• Bring medical and scientific expertise to the design, execution, and interpretation of FIH, Phase 1, and Phase 2 clinical studies ensuring patient safety and scientific integrity • Author and oversee key clinical documents — including protocols, amendments, informed consent forms, investigator brochures, clinical study reports, and regulatory submissions (e.g., INDs, CTAs, DSURs). Respond to health authority and IRB inquiries for respective studies • Review, analyze, and interpret emerging clinical data (safety, efficacy, PK/PD) to identify trends and issues, ensuring timely resolution through cross-functional collaboration • Provide ongoing data review to ensure study conduct aligns with protocol, patient safety standards, and data integrity expectations. Collaborate with Pharmacovigilance to ensure awareness of key safety and efficacy findings, supporting SAE review, narrative development, and safety governance activities • Contribute to and present scientific and clinical data internally and externally (e.g., investigator meetings, scientific conferences, manuscripts, regulatory interactions) • Contribute to vendor oversight to ensure consistency, quality, and scientific rigor across all clinical deliverables. Interact with investigators as needed, assist in site selection, and support training of sites at study start-up