12 часов назад
Senior Clinical Research Director (AI)
236 250 - 393 750$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Research Director (AI): Leading the fitusiran registrational development program and global regulatory submissions with an accent on clinical development strategy, study execution, medical data interpretation, and regulatory compliance. Focus on evaluating and disseminating scientific data, resolving complex clinical study issues, and coordinating cross-functional teams across the drug development lifecycle.
Location: Cambridge, MA, United States; hybrid
Salary: $236,250–$393,750 per year, commensurate with experience.
Company
is an R&D-driven, AI-powered 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 strategies 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 sections of submission dossiers, regulatory and safety documents, and agency meetings.
- Act as the medical reference for the team, ensuring the medical relevance of clinical data.
- Lead scientific data evaluation and dissemination while ensuring compliance with regulations, 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 in clinical development or a related area.
- Strong scientific and clinical background with deep knowledge of the therapeutic field and clinical study methodology.
- Understanding of pharmaceutical product development and lifecycle management.
- Excellent communication, problem-solving, decision-making, leadership, and cross-functional collaboration skills.
- Fluent English, spoken and written, required.
Nice to have
- MD/PhD degree.
Culture & Benefits
- Supportive, future-focused environment with opportunities for promotion and international career development.
- Health, wellbeing, prevention, and wellness benefits.
- 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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