3 дня назад
Senior Clinical Lead, Early Clinical & Experimental Therapeutics (Oncology)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Clinical Lead, Early Clinical & Experimental Therapeutics (Oncology) (oncology clinical development): Designing and leading early clinical development for oncology assets from preclinical translation through Phase 2a with an accent on first-in-human studies, proof-of-mechanism, proof-of-concept, and human target validation. Focus on dose escalation, medical safety oversight, biomarker and translational data interpretation, and coordinating cross-functional teams and CROs.
Location: Hybrid role based in Cambridge, Massachusetts or Morristown, New Jersey, United States
Company
is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines through immunoscience and an innovative pipeline.
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 studies.
- Make front-line decisions on protocol design, dose escalation, safety, dose selection, and early Go/No-Go decisions.
- Provide medical and clinical expertise for preclinical data generation, translational medicine, biomarker research, and human target validation.
- Oversee medical monitoring, study safety, CROs, clinical operations, regulatory activities, and cross-functional study execution.
- Review and author clinical protocols, informed consent forms, study reports, regulatory documents, key results memos, and clinical study reports.
Requirements
- Advanced degree: M.D. or M.D./Ph.D. required.
- At least 3 years of clinical research experience, including oversight of patients in early Phase 1/2a trials and interpretation of preclinical and biomarker data.
- Experience designing and executing early development clinical trials and exploratory studies in pharmaceutical, academic, hospital, clinical site, or CRO settings.
- Experience leading cross-functional teams and providing medical safety oversight for clinical trials.
- Knowledge of broad biomedical principles, GCP practices, translational and biomarker research, and risk-based decision-making in matrix organizations.
- English required for global interactions. Experience with emerging digital and AI-driven tools is also required.
Nice to have
- MD and PhD, or analogous bench science experience.
- Experience in a global pharmaceutical setting.
- Medical or scientific experience with combination therapies and drugs targeting cytoplasmic signaling pathways.
- Postgraduate residency training, laboratory research, or experience conducting late-phase clinical trials.
Culture & Benefits
- Supportive, future-focused R&D environment centered on bringing scientific discoveries to patients.
- Opportunities for career growth through promotion or lateral and international moves.
- Rewards package aligned with contribution and impact.
- Healthcare, prevention, wellness, and family-support benefits.
- At least 14 weeks of gender-neutral parental leave.
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