Clinical Strategy Director
hace 6 días
We are seeking an experienced Clinical Strategy Director - Regulatory Affairs to provide expert strategic advice on clinical and regulatory matters for global drug development projects. In this role, you will serve as a key leader, working closely with project teams to guide clinical development and regulatory strategies.
Key Responsibilities:- Strategic Regulatory Guidance: Provide strategic regulatory advice and support to project teams, ensuring alignment with global regulatory requirements, timelines, and best practices.
- Clinical Development Oversight: Oversee all clinical development activities, ensuring that clinical strategies are aligned with overall project goals and regulatory expectations.
- Global Regulatory Planning: Develop and execute a comprehensive global regulatory plan, including submission timelines, regulatory milestones, and risk mitigation strategies.
- Agency Interaction Leadership: Lead the development and implementation of the global agency interaction strategy, managing relationships with key regulatory bodies (e.g., FDA, EMA) and ensuring effective communication and submissions.
- Cross-functional Collaboration: Collaborate with internal and external stakeholders, including clinical operations, medical affairs, regulatory affairs, and project management, to ensure cohesive execution of clinical development strategies.
- Regulatory Submission Expertise: Drive the preparation, review, and submission of clinical documentation (e.g., IND, NDA, MAA) to regulatory agencies, ensuring accuracy and compliance with local and international guidelines.
- Risk Management: Identify potential regulatory and clinical risks and develop proactive strategies to mitigate them throughout the drug development lifecycle.
- Mentorship and Leadership: Provide leadership and mentoring to junior team members and other stakeholders involved in clinical and regulatory processes, fostering a culture of knowledge sharing and continuous improvement.
- Stay Updated on Industry Trends: Monitor changes in global regulatory landscapes, assess their impact on current and future projects, and adjust strategies accordingly to maintain compliance and competitive advantage.
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Clinical Affairs Director
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Clinical Affairs Director
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Senior Director of Clinical Affairs, EMEA RM
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Medical Director
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Senior Director of Clinical Affairs, EMEA RM
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Madrid, Madrid, España Boston Scientific Gruppe A tiempo completoJob Summary: We are seeking a Senior Director of Clinical Affairs, EMEA RM to lead our clinical affairs strategy in the EMEA region. The ideal candidate will have a deep understanding of clinical affairs and a proven track record in managing high-performing teams.Key Responsibilities:Develop and execute a comprehensive clinical affairs strategy for the EMEA...
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Clinical Data Science Director
hace 1 semana
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Clinical Operations Director
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Oncology Clinical Research Director
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Madrid, Madrid, España Clearcorrect A tiempo completoGlobal Clinical Affairs Director, OrthodonticsClearCorrect is seeking a highly skilled and experienced professional to lead our global clinical affairs strategy for orthodontics. As a key member of our leadership team, you will be responsible for developing and implementing clinical treatment protocols, leading education initiatives, and engaging with key...
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Medical Director
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Clinical Operations Director for Global Clinical Research
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Clinical Delivery Director
hace 4 semanas
Madrid, Madrid, España MAI Fortrea Development Limited A tiempo completoAs a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience, MAI Fortrea Development Limited provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.The...
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Clinical Delivery Director
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Medical Director
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Clinical Affairs Director, EMEA Region
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