Jobs at Seaport Therapeutics

Seaport Therapeutics is seeking a hands-on clinical development leader to drive the strategic and operational execution of our global clinical programs across current and future pipeline assets. This role will report to the Chief Medical Officer and oversee clinical trial design and execution, partner with regulatory strategy, biostatistics, program management and other cross-functional stakeholders and external partners including regulatory agencies, KOLs, and investigators. The ideal candidate will bring deep expertise in neuroscience or neurology, a proven track record of successful IND/NDA submissions, experience with Ph III clinical development, and a passion for partnering with high-performing teams and advancing innovative therapies in neurological and neuropsychiatric diseases.

• Establish and drive the clinical development strategy and hands-on tactical execution plans on programs against the current and future development portfolio.
• Manage effective internal and external relationships, internally with members of the executive leadership team, regulatory affairs, clinical operations and medical affairs, and externally including regulatory agencies, partners, KOLs, and investigators.
• Medical oversight of ongoing clinical trials in the neuropsychiatric therapeutic area.
• Lead clinical sections of regulatory documents (IND, BLA/NDA).
• Work with Regulatory Affairs to prepare for meetings with FDA and healthcare authorities.
• Work with Scientific Communications/ Medical Affairs team members to organize and prepare for advisory board meetings.
• Work with other members of the Program team through all phases of development through commercialization.
• Prioritize and develop the company’s current drug candidates as well as future pipeline compounds and contribute to go / no-go decisions.
• Literature review, KOL interactions, attending scientific meetings, and presenting the clinical development plan to the relevant internal stakeholders to help shape the new indication selection process.
• Ensure that standard operating procedures (SOP) for Clinical Development facilitate the development of effective clinical research protocols and are compliant with clinical/medical and industry standards.
• Actively participate in strategic planning for the clinical development organization and provide support to business development / licensing activities.
• Maintain an understanding of competitors and clinical developments in relevant therapeutic areas.
• Build and maintain medical advisory boards based on solid working relationships with KOLs and lead clinical investigators.

•  MD training in psychiatry and/or neuroscience required.
• 8+ (ED) 10+(VP) years of clinical development experience within a biotech/pharmaceutical setting with a strong track record of successful clinical program execution in the field of neuropsychiatric drug development. Prior clinical/academic experience required as well.
• Experience with mood/anxiety disorders preferred.
• Experience with GCP/ICH/FDA requirements, clinical trial design and strategies, interpretation of clinical data and generation of supporting regulatory submissions of clinical study documents.
• Demonstrated track record and experience working cross-functionally in a collaborative and productive manner across R&D functions and beyond.
• Exceptional interpersonal, influencing, presentation, and written and verbal communication skills.
• Experience with successful NDA submissions and approvals and interactions with regulatory agencies are highly desired.
• Experience with Phases I-III clinical development required.
• Understanding of the general healthcare environment in the US and elsewhere-including laws, regulations, and evolving market access trends and issues.
• Knowledge and experience of building clinical development infrastructure aligned with the needs of a growing organization.