19 часов назад
Senior Medical Director, Clinical Development (Autoimmune Clinical Trials)
275 000 - 300 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Medical Director, Clinical Development (Autoimmune Clinical Trials): Leading the design and implementation of autoimmune clinical studies and shaping clinical development strategy with an accent on medical monitoring, safety review, and cross-functional drug development. Focus on translating research findings into clinical opportunities, developing regulatory and clinical deliverables, and guiding investigator and stakeholder interactions across Phase I–III programs.
Location: San Carlos, California or remote within the United States. Work authorization in the United States is required; travel may be up to 25%.
Base pay: $275,000–$300,000 per year, with equity incentives and employer-sponsored benefits.
Company
is a privately held, clinical-stage biopharmaceutical company developing antibody therapeutics for cancer, autoimmune disorders, and other serious diseases.
What you will do
- Develop clinical development plans and lead the design and implementation of autoimmune clinical studies.
- Serve as clinical lead and medical monitor for one or more studies.
- Contribute to protocols, investigator brochures, clinical study reports, regulatory documents, publications, and other clinical deliverables.
- Review and interpret ongoing safety data in collaboration with pharmacovigilance.
- Conduct investigator meetings and lead site initiation visits.
- Translate research and nonclinical findings into clinical opportunities while collaborating with internal and external stakeholders.
Requirements
- M.D. degree; specialization in immunodermatology is preferred.
- At least 4 years of industry or relevant drug development experience managing and executing Phase I–III trials.
- Experience serving as a medical monitor for early-stage autoimmune clinical trials.
- Experience designing, implementing, and conducting clinical trials, including knowledge of the autoimmune clinical and regulatory landscape.
- Familiarity with U.S. and international regulatory frameworks, including CFR 21, ICH, and GCP.
- Must be permitted to work in the United States; willingness to travel up to 25%.
Culture & Benefits
- Work in a clinical-stage biopharmaceutical environment with cross-functional collaboration across research, clinical operations, regulatory, safety, medical affairs, and commercial functions.
- Competitive cash compensation and equity incentive awards.
- Employer-sponsored benefits.
- Fast-paced environment requiring independent judgment, adaptability, and strategic leadership.
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