Jobs at Ascendis Pharma

Lead pharmacovigilance strategy and safety activities for assigned endocrinology products. Oversee signal detection, risk management, safety reporting, labeling input, regulatory submissions, audits/inspections, and cross-functional collaboration to ensure global compliance and patient safety across development and marketed programs.

Lead pharmacovigilance strategy and execution for assigned endocrinology products, ensuring regulatory compliance, signal detection, risk management, safety reporting, and cross-functional safety oversight across development and marketed programs.

Designs, oversees, and analyzes late-phase clinical trials in endocrinology and oncology. Produces and reviews clinical protocols, reports, regulatory documents, and site materials. Monitors safety and efficacy data, supports site and subject retention, collaborates cross-functionally, advises investigators and KOLs, and contributes to regulatory submissions and scientific communications. Travels up to 20% for meetings.

Lead statistical programming for clinical trials from study start through regulatory submission. Develop and validate SDTM/ADaM datasets, generate and validate TLFs, create reusable macros and specification templates, support statisticians with analyses, and represent programming in cross-functional study teams while ensuring timelines, quality, and adherence to SOPs and regulatory standards.

Manage ICSR processing and workflow ensuring timely reporting and database integrity per ICH-GCP, GVP, FDA/EU regulations. Oversee and quality-check vendor-processed ICSRs, triage adverse events, support CTV/SAE reconciliation, update SOPs and training, liaise cross-functionally, and drive process improvements. Hybrid role based in Palo Alto with up to 20% travel.