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3 дня назад

Director, Clinical Development/Clinical Scientist (Oncology)

209 500 - 271 000$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
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
Director, Clinical Development/Clinical Scientist (Oncology): Leading clinical development strategy and execution for oncology programs, including study design, clinical trial conduct, regulatory documentation, data interpretation, and cross-functional collaboration with internal and external partners, with an accent on global drug development, clinical oncology, and compliant study execution. Focus on developing clinical plans, monitoring patient eligibility and safety questions, analyzing clinical data, preparing regulatory materials, and building investigator and opinion-leader networks.

Location: Woburn, Massachusetts, United States; on-site. Work-related travel of approximately 25% is expected.

Base salary: $209,500–$271,000 per year, plus potential performance incentive bonus, equity, and benefits.

Company

hirify.global is a biotechnology company developing oncolytic immunotherapies based on its RPx platform to activate systemic anti-tumor immune responses and transform cancer treatment.

What you will do

  • Lead clinical development strategy and contribute to clinical development plans and program strategy.
  • Design, implement, conduct, analyze, interpret, and document clinical studies in collaboration with clinical operations, safety, regulatory, biometrics, biomarkers, and translational research teams.
  • Generate, author, update, and review protocols, informed consent documents, investigator brochures, clinical study reports, manuscripts, and clinical sections of regulatory submissions.
  • Provide clinical and scientific support to investigators, CROs, study sites, IRBs/IECs, and health authorities, including medical monitoring and patient eligibility questions.
  • Review and interpret clinical trial data and present findings internally and externally.
  • Build investigator and opinion-leader networks, organize advisory boards and investigator meetings, and support advocacy-group engagement.

Requirements

  • MD, PharmD, PhD, or equivalent clinical or scientific education, training, and experience.
  • At least 10 years of successful experience in biotech or pharmaceutical companies.
  • Previous participation in clinical development programs, ideally taking at least one study from start-up through final study report.
  • Clinical oncology experience, or exceptional therapeutic-area experience with clear potential to transition to oncology.
  • Expert understanding of global clinical study design and the drug development process from discovery through registration and post-marketing.
  • Knowledge of GCP and ICH Guidelines, clinical development IT solutions, SOPs, and compliant business practices.

Nice to have

  • Experience with therapeutic-area research, competitor analysis, clinical development process improvement, and resource planning.
  • Experience presenting at key opinion leader advisory boards and investigator meetings.

Culture & Benefits

  • Collaborative, bold, dedicated, and candid working culture.
  • Medical, dental, and vision insurance.
  • 401(k) match, flexible time off, and paid holidays including a year-end shutdown.
  • Annual performance incentive bonus, new-hire equity, and ongoing performance-based equity.

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