Program Safety Lead, GPS Medical Science - Job ID: 1908

Ascendis Pharma•Princeton, NJ

3d•$220 - $245•Hybrid

About The Position

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.

Requirements

Doctoral degree -- preferably an MD (or equivalent), PhD, PharmD
Proficient in English at a professional level, both written and spoken
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
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
Ability to travel up to 20% of the time domestically and internationally

Nice To Haves

Demonstrated skills in clinical medicine with at least 1 year of clinical practice experience is preferred

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