The Senior Manager will lead and manage supporting studies for the PH-ILD program, ensuring deliverables are met on time and within budget. They will serve as a key point of contact for cross-functional teams and integrate project management tools to streamline program execution.
Lead statistical programming for clinical studies and regulatory submissions, producing and validating CDISC-compliant datasets, tables, listings, figures, and submission documentation. Coordinate with cross-functional teams and external vendors, manage programming timelines and quality, and contribute to standards, process improvements, and mentoring.
The Senior Manager will oversee global clinical supply chain activities, including packaging, labeling, and distribution to support clinical trials. They will act as the subject matter expert for drug supply, managing inventory, vendor performance, and system implementation.
The Senior Director of Regulatory Affairs will lead global regulatory strategy and manage submissions for clinical trials and product registrations. They will serve as the primary regulatory contact for health authorities and cross-functional project teams to ensure compliance and project success.
The Associate Director will lead late-stage drug substance development, process design, and technical transfer across an external CDMO network. They are responsible for ensuring regulatory compliance, managing scale-up activities, and overseeing commercial readiness for the company's pipeline.
The Director of Biostatistics will serve as the lead for the Phase 3 PHrontier program, overseeing trial design, statistical strategy, and regulatory submissions. They will partner with clinical and regulatory teams while managing CRO deliverables and mentoring junior staff.
Oversee clinical-trial safety surveillance, serious adverse event case processing, signal assessment, aggregate safety reporting, and compliance with global pharmacovigilance requirements. Manage PV vendors and CROs, support safety committees and health authority interactions, maintain safety documentation and quality processes, and guide the growing pharmacovigilance function.
The Clinical Development Lead will oversee the design and execution of clinical trials for mosliciguat, ensuring medical accountability and regulatory compliance. They will collaborate with cross-functional teams, investigators, and key opinion leaders to drive high-quality clinical data and strategic program development.
The Director of Clinical Supply will oversee global clinical supply chain activities, including packaging, labeling, and distribution for investigational medicinal products. They will manage vendor relationships, ensure regulatory compliance, and lead clinical supply managers to support clinical trial objectives.
The Associate Director of Regulatory Affairs will develop and execute global regulatory strategies while serving as a key liaison between the company and health authorities. They are responsible for planning, authoring, and managing regulatory submissions to ensure compliance throughout the clinical development and registration process.
