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2 дня назад

Clinical Development Executive Medical Director (Oncology)

274 000 - 456 600$
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
Clinical Development Executive Medical Director (Oncology): Defining and executing the clinical development strategy for Enfortumab vedotin with an accent on trial design, cross-functional leadership, safety, and regulatory submissions. Focus on leading the Global Development Team, interpreting clinical data, guiding health-authority interactions, and making complex development and dose-selection decisions.

Location: Hybrid role in Bothell, Washington, United States; permanent U.S. work authorization required.

Annual base salary: $274,000–$456,600, plus a 30% bonus target and eligibility for a share-based long-term incentive program.

Company

hirify.global is a pharmaceutical company developing medicines and conducting clinical research across therapeutic areas.

What you will do

  • Define and execute the clinical development strategy and plan for Enfortumab vedotin in the GU therapeutic area.
  • Lead the product-specific Global Development Team and coordinate regulatory, statistical, safety, clinical pharmacology, and external stakeholder input.
  • Oversee trial design, execution, protocols, amendments, investigator brochures, clinical study reports, and delivery of trial results.
  • Evaluate, interpret, report, present, and publish clinical study data while guiding safety and clinical decisions.
  • Lead clinical content preparation for NDA, MAA, IND, sNDA, labeling, and other regulatory submissions.
  • Lead or contribute to health-authority meetings, regulatory responses, and appropriate business-development due diligence.

Requirements

  • Medical degree or advanced degree with relevant clinical or industry experience.
  • 7+ years of industry experience and 5+ years leading diverse teams.
  • Prior management responsibility for medical directors or clinical scientists.
  • Experience across clinical development phases and oncology drug classes.
  • Ability to travel globally and work outside typical hours when required for other time zones or time-sensitive business needs.
  • Permanent authorization to work in the United States; U.S. work visa sponsorship is not available.

Nice to have

  • Board certification or eligibility in oncology or an equivalent qualification.
  • Experience leading NDA, BLA, or MAA submissions.

Culture & Benefits

  • Hybrid work location with occasional global travel.
  • Relocation assistance may be available based on business needs and eligibility.
  • Comprehensive medical, prescription drug, dental, and vision coverage.
  • 401(k) matching contributions and an additional retirement savings contribution.
  • Paid vacation, holidays, personal days, caregiver and parental leave, and medical leave.

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