Cullinan Therapeutics Inc

Medical Director/Senior Medical Director, Clinical Development

United States

Medical Director/Senior Medical Director, Clinical Development United States Position Responsibilities Key responsibilities of the role may include, but are not limited to: - Serves as the medical monitor for clinical trials and assists in resolving major issues that may affect their assigned studies. - Partners with the Clinical Scientist, Data Manager, Pharmacovigilance Scientist, and other members of the study team to conduct the clinical studies, including study design, operational feasibility assessment, and site selection. - Provides expert opinion and review for creation of key study documents, including clinical study protocols, safety and medical monitoring plans, charters, and informed consent forms. - Interacts closely with Regulatory Affairs to contribute or review clinically relevant components of investigator brochures, briefing books, and other regulatory documents and communications. - Working with other members of the clinical study team, conducts investigator meetings, leads site initiation visits, and maintains relationships with clinical trial investigators. - Works with internal discovery and translational scientists, technical operations/manufacturing teams, regulatory affairs, safety and pharmacovigilance, and external consultants or CROs in a cross-functional manner. - Working closely with the Clinical Research Scientist and other members of the clinical study team (data management, biostatistics, and others), oversees and supports the gathering, analyzing, reviewing, interpreting, and reporting of clinical safety and efficacy data. - Supports publication and external communication strategy, acting as owner of clinical data, collaborating in the creation of meeting abstracts, presentations, and publications, and presenting at investigator meetings and scientific conferences as required. Candidate Qualifications Required: - MD, DO, or