1 день назад
Senior Clinical Research Director
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Director (Clinical Development/Hematology): Leading the fitusiran registrational development program and ongoing global regulatory submissions with an accent on clinical strategy, study execution, medical oversight, and scientific data evaluation. Focus on developing clinical development plans, resolving cross-functional study issues, preparing submission dossiers, and ensuring compliance with regulations and health authority guidance.
Location: Cambridge, Massachusetts, United States; hybrid
Company
presents an opportunity with Sanofi, an R&D-driven biopharmaceutical company developing medicines and vaccines for immune challenges, rare diseases, blood disorders, cancer, and neurological disorders.
What you will do
- Serve as the primary Clinical Lead for the fitusiran registrational development program and ongoing global regulatory submissions.
- Develop and implement clinical development plan strategies.
- Lead and oversee clinical development and study activities.
- Coordinate with Clinical Research Directors, Clinical Scientists, and cross-functional stakeholders to resolve clinical study issues.
- Contribute to clinical submission dossiers, regulatory and safety documents, and health authority meetings.
- Act as the medical reference, evaluate and disseminate scientific data, and ensure compliance with regulations, laws, health authority guidance, and company policies.
Requirements
- Medical Doctor or equivalent with specialist training in Hematology, Internal Medicine, Pediatrics, or another relevant specialty.
- At least 8 years of experience.
- Strong scientific and clinical background with a deep understanding of the therapeutic field.
- Expertise in clinical development and clinical study methodology, plus understanding of pharmaceutical product development and life-cycle management.
- Strong communication, problem-solving, decision-making, leadership, and cross-functional collaboration skills.
- Fluent English, spoken and written, is required.
Nice to have
- MD/PhD degree.
Culture & Benefits
- Supportive, future-focused, and collaborative work environment.
- Opportunities for career growth through promotion or lateral moves, including international opportunities.
- Employee rewards, healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Patient insights are incorporated early into drug development and study design.
- Access to AI, data, and digital platforms supporting drug discovery and development.
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