Associate Medical Director/Medical Director

About the role

Iambic Therapeutics is seeking an Associate Medical Director or Medical Director to join its growing Clinical Development team. This position will be responsible for study execution and oversight of a clinical program currently in phase 1, as well as supporting pipeline programs that are in the preparation phase for IND submission. In addition to providing medical oversight for the phase 1 clinical trial, ensuring patient safety, regulatory compliance and scientific integrity, this individual will also contribute to the clinical program strategy and execution.

Responsibilities

• Serve as the medical monitor for assigned clinical trials, providing medical and scientific expertise throughout the study lifecycle.
• Work closely with other functional areas within Research and Development (clinical operations, regulatory sciences, data management, biostatistics, clinical pharmacology, nonclinical) to facilitate the execution of clinical trials and ensure that high standards of study conduct are met
• Ensure participant safety by reviewing adverse events (AEs), serious adverse events (SAEs) and protocol deviations collaborate with pharmacovigilance to assess safety signals across the study
• Provide guidance on patient eligibility and protocol adherence
• Contribute to preparation of study-related documents including study protocols and amendments, Investigator Brochures (IBs), informed consent forms (ICFs), and clinical study reports (CSRs)
• Review and interpret clinical trial data, ensuring accuracy and consistency in the safety, efficacy and other data
• Support interactions with regulatory agencies, including preparation of documents for submission and participation at regulatory meetings
• Establish strategic