1 день назад
Associate Director, Non-clinical Drug Safety (Biologics)
169 222 - 253 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Associate Director, Non-clinical Drug Safety (Biologics): Leading nonclinical safety strategies and GLP toxicology studies for small molecules and biologics with an accent on scientific assessment, regulatory submissions, and cross-functional development guidance. Focus on interpreting toxicology data, managing outsourced studies and program deliverables, and communicating risk-based recommendations to senior leadership.
Location: Remote within the United States
Salary: $169,222–$253,000 annually, plus incentive opportunity
Company
is a pharmaceutical company developing small-molecule and biologic medicines.
What you will do
- Lead nonclinical safety strategies for assigned small-molecule and biologic development programs.
- Serve as the toxicology subject matter expert on discovery and development teams.
- Lead and oversee IND- and NDA-enabling GLP toxicology studies.
- Analyze and integrate toxicology findings into nonclinical safety assessments and development strategies.
- Manage outsourced study activities, timelines, budgets, and deliverables.
- Communicate risk assessments to project teams and senior leadership and author or review regulatory documents.
Requirements
- MSc or PhD in Toxicology, Pharmacology, or a related field.
- At least 7 years of experience in a pharmaceutical company or contract research organization.
- Strong technical experience planning and executing nonclinical studies.
- Thorough knowledge of regulatory requirements and the overall drug development process.
- Ability to manage multiple programs, changing priorities, and detailed written and verbal communications.
Nice to have
- Experience with biologics.
- Regulatory expertise, including successful IND or CTA submissions.
- Diplomate of the American Board of Toxicology (DABT).
Culture & Benefits
- Full-time employment with flexible time off, paid holidays, and paid leave programs.
- Medical, dental, vision, prescription drug, life, and disability insurance.
- Generous 401(k) match.
- Tuition reimbursement and student loan assistance.
- Collaborative, cross-functional work focused on scientific standards, continuous improvement, and evolving regulatory guidance.
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