Associate Director, Program Safety Lead (MD) - Job ID: 1908

Job Summary

The Program Safety Lead at Ascendis Pharma is responsible for defining safety strategy, ensuring compliance with global pharmacovigilance regulations, and driving critical safety-related decisions for assigned products. Reporting to the Head of Global Medical Safety Science, this role plays a pivotal role in shaping the safety profile of the Ascendis' endocrinology pipeline.

Key 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

Qualifications

• Hold a Medical Doctoral degree (or equivalent) and proficiency in English at a professional level
• 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

Requirements

• 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
• Proven track record delivering results in dynamic, fast-paced settings where clarity evolves over time
• Ability to navigate uncertainty and adapt quickly to changing priorities

Benefits

• 401(k) plan with company match
• Medical, dental, and vision plans
• Company-offered Life and Accidental Death & Dismemberment (AD&D) insurance
• Company-provided short and long-term disability benefits
• Unique offerings of Pet Insurance and Legal Insurance
• Employee Assistance Program
• Employee Discounts
• Professional Development Health Saving Account (HSA)
• Flexible Spending Accounts
• Variety of incentive compensation plans
• Accident, Critical Illness, and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits for new parents