обновлено 3 дня назад
Sr. Scientist, Toxicology (Cell And Gene Therapy)
127 313 - 167 099$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Sr. Scientist, Toxicology (Cell And Gene Therapy): Supporting nonclinical development and safety assessment for cell and gene therapy programs with an accent on toxicology, pharmacology, biodistribution, pharmacokinetics, and regulatory submissions. Focus on designing and interpreting complex safety studies, assessing risks such as immunogenicity and off-target effects, and preparing IND-enabling and health authority materials.
Location: Hybrid role based in Philadelphia, Pennsylvania, or Somerset, New Jersey, United States
Salary: $127,313–$167,099 USD base pay annually, plus performance-based bonus and/or equity for eligible employees.
Company
is a biotechnology company developing cell and gene therapies, including CAR-T, TCR-T, and natural killer cell-based therapies for serious diseases.
What you will do
- Support toxicology activities across discovery and development-stage cell and gene therapy programs.
- Design, monitor, interpret, and report nonclinical safety, pharmacology, biodistribution, and pharmacokinetic studies.
- Integrate toxicology and pharmacology data to support candidate selection, risk assessment, and program progression.
- Manage CRO study activities, including protocol review, monitoring, data interpretation, and final report review.
- Collaborate with Pharmacology, CMC, Clinical, Regulatory Affairs, and Program Management teams.
- Prepare briefing packages, pre-IND and IND submissions, investigator brochures, and responses to health authority questions.
Requirements
- Ph.D., DVM, PharmD, or equivalent degree in Toxicology, Pharmacology, Immunology, or a related discipline.
- At least 5 years of experience in nonclinical toxicology or a related field within biotechnology or pharmaceutical R&D.
- Working knowledge of GLP toxicology, nonclinical pharmacology studies, CRO management, and regulatory expectations.
- Understanding of FDA, EMA, and ICH regulations related to toxicology and cell and gene therapy development.
- Scientific writing, communication, presentation skills, and the ability to work independently in a collaborative matrixed environment.
- Applicants must be authorized to work in the United States; employment eligibility is verified through Form I-9 and E-Verify.
Nice to have
- Experience with cell therapy, gene therapy, biologics, or other advanced therapeutic platforms.
- Experience contributing to IND/CTA-enabling packages and global regulatory submissions.
Culture & Benefits
- Hybrid work environment within a global biotechnology organization.
- Medical, dental, and vision insurance.
- 401(k) retirement plan with a company match that fully vests on day one.
- Eight weeks of paid parental leave after three months of employment.
- Paid vacation, personal and sick time, floating holidays, and eleven company holidays.
- Additional benefits include flexible spending and health savings accounts, disability coverage, commuter benefits, family care resources, and well-being initiatives.
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