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3 дня назад

Senior Clinical Lead, Early Clinical & Experimental Therapeutics (Oncology)

Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global 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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