Associate Director, Program Safety Lead - Job ID: 1908b

Ascendis Pharma•Palo Alto, CA

20d•Hybrid

About The Position

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. 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.

Requirements

PharmD degree
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
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
Ability to travel up to 20% of the time domestically and internationally

Responsibilities

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