Associate Director, Program Safety Lead
Ascendis Pharma
full-time
Posted on:
Location Type: Hybrid
Location: Princeton • New Jersey • United States
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Salary
💰 $220,000 - $245,000 per year
Job Level
About the role
- 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
Requirements
- 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.
- 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
- 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
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancesafety surveillancerisk managementsignal detectionclinical medicinesafety reportingregulatory submissionssafety strategysafety signals evaluationdrug development
Soft Skills
leadershipstrategic thinkingmentoringadaptabilitycommunicationcollaborationproblem-solvingresults-orientedinterpersonal skillsexecution
Certifications
Doctoral degreeMDPhDPharmD