2 дня назад
Safety Pharmacology Senior Scientist (Biotechnology)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Safety Pharmacology Senior Scientist (Biotechnology): Developing and executing integrated nonclinical safety pharmacology strategies for discovery, candidate selection, IND-enabling packages, and regulatory submissions with an accent on cardiovascular, respiratory, and CNS assessments. Focus on designing GLP and non-GLP studies, integrating translational safety data, and translating complex findings into regulatory and development recommendations.
Location: Thousand Oaks, California, United States
Company
is a biotechnology company developing and delivering medicines for serious diseases across oncology, inflammation, general medicine, and rare disease.
What you will do
- Serve as a safety pharmacology subject matter expert on cross-functional project teams across discovery, candidate selection, IND-enabling, and clinical development stages.
- Develop integrated safety pharmacology strategies aligned with program biology, modality, target risk, regulatory expectations, and development needs.
- Design and oversee GLP and non-GLP studies conducted internally or through contract research organizations.
- Evaluate cardiovascular, respiratory, CNS, ECG, hemodynamic, telemetry, and related nonclinical safety endpoints.
- Integrate safety pharmacology findings with toxicology, pharmacology, translational biology, DMPK, clinical, and regulatory data.
- Contribute to governance discussions, regulatory documents, scientific publications, presentations, and external working groups.
Requirements
- Doctorate degree and 1 year of scientific experience, or a master’s degree and 3 years of experience, or a bachelor’s degree and 5 years of experience.
- Experience in nonclinical safety pharmacology across cardiovascular, respiratory, and CNS domains.
- Experience supporting discovery and development project teams as a safety pharmacology subject matter expert or toxicology representative.
- Experience serving as a study director, project representative, or subject matter expert for GLP and/or non-GLP safety pharmacology studies.
- Experience authoring or contributing to regulatory documents, including Investigator’s Brochures, IND sections, briefing documents, or regulatory responses.
- Strong cross-functional communication, scientific judgment, problem-solving, collaboration, and prioritization skills.
Nice to have
- PhD in Pharmacology, Neuroscience, Physiology, Biomedical Sciences, or a related field.
- Track record of scientific publications and participation in external scientific forums or consortia.
Culture & Benefits
- Collaborative, innovative, and science-based working environment.
- Health, dental, vision, life, disability, and flexible spending benefits.
- Retirement and savings plan with company contributions.
- Discretionary annual bonus program and stock-based long-term incentives.
- Paid time off and career development opportunities.
- Flexible work models where applicable to the position.
Hiring process
- Applications are accepted until a sufficient number of candidates is received or a candidate is selected.
- Sponsorship for this role is not guaranteed.
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