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1 месяц назад

VP, Toxicology

Формат работы
remote (только USA)
Тип работы
fulltime
Грейд
c_level
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
VP, Toxicology (Biotechnology): Leading nonclinical safety and toxicology strategy for small molecule therapeutics from discovery through IND, clinical development, and NDA submission with an accent on regulatory compliance, study design, and cross-functional scientific leadership. Focus on designing IND-enabling programs, overseeing CROs and vendors, authoring FDA and ex-US regulatory materials, and building a high-performing nonclinical safety team.

Location: San Francisco, California (Remote)

Company

hirify.global is an early-stage biotechnology company developing next-generation non-opioid medicines for pain and pain-related syndromes.

What you will do

  • Lead nonclinical safety and toxicology strategy from early discovery through IND submission, clinical development, and NDA submission.
  • Provide toxicology and nonclinical safety leadership on cross-functional teams, including risk–benefit assessments and compound progression recommendations.
  • Design, oversee, and interpret IND-enabling toxicology and safety pharmacology studies.
  • Manage scientific oversight of CROs, consultants, and vendors, including protocols, data quality, and final reports.
  • Author and review nonclinical sections of INDs, investigator brochures, briefing documents, and regulatory responses.
  • Build and mentor a high-performing nonclinical safety team and advise senior R&D leadership on portfolio strategy.

Requirements

  • PhD, DVM, or equivalent degree in toxicology, pharmacology, or a related scientific discipline.
  • 15+ years of industry experience in nonclinical safety or toxicology within biotechnology or pharmaceutical settings.
  • Leadership experience with small molecule toxicology programs from IND-enabling studies through marketing applications.
  • Strong record of regulatory authorship and agency interactions supporting early development programs.
  • Experience leading cross-functional teams and influencing program- and portfolio-level development strategy.
  • Deep expertise in nonclinical safety and toxicology, with clear scientific communication and collaborative leadership skills.

Nice to have

  • Experience in pain or neuroscience-related therapeutic areas.
  • Experience working in a fast-paced, early-stage biotechnology environment.

Culture & Benefits

  • Science-, patient-, and innovation-focused working environment.
  • Opportunity to contribute to the development of novel non-opioid therapies.
  • Remote work arrangement associated with the San Francisco, California position.

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