General Summary Serve as the Medical Lead for clinical trials, working with cross‑functional teams on trial strategy, design, execution, and reporting. Provide oversight and accountability for the study, serving as the internal primary Medical Monitor responsible for monitoring the safety of enrolled subjects and ensuring scientific integrity. May participate in other projects to support the clinical development program. Key Duties And Responsibilities Participate in development of Study Protocols, Investigator’s Brochures, Clinical Development Plans, and other key documents with minimal guidance. Serve on cross‑functional Study Execution Teams (SET) for assigned trials to support efficient, high‑quality execution. Prepare regulatory documents for submissions, including clinical sections of INDs/CTAs, IND safety reports and annual reports; respond to regulatory authorities and Ethics Committees/IRBs. Provide scientific/clinical input to study documents and analysis plans (e.g., informed consent forms, research forms, statistical analysis plans, clinical pharmacology analysis plans, clinical study reports). Liaise between Clinical Development and internal groups (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies. Represent the company to outside medical personnel regarding protocols, study conduct, and external reporting of results. Knowledge And Skills Strong oral and written communication; collaborative in a fast‑paced matrix environment; ability to work independently. Global clinical research experience and regulatory authority interaction (plus). Familiarity with research data analysis, biostatistics, pharmacology/pharmacokinetics, GCP, clinical study design, ethics committee/IRB review, manuscript/abstract/poster/oral presentation preparation, and drug/device clinical development. Board certification/eligibility and clinical training in a relevant medical specialty (highly desired). Education And Experience MD, DO, or equivalent ex‑US medical degree. Typically 8 years of basic or clinical research experience in academic or industry settings (or equivalent education/experience). #J-18808-Ljbffr