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

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.

Requirements: Your professional qualifications You have a PharmD degree– and are proficient in English at a professional level, both written and spoken. Furthermore, you have: 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 As a person, you have/are: 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 Travel: Ability to travel up to 20% of the time domestically and internationally Office location: This is a hybrid role operating preferably out of Palo Alto, CA; however, we welcome candidates to apply residing near our Princeton, NJ office.

Type: full time