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 $200-215k 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 have a PharmD degree– and are proficient in English at a professional level, both written and spoken.
Furthermore, you have:
- 6-8 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 preferably out of Palo Alto, CA; however, we welcome candidates to apply residing near our Princeton, NJ office.
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.
Skills Required
- PharmD degree
- Professional-level English (written and spoken)
- 6-8 years industry pharmacovigilance experience in biopharmaceutical companies
- Leadership experience managing product safety profiles within a matrix organization
- Endocrinology therapeutic area experience
- Experience with signal detection, evaluation, and risk management
- Experience preparing or providing input for expedited and aggregate safety reports (SUSARs, PSURs, DSURs, IND Annual Reports)
- Experience with safety surveillance and developing risk management plans
- Experience collaborating on pharmacovigilance agreements, audits, and regulatory inspections
- Ability to travel up to 20% domestically and internationally
- Demonstrated clinical medicine skills; at least 1 year clinical practice experience
What We Do
Ascendis Pharma is applying its innovative TransCon technologies to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company utilizes its TransCon technologies to create new and potentially best-in-class therapies. Ascendis Pharma currently has a pipeline of three independent endocrinology rare disease product candidates and one oncology product candidate in clinical development. The company continues to expand into additional therapeutic areas to address unmet patient needs. Ascendis is headquartered in Copenhagen, Denmark, with additional offices in Heidelberg and Berlin, Germany, Palo Alto and Redwood City, California, and Princeton, New Jersey.
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