Senior Manager, Clinical Scientist

Position Title:  Senior Manager, Clinical Scientist

Department: Clinical Development

Reports To: VP, Clinical Development Lead (CDL) for each program

Job Overview

The Senior Manager, 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 Senior Manager, 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, and clinical components of the Clinical Study Reports and supports the development of regulatory documents while ensuring adherence to Good Clinical Practices (GCP).
• Supports Data Monitoring Committees, Safety Review Committees, or other applicable data review committees including committee charter development, preparing updates and data reviews, facilitation of meetings, and communication of synthesized data reports.
• Provides support for review of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, visualizing, interpreting, and summarizing data reports

Qualifications and Preferred Skills

• Advanced degree or equivalent education/degree in life science/healthcare (PhD, MD, PharmD) preferred with 3+ years of pharmaceutical drug development experience in clinical operations, clinical development, medical affairs, or regulatory affairs, preferably within the biopharmaceutical or biotechnology industry
• Familiarity with clinical trial design principles, clinical trial operational execution, and regulatory requirements (e.g., FDA, EMA).
• Strong understanding of biostatistics and experience in interpreting clinical trial data
• Proficiency in medical writing and developing high-quality scientific documents.
• Familiarity with Good Clinical Practices (GCP) and experience in ensuring compliance with GCP guidelines in scientific writing and publication.
• Proven ability to create and generate scientific presentations for consumption by diverse audiences.
• Excellent organizational, interpersonal, and communication skills.
• Must be willing and possess the expertise to work effectively in a fast-paced, team-based matrix environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
• Experience in the Cardiovascular therapy area preferred