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4 дня назад

Senior Director, Drug Development (Oncology)

Формат работы
remote (только Europe)
Тип работы
fulltime
Грейд
senior/director
Английский
b2
Страна
Europe
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 Director, Drug Development (Oncology) (Regulatory Strategy/Clinical Development): Leading regulatory strategy and drug development programs for emerging biopharmaceutical companies in oncology across preclinical development, clinical development, and marketing approval with an accent on INDs, NDA/BLA/MAA submissions, FDA and EMA engagement, and lifecycle management. Focus on developing global regulatory teams, evaluating regulatory success risks, designing clinical and product development strategies, and advising clients on complex pharmaceutical, biologic, and advanced therapy programs.

Location: Home-based in Europe; Reading, Berkshire, United Kingdom

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Lead regulatory strategies for drug development, INDs, marketing and licensing applications, special designations, product lifecycle management, and portfolio management.
  • Advise customers on clinical development and navigation of US and European regulatory frameworks, including engagements with the FDA and EMA.
  • Lead and develop a global regulatory team, including line management responsibilities.
  • Assess regulatory risks and probability of success, develop mitigations, and contribute to indication prioritization, development strategies, gap analyses, and due diligence.
  • Develop integrated preclinical, clinical, regulatory, and commercial strategies for drugs, biologics, and advanced therapies, including TPPs, CDPs, clinical study designs, synopses, and protocols.
  • Support customer senior management, strategic business development, scientific communications, and professional conferences.

Requirements

  • Master’s degree or higher, or an equivalent combination of education, training, and experience.
  • 15–20+ years of relevant clinical research experience with a multi-regional and global focus, including significant senior strategic experience.
  • Broad management and leadership experience with the ability to lead multiple job areas and influence others.
  • Expertise in Excel and PowerPoint, with strong strategic thinking, analytical, communication, and presentation skills.
  • Experience providing client-focused strategic consulting, analytical and market research expertise, and regulatory or product development insight.
  • Strong commitment to quality, scientific integrity, and achievement of business objectives.

Culture & Benefits

  • Remote, home-based work arrangement in Europe.
  • Work with cross-functional teams across clinical research, therapeutic units, CRO operations, and business operations.
  • Opportunities to contribute to scientific publications, white papers, blogs, conferences, and webinars.
  • Engagement with innovative pharmaceutical, biologic, and advanced therapy development programs.

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Categories

Jobs in Europe