3 дня назад
Scientific Associate Director - Project Toxicologist (Biotech)
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Описание вакансии
Текст:
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
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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