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2 дня назад

Director, Clinical Science (Oncology)

220 000 - 250 000$
Тип работы
fulltime
Грейд
director
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
Director, Clinical Science (Oncology): Leading clinical science activities for oncology trials, including protocol development, safety and efficacy evaluation, clinical data analysis, and regulatory documentation with an accent on Phase 3 breast cancer studies and cross-functional drug development. Focus on analyzing study-level and subject-level data, identifying safety events, supporting clinical study reports, and collaborating with investigators, medical monitors, and regulatory teams.

Location: Based out of the San Francisco, CA or Cambridge, MA office; up to 20% travel required

Salary: $220,000–$250,000 annually, plus equity, bonus, and benefits.

Company

hirify.global is a clinical-stage biopharmaceutical company developing oncology therapies, including palazestrant and OP-3136, to improve outcomes for people living with breast cancer.

What you will do

  • Lead clinical science activities for an ongoing oncology clinical study in collaboration with Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory, and Program Management.
  • Write and review protocols, amendments, investigator brochures, regulatory documents, clinical study reports, abstracts, publications, and scientific presentations.
  • Evaluate safety, pharmacology, efficacy, and ongoing clinical data, identifying and tracking potential safety events.
  • Organize study-level and individual subject-level analyses to generate insights and support clinical study report development.
  • Collaborate with investigators and oncology thought leaders on clinical synopses, protocols, and study strategy.
  • Support enrollment packet reviews, informed consent forms, case report forms, site visit materials, investigator meetings, and scientific meeting activities.

Requirements

  • Oncology clinical development experience is required, with comprehensive knowledge of oncology clinical trial implementation and the drug development process.
  • At least 8 years of experience in the biotechnology or pharmaceutical industry.
  • Strong knowledge of Good Clinical Practices, FDA regulations, and EMEA/CHMP regulations and guidelines.
  • Demonstrated ability to execute drug development strategies, meet milestones, identify challenges, and propose solutions.
  • Strong written and oral communication skills, attention to detail, and ability to work effectively in cross-functional teams.
  • Advanced degree such as a PhD or PharmD is strongly preferred.

Nice to have

  • Familiarity with additional international regulatory requirements.
  • Experience motivating internal and external collaborators and fostering teamwork.

Culture & Benefits

  • Open, flexible, and friendly work environment.
  • Competitive compensation and benefits package, including equity and bonus.
  • Equal opportunity workplace that values diverse expertise, backgrounds, and experience.
  • Opportunities to develop a long-term career in a growing oncology company.

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