Director of Clinical Studies

Job description

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. What You'll Do: Create, update, and manage clinical health surveys, oversee data integrity, and coordinate and oversee data analysis efforts through dashboard development and reporting, with the goal of achieving actionable insights, marketing claims generation and exploratory signals to inform future clinical trials Support customer studies to enable claims and new insights for product, marketing and revenue teams Coordinate and support several concurrent clinical research activities, including contributing to protocol design, day to day operations, and data collection & management. This will include single-site, multi-site and investigator-initiated trials with the aim of building scientific credibility and insights for Pendulum products. Act as a liaison between internal teams and outside clinical collaborators while overseeing protocol adherence and compliance, addressing any issues related to study products (product labeling, shipments, storage, etc), procedures, participant issues or adverse events, and manage external vendor relationships, as needed. Help assure compliance with all relevant regulatory agencies, implement and maintain periodic quality control procedures, and maintain regulatory documentation Ensure all clinical trial activities remain in compliance with Good Clinical Practice (GCP) Coordinate internal activities and communications including clinical team meetings, manage action items, track research progress, budget and quality standards. Coordinate and support the internal and external review of clinical study protocols, amendments and related documents, informed consent forms, study operations manuals, monitoring plans, and other study essential documents. Support and track IRB submissions and approvals Support clinical site management including taking an active role in site selection, training, timely entry of data into the study database and management of CRA clinical site monitoring visits. Collaborate with in-house marketing and creative team on asset development related to clinical activities, including but not limited to conference collateral, presentations, white papers, case studies, blog posts, email communication, and website copy Support a cross-functional team, including the Revenue team, Marketing, Manufacturing, Data, and Research & Development Knowledge 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 Demonstrated ability to work independently and be a true "Team Player" who can work cross-functionally to achieve results in a fast paced environment Salary & Benefits $223,200-$248,000 Medical, Dental, and Vision Commuter Benefits Life & STD Insurance Company match on 401 (k) Flexible Time Off (FTO) Equity