Based in San Diego, CA, Biological Dynamics, Inc. (BioDyn) is a privately held molecular diagnostics company and a pioneer in the field of Alternating Current Electrokinetics(ACE)-based diagnostics. At BioDyn, we are developing novel diagnostic solutions to screen, diagnose and manage high burden conditions, such as cancer. Our diverse team shares a passion for improving patient care, a focus on cutting-edge technology, and a deep commitment to innovation, which shapes the future of our company and drives our innovative culture. To learn more about BioDyn, please visit our website, www.BiologicalDynamics.com, or feel free to view a TEDx Talk given by BioDyn’s Co-founder and CEO, Dr. Raj Krishnan, at https://www.youtube.com/watch?v=wMsOYqJ4ShA.
As part of our company’s commitment to developing and delivering to the market a suite of high-performance products, we have an openingfor aClinical Project Manager, for which candidates available on a temporary and/or part-time basis will be considered alongside those applying for the permanent, full-time position. The individual in this key role will have primary responsibility for the design, set-up, maintenance, and close out of all of the company’s clinical studies and trials. As well, s/he will work with other members of staff to manage databases of clinical trial-related information and inventories of clinical samples.As a team member within this small but growing company, the individual will have an opportunity to make a major contribution to the successful development and commercialization of a novel technology.
• Manage all partnerships with the company’s external clinical sites, including communicating and meeting with staff at the sites on a regular and an ad hoc basis;
• Use knowledge of clinical trial inclusion and exclusion criteria in order to design successful clinical trials and studies;
• Coordinate logistics on sample transportation and handling;
• Manage databases of clinical information, and partner on sample accessioning and tracking;
• Partner with other members of the Team on managing interactions with external CROs;
• Contribute to defining project scope, budgets, and timelines, and monitor ongoing activities to ensure that efforts are successful and within budget;
• Ensure that projects comply with all relevant SOPs, regulations, and quality standards;
• Report on progress and issues with clinical trials and studies on a regular and/or as-needed basis;
• Contribute to process improvements in all areas related to clinical trials and studies; and
• Other duties as assigned.
• Bachelor’s degreeor equivalent in the Health Sciences or Biological Sciences;
• 2 to 5 years of experience managing clinical trials, at a clinical site, sponsor institution or CRO, highly desirable;
• Direct experience with IVDs or medical devices highly preferred;
• Experience in handling datasets for clinical studies, with direct knowledge of databases highly preferred;
• Knowledge of cancer biology and/or therapeutics is a plus;
• Ability to generate reports, present within the organization,and make external presentations preferred;
• Strong verbal and written communication skills;
• Willingness to travel to clinical sites, both locally and elsewhere in the US, as needed; and
• Ability to exercise discretion with regard to the confidentiality of patient information, per HIPAA and other guidelines.
About Biological Dynamics
Biological Dynamics is a private molecular diagnostics company located in San Diego. Founded in 2010, based on innovation developed at UC San Diego’s Jacobs School of Engineering, the company is pursuing the use of ACE technology to improve detection, treatment and monitoring of cancers. Biological Dynamics first product, the OncoState™ Lung assay, will utilize the platform to support treatment response in for patients with Non-Small Cell Lung Cancer.