# Associate Director, Program Safety Lead - Job ID: 1908

**Company:** [Ascendis Pharma](http://jobs.workable.com/companies/8hdDoWwXy86xHuuLSJuWva.md)
**Location:** Princeton, United States
**Workplace:** hybrid
**Employment type:** Full-time
**Department:** Global Patient Safety Operations

[Apply for this job](http://jobs.workable.com/view/dd382b14-816c-4725-b2df-c7f864db9e23)

## Description

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 $220-235 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.

## 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:**

-   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.

## 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.**
