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Salary: USD 220,000 - 235,000 / annual
Ascendis Pharma, a global biopharmaceutical company headquartered in Denmark with major hubs in Palo Alto, CA and Princeton, NJ, is seeking an experienced Associate Director, Program Safety Lead to champion safety excellence and drive compliance across its growing endocrinology portfolio.
Reporting to the Head of Global Medical Safety Science, you will serve as the pharmacovigilance expert and safety steward for assigned development and marketed products. This is a director-level position within the Global Patient Safety Organization, where you will shape safety strategy, set priorities, and lead pharmacovigilance activities for the endocrinology pipeline in collaboration with cross-functional product teams.
Key responsibilities include: defining safety strategy for assigned products in collaboration with clinical, medical affairs, and commercial teams; serving as the primary safety lead providing strategic recommendations and oversight of patient safety activities; ensuring compliance with global pharmacovigilance regulations including signal detection, evaluation, and risk management; developing and maintaining safety surveillance and risk management plans; overseeing identification and evaluation of safety signals with timely escalation; providing medical and safety input for expedited and aggregate safety reports (SUSARs, PSURs, DSURs, IND Annual Reports); contributing to safety sections of labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions; collaborating with internal and external stakeholders on pharmacovigilance agreements, audits, and regulatory inspections; monitoring industry best practices and evolving global safety regulations; and acting as a patient safety advisor across Clinical Development, Medical Affairs, Commercial, and PV teams.
You hold a Medical Doctoral degree (MD, DO, or equivalent) and are proficient in English at a professional level. You bring 6–8 years of industry pharmacovigilance experience in a fast-paced biopharmaceutical company, with demonstrated leadership experience managing the safety profile of assigned products in a matrix organization. Endocrinology therapeutic area experience is required. Clinical medicine experience with at least 1 year of clinical practice is preferred.
As a person, you are passionate about advancing innovative therapies for rare endocrine diseases, comfortable balancing strategic thinking with hands-on execution and mentoring, able to navigate uncertainty and adapt quickly to changing priorities, and have a proven track record delivering results in dynamic, fast-paced settings. You are willing to travel up to 20% of the time domestically and internationally.
This is a hybrid role operating preferably out of Palo Alto, CA, though candidates near the Princeton, NJ office are also welcome.
