Senior Clinical development Director
4 weeks ago
Senior Director Haematology/Rare Disease
As the Senior Director of Clinical Development for the rare haematological disease portfolio, you will lead ground-breaking clinical initiatives, overseeing Clinical development and global regulatory filing.
Responsibility:
- Lead global regulatory engagement for multiple programs, preparing regulatory documents and submissions, collaborating with clinical development and other teams.
- Offer clinical and strategic guidance for various study-related documents, including study reports, regulatory filings, protocols, and investigator brochures, working closely with cross-functional teams.
- Provide clinical leadership for ongoing programs in rare bleeding disorders, contributing to pipeline development strategy and external partnerships.
- Communicate program activities to senior leadership and represent the company to external stakeholders, including investigators and advocacy groups.
- Support ongoing clinical trials by ensuring efficient study execution, data analysis, and serving as a backup Medical Monitor when necessary.
What You'll Bring:
- MD, MD/PhD, DO, or equivalent
- Minimum 4 years of industry experience in clinical development
- Global clinical development and regulatory interaction experience
- BLA/MAA filing experience preferred
- Background in bleeding disorders preferred
- Strong collaborative and problem-solving skills
- Excellent communication abilities
Please reach out to shaun@dnalifesciecnes.co.uk
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