Associate Director, Program Safety Lead - Job ID: 1908

ascendis pharma

Pharmazeutische Industrie

Princeton, NJ - USA

Abteilungsleiter / Manager

Experteer Overview

In this director-level role, you will lead pharmacovigilance strategy for Ascendis’ endocrinology portfolio and oversee safety activities across development and marketed products. You will collaborate with cross-functional teams to shape safety priorities, ensure global regulatory compliance, and steward critical safety decisions. You’ll contribute to risk management, safety reporting, and regulatory submissions, acting as a patient-safety advisor within Clinical Development, Medical Affairs, and PV teams. This is a chance to drive safety excellence in a fast-growing global organization.

Leistungen / Benefits

$220-245 DOE salary
discretionary annual bonus
stock-based long-term incentives
paid time off
comprehensive benefits package

Verantwortungsbereiche

Define safety strategy for development and marketed products in collaboration with cross-functional teams
Serve as the safety lead for assigned products with strategic recommendations and oversight of patient safety activities
Ensure compliance with global pharmacovigilance regulations including signal detection, evaluation, and risk management
Develop and maintain safety surveillance and risk management plans for drug development programs
Oversee identification and evaluation of safety signals and ensure timely escalation and resolution
Provide medical and safety input for expedited and aggregate safety reports (SUSARs, PSURs, DSURs, IND Annual Reports)
Contribute to safety sections of labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions
Collaborate with internal and external stakeholders on pharmacovigilance agreements, audits, and regulatory inspections
Monitor industry best practices and evolving global safety regulations; recommend updates to policies and SOPs
Act as a patient safety advisor across Clinical Development, Medical Affairs, Commercial, and PV teams

Stellenbeschreibung

In this director-level role, you will lead pharmacovigilance strategy for Ascendis’ endocrinology portfolio and oversee safety activities ac…

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