Vertex Pharmaceuticals is searching for an experienced Senior Medical Director to manage a franchise of neurology assets. The Sr. Medical Director will oversee the clinical development strategy for both early stage research compounds and mid stage clinical compounds, align with the broader strategy of the multi-functional project teams, and coordinate and monitor the clinical studies to be carried out in support of the development plan for these compounds.
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In conjunction with other relevant functional areas, develop the strategic development plan for this compound
Act as the US/international clinical lead for the compound to both internally and externally facing stakeholders by providing high level input
Oversee the writing of protocols, the conduct of trials and the analyses of data for this compound
Interface with US/international regulatory authorities, as appropriate, in support of the development objectives for these compounds and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries
Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems independently
Ensure compliance with Vertex SOPs, ICH, GCP and other national and international regulatory requirements
Minimum Qualifications Minimum Qualifications:
• MD, DO or the International equivalent.
• Minimum of 5 years Pharmaceutical/Biotech industry experience, including time managing clinical trials and/or clinical development program(s) Neurology training and/or industry background.
• Board certification/eligibility in specialty area.
Preferred Qualifications:
• Ability to work collaboratively in a challenging team matrix environment.
• Ability to work independently to resolve challenges and conflicts
• Possess a comprehensive understanding of applicable US and EU regulatory requirements and of the drug development process
• Have a working knowledge of biostatistics, data management, clinical operations and clinical pharmacokinetic scientific and technical processes
• Experience in filing and defending US INDs and/or NDAs
• Excellent communication skills
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