Associate Director, Clinical Scientist
KardiganAbout the role
About Us
Position Title: Associate Director, Clinical Scientist
Department: Clinical Development
Reports To: VP, Clinical Development Lead (CDL) for each program
Job Overview
The Associate Director, Clinical Scientist will play a critical role in the analysis and monitoring of research study data, in all phases of development for company-developed assets in cardiovascular disease, and in support of phase 2B and large phase 3 clinical trials. This role will report to the VP, Clinical Development Lead (CDL) for each program and will collaborate closely with colleagues on the program governance team (e.g., Global Program Team) from clinical development, clinical operations, data management, statistics, regulatory, medical affairs, and pharmacovigiliance. The Associate Director, Clinical Scientist will be instrumental in providing comprehensive clinical trial data reviews, interpreting complex data sets, and creating high-impact scientific content to progress Kardigan’s clinical programs and trials.
Essential Duties and Responsibilities
- Partner with VP-CDL and the broader cross-functional governance team members from the Global Project Team (GPT) and the Clinical Strategy Team (CST) in the planning and execution of clinical research studies.
- May function as Lead Clinical Scientist for a program driving the development, planning, and execution of clinical studies. This includes the development of clinical study documents such as study protocols, amendments, statistical analysis plans, and clinical trial site/patient-facing materials.
- Ensures the quality and scientific integrity in the monitoring and interpretation of study data of a clinical development program.
- Maintains proficient understanding of therapeutic disease area(s) and drug candidates including underlying disease biology, and up-to-date knowledge of relevant scientific literature, therapeutic area trends, and regulatory requirements impacting clinical trials and drug development.
- Exhibits strong analytical knowledge and skills to understand how study objectives and design impact data analysis; supports identification and/or identifies critical risks and mitigations
- Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
- Partnership with data management, statistics, and drug safety teams to integrate pharmacokinetic, clinical efficacy, and safety data into overall clinical study designs.
- Develops the Expanded Protocol Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments.
- Authors and/or reviews documents related to trials, such as medical monitoring and data monitoring plans, statistical analysis plans, informed consent forms, an
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