Associate Director, Program Safety Lead - Job ID: 1908b
Ascendis Pharma
August 15, 2026
Remote friendly (Palo Alto, CA)
United States
$200,000 - $215,000 USD yearly
Clinical Research and Development
The role of Program Safety Lead is a director level position reporting to the Head of Global Medical Safety Science. Serve as pharmacovigilance expert for the endocrinology pipeline, shaping strategy, setting priorities, and leading pharmacovigilance activities for assigned products. Steward product safety profile and drive safety-related decisions.
Responsibilities:
- Define safety strategy for assigned development and marketed products with cross-functional teams
- Serve as safety lead for assigned products; provide recommendations and oversight of 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 and safety input for expedited/aggregate safety reports (SUSARs, PSURs, DSURs, IND Annual Reports)
- Contribute to safety sections of labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions
- Collaborate on pharmacovigilance agreements, audits, and regulatory inspections
- Monitor 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
Qualifications:
- PharmD; proficient English (written and spoken)
- 6–8 years industry pharmacovigilance experience
- Leadership experience in product safety in a matrix organization
- Endocrinology Therapeutic Area experience
- Clinical medicine skills; at least 1 year clinical practice experience preferred
Skills/attributes:
- Passion for innovative therapies for rare endocrine diseases
- Balance strategic thinking with hands-on execution and mentoring
- Navigate uncertainty; adapt to changing priorities
Benefits (if offered): 401(k) match; medical/dental/vision; life/AD&D; short/long-term disability; pet/legal insurance; EAP; discounts; professional development; HSA; FSAs; incentive compensation plans; accident/critical illness/hospital indemnity; mental health resources; paid leave for new parents.
Responsibilities:
- Define safety strategy for assigned development and marketed products with cross-functional teams
- Serve as safety lead for assigned products; provide recommendations and oversight of 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 and safety input for expedited/aggregate safety reports (SUSARs, PSURs, DSURs, IND Annual Reports)
- Contribute to safety sections of labeling, investigator brochures, protocols, informed consent forms, and regulatory submissions
- Collaborate on pharmacovigilance agreements, audits, and regulatory inspections
- Monitor 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
Qualifications:
- PharmD; proficient English (written and spoken)
- 6–8 years industry pharmacovigilance experience
- Leadership experience in product safety in a matrix organization
- Endocrinology Therapeutic Area experience
- Clinical medicine skills; at least 1 year clinical practice experience preferred
Skills/attributes:
- Passion for innovative therapies for rare endocrine diseases
- Balance strategic thinking with hands-on execution and mentoring
- Navigate uncertainty; adapt to changing priorities
Benefits (if offered): 401(k) match; medical/dental/vision; life/AD&D; short/long-term disability; pet/legal insurance; EAP; discounts; professional development; HSA; FSAs; incentive compensation plans; accident/critical illness/hospital indemnity; mental health resources; paid leave for new parents.