- Location
- Palo Alto, California, United States · published
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Director
- Source
- Workable
Description
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 an associate 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 $200-215k 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.