Medical Director/Senior Medical Director, Clinical Development (Remote)

The Medical/Senior Medical Director will play a key role on cross-functional teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted for the clinical development programs. The successful candidate will have direct medical responsibility for creating clinical development plans, designing clinical studies, writing protocols, providing CRO oversight and safety monitoring of clinical programs. The Medical Director will contribute collaboratively toward the clinical aspects of research and early-stage development programs, providing insight into treatment indications, patient populations, study designs and overall development strategies.The Medical Director, Clinical Development will report to Chief Medical Officer and is responsible for supporting clinical development, functioning as the medical lead and medical monitor for clinical trials, and working with cross-functional multidisciplinary study teams on clinical trial strategy, design, and execution. The ideal candidate will have experience as a medical monitor in early- to late-stage clinical trials.Ideal candidate would be based remote in eastern time zone. Responsibilities:Contribute to the development and execution of comprehensive clinical development plans for Glycomines’s development programs. Offer expert clinical advice, drawing on extensive clinical knowledge. Will review clinical study data and prepare reports, protocols, and development plans. Collaborate with early development research teams on clinical aspects and disease indicationsServe as a medical expert in the company, staying current with the latest research and medical advancements in the fields being studiedContribute to the design and oversight of clinical trials, develop study protocols, case report forms, and informed consent documents, ensuring they are conducted in compliance with regulatory standards and ethical guidelinesCollaborate with the regulatory team to prepare and submit regulatory documents to health authorities, including INDs, NDAs, and BLAs. Collaborate with study team to prepare and complete clinical study reports, investigator’s brochures and Data Safety Update Reports.Contribute to the Board meeting preparation including the Board of Directors, Data Safety Monitoring Board and  Clinical Advisory Board.Provide medical oversight for current and future clinical trials, including safety monitoring, data analysis, and interpretation of clinical trial resultsBuild and maintain strong relationships with key opinion leaders (KOLs) and academic institutions to support the company's scientific and clinical objectivesCollaborate closely with other departments such as clinical operations, technical operations/CMC, translational research and regulatory affairs to ensure alignment on program objectivesLead the development of scientific publications, presentations, and educational materials related to Glycomine’s programsProvide medical, disease-specific, and development perspective into specific research programs or broader research initiativesSupport start-up activities (informed consent forms, eCRF design, etc.) related to the assigned clinical studiesServe as primary medical point of contact for sites and PIs for the assigned studies, as applicableInterface with international regulatory authorities, as appropriate, in support of the development objectives for the compound or program