Director of Clinical Studies

Requirements

• Bachelor's Degree, preferably in biological science, nursing, dietetics, life sciences, or medical science
• Minimum of 3 years experience in clinical trial coordination/program/project management
• Minimum of 3 years experience in a clinical organization
• Knowledge and experience of ICH GCP standards
• Experience with Investigator Brochures as well as Investigational New Drug Applications
• Ability to understand and carefully follow regulatory guidelines, procedures and safety guidelines related to clinical trials research
• Excellent organizational skills with attention to detail
• Strong communication and critical thinking skills actively contributing ideas, energy and desire to succeed as a team with a strong personal and professional drive to get things done
• Ability to master new systems quickly and adapt to constantly changing needs
• Experience in establishing the infrastructure required to implement and execute efficient clinical studies
• Data oriented, with the ability to quickly learn new systems and applications. Preferred experience with electronic data capture (EDC) or electronic survey tools, such as Qualtrics
• Experience working with project tracking software such as Asana, Jira, etc.
• Flexibility to think and work outside the box in the design, conduct and implement clinical trials including the willingness to explore novel approaches to the conduct of studies
• Proficient scientific and clinical understanding of microbiome science or the willingness and ability to learn quickly
• Experience in implementing and prioritizing work across multiple projects under tight time constraints

Additional Information

About Pendulum: Pendulum is on a mission to help people improve physical and mental health by creating a new category of products that target the microbiome. We are researching, developing and commercializing a novel class of rationally-designed Live Synbiotics (probiotics + prebiotics) that have demonstrated utility in addressing conditions like metabolic syndrome, inflammation and neurodegeneration. Pendulum has created a unique discovery platform that utilizes genome sequencing and advanced computational approaches to identify novel, proprietary bacterial strains that augment key functions within the gut microbiome relevant to the respective disease state. We are a highly collaborative team of scientists, engineers, physicians, manufacturing professionals, and marketing specialists interested in improving human health by leveraging the latest research from diverse fields, such as microbiology, molecular biology, high-throughput genomics, distributed computing, pharmaceutical development and nutrition. We believe strongly in an individual's transparency and strong communication to enable the most effective and efficient path to team success. If you're interested in building a new category of products that will help improve the lives of people globally and you love working in a fast-paced, cross-functional, collaborative, inspiring environment, please continue reading! Position Summary: Pendulum is seeking an Director of Clinical Studies to support the clinical team and contribute to the generation of clinical data to support current and future innovative microbiome-based products. In this position, the candidate will work directly with the Chief Medical Officer to support the execution of a wide variety of clinical research activities including the management of clinical health surveys, execution of clinical trials and external clinical collaborations. The candidate should be a self-starter with expert attention to detail and coordination skills. The candidate will oversee the design and management of clinical health surveys, customer studies and clinical trial planning, design, preparation, management, evaluation and documentation.

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