Associate Director, Program Safety Lead (MD) - 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 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.

• 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

You hold a Medical Doctoral degree (or equivalent) – and are proficient in English at a professional level, both written and spoken.

• 6-8 years, of industry pharmacovigilance experience in a fast-paced biopharmaceutical company. 
• Leadership experience within the safety profile of products assigned within a matrix organization
• Endocrinology Therapeutic Area experience
• Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience is preferred

• A passion for advancing innovative therapies that address unmet medical needs for patients struggling with Rare Endocrine Diseases
• Comfortable balancing strategic thinking with hands-on execution and mentoring
• Demonstrated ability to navigate uncertainty and adapt quickly to changing priorities
• Proven track record delivering results in dynamic, fast-paced settings where clarity evolves over time