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2 дня назад

Director, Clinical Science

201 840 - 302 760$
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 Science (Clinical Research): Leading clinical development plans, study designs, protocols, clinical trial execution, and regulatory submissions with an accent on late-phase studies, biomarker and pharmacokinetic strategy, and cross-functional scientific leadership. Focus on overseeing pivotal trials, reviewing emerging clinical data, managing study risks and deliverables, and guiding interactions with regulatory agencies, CROs, and external experts.

Location: Basking Ridge, New Jersey, United States

Salary: $201,840–$302,760 per year

Company

hirify.global is a global pharmaceutical company developing innovative therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.

What you will do

  • Lead development plans, study designs, protocols, informed consent forms, and clinical sections of regulatory documents.
  • Oversee large, late-phase and potentially pivotal clinical trials, including recruitment, retention, compliance, risk management, and contingency planning.
  • Direct biomarker, pharmacokinetic/pharmacodynamic, data review, statistical analysis, and data quality strategies with cross-functional teams.
  • Review emerging clinical data, lead dose-escalation meetings, and ensure timely delivery of clinical milestones and outputs.
  • Represent Clinical Science in integrated and operational project teams and serve as a subject matter expert for Clinical Operations, CROs, AROs, and vendors.
  • Lead regulatory and external interactions with health authorities, IRBs, key opinion leaders, advisory boards, and internal experts.

Requirements

  • Bachelor's degree in life sciences or a related field.
  • 10+ years of relevant clinical experience.
  • Experience leading large, late-phase clinical studies, including Phase 2/3 or Phase 3 trials.
  • Advanced expertise in preclinical and clinical research, protocol writing, data review, study design, and clinical trial strategy.
  • Ability to travel up to 20% of the time.

Nice to have

  • Master's degree, PharmD, PhD, or equivalent qualification.
  • Postgraduate training in a therapeutic area or related specialty.
  • Hematology experience.

Culture & Benefits

  • Work within a global pharmaceutical organization focused on innovative medicines and unmet medical needs.
  • Collaborate with scientific, clinical, regulatory, commercial, and external stakeholders.
  • Participate in program strategy, in-licensing, acquisition due diligence, and performance-based team development.
  • Full-time professional employment with a benefits program.

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