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3 дня назад

Scientific Associate Director - Project Toxicologist (Biotech)

Формат работы
remote (только USA)/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
Scientific Associate Director - Project Toxicologist (Biotech): Developing and implementing nonclinical safety strategies for innovative therapeutics across multiple modalities and therapeutic areas with an accent on translational risk assessment, regulatory alignment, and cross-functional project leadership. Focus on designing complex safety studies, integrating AI-enabled approaches and New Approach Methodologies, interpreting experimental data, and supporting first-in-human applications and marketing authorizations.

Location: Washington D.C., District of Columbia, United States. Flexible remote and hybrid work arrangements may be available where possible.

Company

hirify.global is a biotechnology company developing and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare diseases.

What you will do

  • Serve as the Translational Safety & Risk Sciences representative on cross-functional project teams from discovery through post-marketing.
  • Lead TSRS sub-teams and coordinate scientific input for human risk assessment and development strategy.
  • Design, oversee, and interpret nonclinical safety assessment programs for biotherapeutics, small molecules, targeted protein degraders, RNA-based therapies, and other modalities.
  • Develop innovative study designs using AI-enabled approaches and New Approach Methodologies to address complex scientific questions.
  • Author nonclinical strategy, governance, and regulatory submission content, including first-in-human applications and marketing authorizations.
  • Collaborate with internal scientists and external partners, support due diligence activities, and mentor fellow scientists.

Requirements

  • Doctorate degree in toxicology or a related field with at least 4 years of toxicology experience; alternatively, a master’s degree with 7 years or a bachelor’s degree with 9 years of toxicology experience.
  • Experience in drug development as a Project Toxicologist or Nonclinical Safety Project Team Representative, including late-stage assets and interactions with global regulatory agencies.
  • End-to-end safety assessment experience across small and large molecules, multiple therapeutic areas, and multiple modalities.
  • Proven ability to influence cross-functional teams, lead in a matrixed environment, and communicate with scientific, business, and regulatory stakeholders.
  • Experience with nonclinical safety assessment, regulatory submissions, and complex scientific risk assessment.

Nice to have

  • Experience with siRNA therapeutics, antibody-drug conjugates, antibody-peptide conjugates, or targeted protein degraders.
  • Subject matter expertise in a defined toxicology area, such as drug-induced liver injury.
  • American Board of Toxicology certification.
  • Experience supporting business development due diligence and external scientific presentations or publications.

Culture & Benefits

  • Collaborative, innovative, science-based working environment.
  • Health, dental, vision, life, disability, and flexible spending benefits.
  • Retirement and savings plans with company contributions.
  • Annual bonus opportunities, stock-based long-term incentives, and paid time off.
  • Career development support and flexible work models, including remote and hybrid arrangements where possible.

Hiring process

  • Applications are accepted until the position is filled; no fixed application deadline is stated.
  • Sponsorship for this role is not guaranteed.

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