Program Safety Lead

Title: Program Safety Lead, GPS Medical Science - Job ID: 1692

Location: Palo Alto, CA and Princeton, NJ US

Type: Full-time

Workplace: Hybrid remote

Job Description:

Are you passionate about patient safety and ready to help lead a fast-paced, global pharmacovigilance organization? Ascendis Pharma is seeking an experienced Product 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 Product 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 Product 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 Product 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 $240-260k.  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 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:

• 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 either Princeton, NJ or Palo Alto, CA

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

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
• 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.