Associate Director, Program Safety Lead Job ID 1908

Are you passionate about patient safety and ready to help lead a fast-paced global pharmacovigilance organization 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. Come join us at Ascendis Pharma where our core values --- Patients Science & Passion drive us to deliver best-in-class therapies that address critical unmet needs.

The role

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.

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 $220-245 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.

Your professional qualifications

You hold a Doctoral degree -- preferably an MD (or equivalent) PhD PharmD and are proficient in English at a professional level both written and spoken.

Furthermore you have:

• Minimum of eight years preferably ten 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 out of Princeton NJ

Applications will be evaluated when received so please apply as soon as possible.

• 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
• Various incentive compensation plans
• Accident Critical Illness and Hospital Indemnity Insurance
• Mental Health resources
• Paid leave benefits for new parents

A note to recruiters:

We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged.

Required Experience:

Director