Associate Director, Clinical Quality Management

About Us  Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.   Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.   We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.   At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   These values are the foundation of our work, empowering us to make a real difference, every day.     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, 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 with 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 5+ years of pharmaceutical drug development experience in the biopharmaceutical/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 therapeutic area preferred Exact Compensation may vary based on skills, experience and location. Pay range $190,000—$240,000 USD

About Us  Kardigan is a heart health company working to make cardiovascular disease preventable, curable and no longer the leading cause of death in the world. It is Kardigan’s mission to develop multiple targeted treatments in parallel that bring people with cardiovascular diseases to the cures they deserve.   Led by Tassos Gianakakos, Jay Edelberg, M.D., Ph.D., and Bob McDowell, Ph.D., Kardigan’s co-founders have reunited after leading MyoKardia to discover and develop mavacamten, the first cardiac myosin inhibitor, resulting in an acquisition by Bristol Myers Squibb in 2020.   We have a cutting-edge discovery and translational research platform, a pipeline of late-stage candidates, and an industry-leading team that is driven to improve the lives of patients.   At Kardigan, we are motivated by our values which guide how we work, interact, and achieve our goals. Driven by patients and their families, we are deeply committed to improving the lives of patients and prioritizing their needs above all else. We believe in being authentic—leading with truth to bring out the best in others by creating an environment where every person knows they will be fully accepted. With an eagerness to learn, we encourage the highest levels of curiosity and are open to changing our minds. We are committed to winning as a team with urgency, excellence, and intention, and support each other no matter what role we play or where we sit. Lastly, we strive to enable the impossible because patients are counting on us. We are not afraid to take risks to unlock innovation and advance scientific discoveries.   These values are the foundation of our work, empowering us to make a real difference, every day.     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, 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 with 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 5+ years of pharmaceutical drug development experience in the biopharmaceutical/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 therapeutic area preferred Exact Compensation may vary based on skills, experience and location. Pay range $190,000—$240,000 USD