Назад
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2 часа назад

Associate Director, Clinical Sciences, Oncology

158 600 - 285 500$
Формат работы
hybrid
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
Associate Director, Clinical Sciences, Oncology (clinical development): Supporting Phase 1–3 oncology clinical studies by overseeing study delivery, clinical data quality, safety monitoring, regulatory documentation, and collaboration with clinical trial teams. with an accent on clinical data integrity, exploratory analysis, protocol execution, and regulatory submissions. Focus on coordinating global site activation and enrollment, interpreting clinical data, managing safety decisions, and preparing protocols, DSURs, Investigator Brochures, INDs, and marketing applications.

Location: Cambridge, Massachusetts, or Princeton, New Jersey, United States; 70% in-office and up to 30% work from home. Travel of up to 15% is required for study sites and national and international scientific congresses. Only U.S. persons are eligible due to U.S. export control requirements; visa sponsorship is not available.

Salary: $158,600–$285,500 per year, with potential annual bonus, incentive compensation, or equity award.

Company

hirify.global develops an mRNA technology platform and medicines intended to transform how treatments are created and delivered.

What you will do

  • Support the Clinical Study Lead in developing, executing, evaluating, and closing Phase 1–3 oncology clinical studies.
  • Oversee study design, site activation, subject enrollment, operational risk reduction, inspection readiness, and end-to-end protocol delivery.
  • Coordinate clinical data review and analysis, including case report forms, data listings, medical coding, patient profiles, and exploratory analyses.
  • Review and interpret clinical data and collaborate with Clinical Operations, Clinical Safety & Pharmacovigilance, external partners, and broader clinical trial teams.
  • Support study-site safety decisions and contribute to Investigator Meetings, investigator engagements, and Advisory Board meetings.
  • Author and review protocols, informed consent documents, DSURs, Investigator Brochures, INDs, and clinical components of marketing applications.

Requirements

  • PhD, PharmD, master’s degree, or advanced nursing degree with significant scientific and clinical oncology knowledge.
  • At least 8 years of clinical development experience in a pharmaceutical or biotechnology company, with substantial drug development knowledge.
  • Demonstrated experience ensuring clinical trial data integrity, performing data analysis, and presenting clinical data.
  • Ability to work effectively in a team and matrix environment, with excellent written, oral, and presentation skills.
  • Experience with Medidata Rave and clinical data analytics platforms such as Elluminate or Spotfire is preferred.
  • Must qualify as a U.S. person under U.S. export control laws; the role requires 70% in-office presence in Cambridge or Princeton.

Nice to have

  • Strong early- and late-stage clinical development experience.
  • Outstanding oncology expertise and a record of well-executed clinical research.
  • Experience collaborating with Drug Discovery, Translational Medicine, Regulatory Affairs, Biostatistics, Medical Affairs, and Commercial functions.
  • Highly developed interpersonal and communication skills, with a commitment to high ethical standards.

Culture & Benefits

  • 70/30 in-office working model emphasizing collaboration, innovation, teamwork, and mentorship.
  • Healthcare coverage and voluntary benefit programs.
  • Fitness, mindfulness, mental health, family planning, fertility, adoption, and surrogacy support.
  • Paid vacation, volunteer days, sabbatical, global recharge days, and discretionary year-end shutdown.
  • Savings and investment programs, plus location-specific perks.

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