Medical Director

Summary

Join DELFI Diagnostics as a Medical Director I and collaborate internally and externally to develop, implement, and oversee clinical trials and research. Drive scientific planning, strategy, and clinical management of multiple external collaborations and trials. Provide medical oversight of trials, collaborate with investigators and advisors, and execute medical monitoring activities. Advise the DELFI Clinical Operations team and sites, assist cross-functional teams with medical issues, and serve as a clinical expert on DELFI technologies. Contribute to protocol, monitoring plan, and CRF development for clinical trials. Answer medical questions from sites, respond to safety questions and protocol deviations, and participate in investigator meetings. Establish relationships with clinical institutions and investigators, regularly organize investigator meetings, and engage expert advisors. Ensure execution of clinical trials, provide project team training, and support the achievement of key product corporate goals.

Requirements

• Medical Degree (M.D. or D.O.) with 2+ years of experience in clinical development
• Prior medical practice and fully trained in all aspects of clinical trials
• Clinical data review experience
• Thorough knowledge of the investigational product(s), the protocol, applicable SOPs, GCP, data privacy laws, and local regulatory requirements

Responsibilities

• Serve as expert clinical contributor within company regarding clinical use and enhancements of current and potential Delfi technologies
• Responsible for the clinical and scientific execution of clinical protocol(s) in DELFI sponsored trials and research collaborations
• Contribute to the protocol, monitoring plan, and CRF development for DELFI sponsored clinical trials by working collaboratively with Clinical Operations, Clinical Data Management, Statistical Science, and Regulatory groups at DELFI
• Answer medical (protocol) questions directly from sites or from the site manager
• Answer specific inclusion/exclusion criteria questions
• Respond to safety questions and protocol deviations from the site or local IRB
• Attend, participate, and/or present investigator meetings
• Establish and maintain relationships with key academic and community-based clinical institutions, physician and clinical trial site investigators, and third party vendors, in furtherance of clinical evaluation of Delfi technologies
• Regularly organize and attend investigator meetings to enhance awareness and enrollment of studies evaluating DELFI technology
• Regularly engage expert advisors on matters of study design and endpoints
• Ensure execution of clinical trials in support of DELFI’s clinical evidence strategy
• Provide project team training on disease and/or therapeutic areas
• Supported the execution of pivotal clinical trials and research collaborations that support the development of the DELFI liquid biopsy approach for the non-invasive detection of cancer
• Supported the achievement of key product corporate goals at Delfi Diagnostics

Preferred Qualifications

• Industry experience within pharmaceutical or diagnostic medical device field
• Subspecialty training in Oncology, Pathology, Radiology, or Pulmonology