States, 02477
Work at Clinical Dynamix, Inc.
Overview
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Overview
Associate Director, Clinical Scientist
How youll 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 youll bring:
Bachelors 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.
How youll 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 youll bring:
Bachelors 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.