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3 дня назад

Senior Clinical Development Scientist (CAR-T)

153 935 - 199 210$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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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