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The Senior Director, Clinical Development is responsible for providing the medical input and medical oversight for an immunology or neuroscience clinical development program(s). Strategic responsibilities include scientific support design and execution of clinical development plans for the respective therapeutic or disease area through all stages of development The incumbent will be responsible for leading clinical trials, developing and authoring the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.), reviewing study data and providing expert clinical input.The role may incorporate higher responsibilities in Senior Stakeholder Management, Regulatory interactions, and being able to provide input at wider R&D level for the company, acquire ad hoc various senior level responsibilities and assignments and contribute to licensing opportunities.
Travel Requirements: Travel expected (up to approximately 20% of business days)
Essential Duties & Responsibilities:
Required:
Specialized or Technical Knowledge Licenses, Certifications needed:
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