7 дней назад
Clinical Lead Early Development and Experimental Therapeutics - Oncology
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Clinical Lead Early Development and Experimental Therapeutics - Oncology (Oncology/Translational Medicine): Designing and leading early clinical development for oncology assets from preclinical research through phase 2a, with an accent on First-In-Human studies, human target validation, biomarkers, and proof-of-mechanism. Focus on making dose-escalation and safety decisions, coordinating cross-functional teams and CROs, and interpreting clinical, pharmacokinetic, and translational data.
Location: Hybrid role based in Cambridge, Massachusetts or Morristown, New Jersey, United States
Company
R&D-driven, AI-powered biopharma company developing medicines and vaccines through immunoscience, translational research, and clinical development.
What you will do
- Design and lead early clinical development programs for oncology assets, including small molecules, monoclonal antibodies, antibody-drug conjugates, and immune cell engagers.
- Develop and oversee First-In-Human through phase 2a studies, including natural history, mechanistic, signal-seeking, proof-of-mechanism, and proof-of-concept trials.
- Make clinical decisions related to protocol design, dose escalation, safety, dose selection, and early Go/No Go assessments.
- Provide medical monitoring, review adverse events, interpret clinical and translational data, and oversee study safety.
- Coordinate regulatory, safety, biostatistics, biomarker, pharmacokinetic, clinical operations, and CRO activities.
- Review and author clinical protocols, informed consent forms, investigator brochures, regulatory documents, key results memos, and clinical study reports.
Requirements
- M.D. or equivalent required.
- At least 3 years of clinical research experience.
- English required for global cross-functional, CRO, investigator, and regulatory interactions.
- Experience with early clinical trials, preferably First-In-Human and phase 1/2a studies, and interpretation of preclinical or biomarker data.
- Experience leading cross-functional teams and providing medical safety oversight for clinical trials.
- Knowledge of GCP practices, translational medicine, clinical trial design, and biomedical research.
Nice to have
- MD plus PhD or equivalent bench science experience.
- Experience with combination therapies, cytoplasmic signaling pathways, late-phase clinical trials, or global pharmaceutical development.
- Experience using emerging digital and AI-driven tools and solutions.
- Postgraduate residency training and laboratory research experience.
Culture & Benefits
- Collaborative, future-focused environment spanning research, clinical development, regulatory, safety, and operations.
- Opportunities for professional growth through promotion or lateral career moves.
- Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Work with AI, data, and digital platforms to accelerate drug development and incorporate patient insights into study design.
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