Associate Director, Program Safety Lead - Job ID: 1908
Ascendis Pharma
June 30, 2026
Remote friendly (Princeton, NJ)
United States
$220,000 - $235,000 USD yearly
Clinical Research and Development
The Program Safety Lead is a director-level position reporting to the Head of Global Medical Safety Science. This role serves as pharmacovigilance expert for the endocrinology pipeline and leads product safety strategy, priorities, and pharmacovigilance activities for assigned products.
Responsibilities:
- Define safety strategy for assigned development and marketed products in collaboration with cross-functional teams
- Serve as safety lead for assigned products; provide strategic recommendations and oversee patient safety activities
- Ensure compliance with global pharmacovigilance regulations (signal detection, evaluation, risk management)
- Develop and maintain safety surveillance and risk management plans
- Oversee identification and evaluation of safety signals; ensure timely escalation and resolution
- Provide medical/safety input for expedited and aggregate safety reports (SUSARs, PSURs, DSURs, IND Annual Reports)
- Contribute safety content to labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions
- Collaborate with internal/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 patient safety advisor across Clinical Development, Medical Affairs, Commercial, and PV teams
Requirements:
- Doctoral degree (preferably MD or equivalent, PhD, or PharmD) and professional English proficiency
- Minimum 8 years (preferably 10) industry pharmacovigilance experience in a biopharmaceutical company
- Leadership experience in product safety within a matrix organization
- Endocrinology Therapeutic Area experience
- Clinical medicine skills; at least 1 year clinical practice experience preferred
Preferred/Personal:
- Passion for therapies for patients with Rare Endocrine Diseases
- Ability to balance strategic thinking with hands-on execution and mentoring
- Adaptable in changing priorities
Travel: up to 20%.
Office: hybrid, Princeton, NJ.
Apply as soon as possible; evaluations begin when received.
Benefits (as stated): 401(k) match; medical/dental/vision; Life/AD&D; short/long-term disability; pet/legal insurance; EAP; employee discounts; professional development; HSA/FSA; incentive plans; accident/critical illness/hospital indemnity; mental health resources; paid parental leave.
Responsibilities:
- Define safety strategy for assigned development and marketed products in collaboration with cross-functional teams
- Serve as safety lead for assigned products; provide strategic recommendations and oversee patient safety activities
- Ensure compliance with global pharmacovigilance regulations (signal detection, evaluation, risk management)
- Develop and maintain safety surveillance and risk management plans
- Oversee identification and evaluation of safety signals; ensure timely escalation and resolution
- Provide medical/safety input for expedited and aggregate safety reports (SUSARs, PSURs, DSURs, IND Annual Reports)
- Contribute safety content to labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions
- Collaborate with internal/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 patient safety advisor across Clinical Development, Medical Affairs, Commercial, and PV teams
Requirements:
- Doctoral degree (preferably MD or equivalent, PhD, or PharmD) and professional English proficiency
- Minimum 8 years (preferably 10) industry pharmacovigilance experience in a biopharmaceutical company
- Leadership experience in product safety within a matrix organization
- Endocrinology Therapeutic Area experience
- Clinical medicine skills; at least 1 year clinical practice experience preferred
Preferred/Personal:
- Passion for therapies for patients with Rare Endocrine Diseases
- Ability to balance strategic thinking with hands-on execution and mentoring
- Adaptable in changing priorities
Travel: up to 20%.
Office: hybrid, Princeton, NJ.
Apply as soon as possible; evaluations begin when received.
Benefits (as stated): 401(k) match; medical/dental/vision; Life/AD&D; short/long-term disability; pet/legal insurance; EAP; employee discounts; professional development; HSA/FSA; incentive plans; accident/critical illness/hospital indemnity; mental health resources; paid parental leave.