Associate Director, Program Safety Lead

About the role

Ascendis Pharma, a global biopharmaceutical company with hubs in Palo Alto, CA and Princeton, NJ, is looking for an Associate Director, Program Safety Lead to act as its pharmacovigilance expert for the endocrinology pipeline. Reporting to the Head of Global Medical Safety Science, the Lead shapes strategy, sets priorities and leads pharmacovigilance activities for assigned products within the Global Patient Safety Organization and cross-functional product teams.

Key responsibilities

• Define safety strategy for assigned development and marketed products with cross-functional teams and oversee 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 their timely escalation and resolution.
• Provide input for expedited and aggregate safety reports such as SUSARs, PSURs, DSURs and IND Annual Reports.
• Contribute to safety sections of labeling, investigator brochures, protocols, informed consent forms and regulatory submissions.
• Collaborate on pharmacovigilance agreements, audits and regulatory inspections, and recommend policy and SOP updates.
• Act as a patient safety advisor across Clinical Development, Medical Affairs, Commercial and PV teams.

Required profile

• PharmD degree and professional-level English, written and spoken.
• 6-8 years of industry pharmacovigilance experience in a fast-paced biopharmaceutical company.
• Leadership experience within a matrix organization and endocrinology therapeutic area experience.
• At least 1 year of clinical practice experience preferred.
• Ability to travel up to 20% domestically and internationally; hybrid role, preferably based in Palo Alto, CA.

What we offer

• Estimated salary of $200-215k DOE, with possible discretionary bonus, stock-based long-term incentives and paid time off.
• 401(k) with company match, medical, dental and vision plans, life and AD&D insurance, disability benefits, HSA and flexible spending accounts.
• Pet and legal insurance, employee assistance program, professional development, mental health resources and paid leave for new parents.