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Protocol and Study Design: Author or guide clinical study protocols, amendments, IBs, and SAP inputs; ensure endpoints, eligibility, assessments, and operationalization are scientifically sound and feasible Medical Oversight of Trials: Provide medical monitoring, review eligibility, safety events, and dose modifications; chair study medical reviews; establish proactive risk mitigation to safeguard patients while maintaining study integrity. Data Interpretation and Reporting: Lead clinical data review, benefit-risk assessment, and interpretation; contribute to CSRs, manuscripts, abstracts, and scientific presentations; support transparent data disclosure in accordance with policies to elevate program credibility. Regulatory Interactions: Contribute to regulatory strategy and author medical sections of IND/CTA, briefing books, and NDA/BLA/MAA; represent the program in health authority meetings (e.g., FDA, EMA, PMDA) Safety and Pharmacovigilance: Partner with drug safety to monitor the safety profile, support signal detection and management, and contribute to RMPs, DSURs, and aggregate reports Cross-Functional Collaboration: Work closely with clinical operations, biostatistics, translational medicine, regulatory affairs, CMC, commercial, and market access to build integrated plans milestone delivery External Engagement: Build relationships with key opinion leaders, investigators, and consortia; contribute to advisory boards; support site engagement and feasibility Evidence Generation and Publications: Build publication plans, ensure scientific rigor, and communicate results at congresses and in peer-reviewed journals Ethics and Compliance: Uphold Good Clinical Practice (GCP), ICH, local regulations, and company SOPs; ensure ethical conduct and patient-centric decision-making Essential Skills/Experience: MD or DO (or equivalent) Significant experience as a physician Extensive general medical knowledge Extensive experience in managing or designing clinical trials which require close monitoring Desirable Skills/Experience: Board certification in a relevant specialty preferred The annual base pay for this position ranges from $241,613,60 to $362,420.40. 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