1 месяц назад
VP, Toxicology
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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