Associate Director, Program Safety Lead - Job ID: 1908

Are you passionate about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Program Safety Lead to champion safety excellence, drive compliance, and shape strategy across our growing portfolio.

We are a dynamic, global biopharmaceutical company headquartered in Denmark with hubs in Palo Alto, CA and Princeton, NJ.  Come join us at Ascendis Pharma, where our core values --- Patients, Science & Passion, drive us to deliver best-in-class therapies that address critical unmet needs.

The role

The role of Program Safety Lead is a director level position here at Ascendis and this Lead will report to the Head of Global Medical Safety Science. You will play a pivotal role as the Program Safety Lead and pharmacovigilance expert for the Ascendis’ endocrinology pipeline.  As a key member of the Global Patient Safety Organization and cross-functional product teams, you will shape the strategy, set priorities and lead pharmacovigilance activities for assigned products.  The Program Safety Lead stewards the product safety profile and drives critical safety-related decisions to support the Ascendis portfolio.   

As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.

You will:

• Define safety strategy for assigned development and marketed products in collaboration with cross-functional teams
• Serve as the safety lead for assigned products, providing 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 (e.g., 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

The estimated salary range for this position is $220-245 DOE.  Actual salary determination is dependent on a variety of factors some of which include: experience, qualifications, and geographic location.  This position may be eligible for a discretionary annual bonus or an incentive compensation plan (eligibility varies based on role and position level), discretionary stock-based long-term incentives, paid time off, and a comprehensive benefits package.