Senior Director, Clinical Development

Overview

Seaport Therapeutics is a clinical-stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph

TM technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders.

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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 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, and a passion for partnering with high-performing teams and advancing innovative therapies in neurological and neuropsychiatric diseases.

The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a “we own it” mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston’s Seaport area, with a strong preference for being onsite 4 days per week.

• Establish 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, including with members of the executive leadership team, regulatory affairs, clinical operations and medical affairs, and externally with 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
• 5+ 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…