Associate Director, Program Safety Lead - Job ID: 1908
Ascendis Pharma, Princeton, NJ, United States
Are you passionate about patient safety and ready to 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. Join us at Ascendis Pharma, where our core values—Patients, Science & Passion—drive us to deliver best‑in‑class therapies addressing critical unmet needs. The role
The Program Safety Lead is a director‑level position that reports to the Head of Global Medical Safety Science. You will serve as the pharmacovigilance expert for Ascendis’ endocrinology pipeline, shape strategy, set priorities, and lead pharmacovigilance activities for assigned products. As a key member of the Global Patient Safety Organization and cross‑functional product teams, you will steward the product safety profile and drive critical safety‑related decisions to support the Ascendis portfolio. 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, including 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 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 one year of clinical practice experience preferred As a person, you have/are:
A passion for advancing innovative therapies that address unmet medical needs for patients 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.
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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. Join us at Ascendis Pharma, where our core values—Patients, Science & Passion—drive us to deliver best‑in‑class therapies addressing critical unmet needs. The role
The Program Safety Lead is a director‑level position that reports to the Head of Global Medical Safety Science. You will serve as the pharmacovigilance expert for Ascendis’ endocrinology pipeline, shape strategy, set priorities, and lead pharmacovigilance activities for assigned products. As a key member of the Global Patient Safety Organization and cross‑functional product teams, you will steward the product safety profile and drive critical safety‑related decisions to support the Ascendis portfolio. 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, including 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 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 one year of clinical practice experience preferred As a person, you have/are:
A passion for advancing innovative therapies that address unmet medical needs for patients 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.
#J-18808-Ljbffr