The Director will lead the DMPK and translational pharmacology strategy to optimize candidate selection and clinical translation across the company's pipeline. They will oversee nonclinical and clinical studies, manage external CROs, and ensure regulatory compliance for submissions like INDs and CTAs.
The Director of Clinical Science provides scientific and clinical leadership for Phase 1–3 clinical trials, overseeing protocol development, medical monitoring, and study execution. They also manage clinical pharmacology strategies, including dose selection and regulatory interactions to advance the company's development programs.
The Clinical Trial Manager leads the planning, execution, and oversight of complex Phase I-III clinical studies while managing budgets, timelines, and vendor performance. They ensure compliance with regulatory standards and facilitate cross-functional team alignment to achieve inspection readiness.
The Director of Clinical Supply Chain provides strategic and operational leadership for the end-to-end clinical supply chain, ensuring the availability of investigational products for global clinical trials. They manage cross-functional planning, vendor relationships, and supply chain systems to support clinical development programs while ensuring regulatory compliance.
The Senior CTA coordinates clinical trial activities from start-up to close-out, focusing on operational excellence and inspection readiness. Key duties include managing the Trial Master File (TMF), overseeing CROs and vendors, and supporting regulatory submissions.
