2 дня назад
Director, Clinical Science (Oncology)
220 000 - 250 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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
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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