Seaporttherapeutics
Executive Director/Vice President, Clinical Development
Boston, MA. Posted 10 months ago
The role
This leader will drive strategic and operational execution of global clinical programs for current and future pipeline assets. The role involves overseeing clinical trial design and execution while partnering with regulatory strategy, biostatistics, and external partners.
What you will do
- Establish and drive clinical development strategy and tactical execution plans
- Manage internal and external relationships with leadership, regulatory, clinical operations, and partners
- Provide medical oversight of ongoing clinical trials in the neuropsychiatric therapeutic area
- Lead clinical sections of regulatory documents including IND and BLA/NDA
- Work with Regulatory Affairs to prepare for meetings with FDA and healthcare authorities
- Work with Scientific Communications and Medical Affairs to organize advisory board meetings
- Work with Program team members through all phases of development through commercialization
- Prioritize drug candidates and contribute to go/no-go decisions
- Conduct literature reviews, KOL interactions, and present clinical development plans
- Ensure SOPs for Clinical Development are compliant with clinical, medical, and industry standards
Required qualifications
- MD training in psychiatry and/or neuroscience
- 8+ years of clinical development experience for ED
- 10+ years of clinical development experience for VP
- Clinical development experience within a biotech/pharmaceutical setting
- Prior clinical/academic experience
- Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, and interpretation of clinical data
- Experience in generation of supporting regulatory submissions of clinical study documents
- Experience in Phases I-III clinical development
- Understanding of the general healthcare environment in the US and elsewhere
- Knowledge and experience of building clinical development infrastructure
Nice to have
- Experience with mood/anxiety disorders
- Experience with successful NDA submissions and approvals and interactions with regulatory agencies
About the company
Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines using its proprietary Glyph technology platform.