3 дня назад
Senior Clinical Development Scientist (CAR-T)
153 935 - 199 210$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Development Scientist (CAR-T): Supporting late-stage oncology clinical development through trial design, study execution, data analysis, regulatory submissions, and clinical documentation with an accent on CAR-T therapies, clinical trial methodology, and GCP compliance. Focus on developing protocols and study materials, analyzing clinical data, addressing scientific and procedural issues, and coordinating cross-functional study activities.
Location: Parsippany, New Jersey, United States; travel may be required.
Salary: $153,935–$199,210 per year for other U.S. locations. Bay Area range: $169,320–$219,120 per year.
Company
Develops cancer immunotherapies, including CAR and T-cell receptor engineered cell therapies designed to help the immune system recognize and eliminate tumors.
What you will do
- Support late-stage oncology clinical development and ongoing clinical trial program activities.
- Develop study concept sheets, protocols, amendments, study manuals, investigator meeting materials, and related documentation.
- Contribute to clinical study start-up, execution, close-out, CRF design, data management manuals, and data analysis plans.
- Review clinical data listings, summary tables, study results, manuscripts, scientific presentations, and regulatory documents.
- Address scientific and procedural questions from investigators and help resolve moderately complex study obstacles.
- Coordinate teams, provide direction, and support clinical monitoring for assigned studies or study components.
Requirements
- PharmD or PhD in clinical research or clinical pharmacology with relevant scientific or drug development experience; alternatively, an MS with 6+ years or a BS/RN with 8+ years of relevant experience.
- Understanding of drug development phases and clinical trials across phases.
- Knowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practice, and standard clinical procedures.
- Analytical, communication, organizational, learning, flexibility, and adaptability skills.
- Ability to enter new therapeutic areas, summarize published scientific literature, and integrate findings into study development.
- Proficiency with Microsoft Office and other job-related programs.
Nice to have
- Experience in multiple myeloma and/or CAR-T therapy.
- Ability to coordinate teams and provide direction.
Culture & Benefits
- Full-time employment with a focus on inclusion, employee development, and team empowerment.
- Medical, dental, vision, and life insurance plans.
- Paid time off.
- Eligibility for a discretionary annual bonus and stock-based long-term incentives may apply.
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