2 дня назад
Director, Patient Safety (MD) (CAR-T)
221 000 - 286 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Director, Patient Safety (MD) (CAR-T): Leading patient-safety strategy for CAR-T clinical development programs and postmarketing activities with an accent on signal detection, benefit-risk assessment, and regulatory compliance. Focus on authoring safety documentation, leading SRC and DSMB reviews, shaping risk-management strategies, and applying real-world evidence and advanced analytics.
Location: United States — New Jersey — Parsippany
Salary: $221,000–$286,000 per year, with potential annual bonus, stock-based long-term incentives, paid time off, and benefits.
Company
is a biopharmaceutical company developing CAR and T-cell receptor engineered cancer immunotherapies.
What you will do
- Lead safety signal detection, evaluation, and benefit-risk assessments across clinical trials and postmarketing settings.
- Own safety strategy, patient risk-management activities, and safety communications for assigned products.
- Author safety sections for protocols, Investigator’s Brochures, CSRs, DSURs, RMPs, and regulatory responses.
- Represent Drug Safety on global development and product teams and lead SRC and DSMB meetings.
- Collaborate with Clinical Research, Regulatory, Biostatistics, Medical Affairs, Pharmacovigilance, and external partners.
- Drive safety-science innovation, process improvements, inspection readiness, and safety-operations planning while mentoring junior scientists.
Requirements
- MD required; residency or subspecialty fellowship preferred.
- At least 5 years of drug safety or pharmacovigilance experience focused on clinical trials and cross-functional collaboration.
- Experience with cell or gene therapy, immunotherapies, or inflammation therapies.
- Clinical experience in oncology, rheumatology, or neurology is strongly preferred.
- Knowledge of global regulatory requirements, including FDA, EMA, and ICH.
- Experience with safety databases and signal-detection tools such as ARISg, Argus, Empirica, or Spotfire.
Culture & Benefits
- People-leadership responsibilities include creating inclusion, developing talent, and empowering teams.
- Medical, dental, vision, and life insurance plans are available to eligible employees.
- Paid time off and potential discretionary bonus and stock-based long-term incentives are offered.
- Focus on scientific rigor, collaboration, employee development, and an inclusive work environment.
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