---
title: 'Director, Clinical Quality Assurance at Seaport Therapeutics'
canonical: 'https://feeny.ai/job/director-clinical-quality-assurance-seaport-therapeutics-boston-e2kywkseea5x'
type: 'job'
last_seen: '2026-09-06'
---

# Director, Clinical Quality Assurance at Seaport Therapeutics

- **Company:** Seaport Therapeutics
- **Location:** Boston, MA
- **Posted:** 2026-06-17
- **Last confirmed live:** 2026-09-06
- **Apply:** https://job-boards.greenhouse.io/seaporttherapeutics/jobs/5267316008

## Job description

Seaport Therapeutics is a clinical-stage therapeutics 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 GlyphTM 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. For more information, please visit [www.seaporttx.com](https://www.seaporttx.com/).

Seaport Therapeutics is seeking an experienced Director, Clinical Quality Assurance to manage clinical quality activities supporting clinical development programs, ensuring compliance with regulatory requirements and company policies. This role reports to the VP of Quality.

The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs. This role is responsible for developing and implementing risk-based strategies; managing audits, inspection readiness, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.

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.

Summary of Key Responsibilities

- Inform and contribute to audit planning and strategy
- Perform and/or coordinate clinical site and vendor audits
- Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs
- Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends
- Support inspection readiness activities and co-host regulatory inspections
- Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements
- Conduct and/or manage the qualification and oversight of service providers
- Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness
- Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity
- Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings
- Support investigational new drug (IND) applications and related correspondence with global regulatory authorities
- Other duties as assigned

## Qualifications

- Bachelor’s degree with 12+ years of related experience preferably in life sciences with 8+ years of experience in a Clinical Quality Assurance role, or an equivalent combination of PV and QA experience
- Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements
- Broad clinical development experience across all phases (Phase I through BLA/NDA)
- Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages
- Proven experience developing and implementing risk-based clinical quality assurance programs
- Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings
- Skilled at effectively communicating quality events and outcomes to internal stakeholders
- Excellent interpersonal, verbal, and written communication skills (must have)
- Working knowledge of multiple therapeutic areas is a plus
- Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines
- Flexible and creative problem solver with a proactive mindset
- Highly collaborative team player who fosters open communication and cross-functional cooperation
- Willingness to travel up to 20% based on business needs

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $198,000–$225,000, with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

## About Seaport Therapeutics

## Company Overview
- **One-liner**: Seaport Therapeutics is a clinical-stage biotech company developing novel oral prodrugs for depression and anxiety using its proprietary Glyph™ platform to overcome bioavailability and side effect limitations.
- **Entity Type**: Private (clinical-stage; raised $340M in funding across Series A, Series B, and a government grant)
- **Headquarters**: Boston, Massachusetts, United States
- **Founded**: Not publicly available (the company launched as a PureTech Health-founded entity around 2023–2024, based on Series A timing)
- **Founders**: Daphne Zohar (CEO), Michael C. Chen (Co-founder, Chief Scientific Officer); the Glyph platform was co-invented by Jamie Simpson and Dan Bonner of Monash University, who are now part of the team.

## Core Business
- **Primary industry**: Biotechnology / Neuropsychiatric Drug Development
- **Target customers**: Patients with major depressive disorder, generalized anxiety disorder, and other neuropsychiatric conditions; partners and prescribers in psychiatry/neurology
- **Mission or purpose statement**: “Unlocking Better Days™” – developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders.

## Products & Services
- **Glyph™ Platform**: A proprietary oral prodrug technology that enables more medicine to reach the bloodstream and brain while avoiding first-pass liver metabolism and reducing side effects like hepatotoxicity. The platform is licensed exclusively from Monash University.
- **GlyphAgo™ (SPT-320)**: Oral prodrug of agomelatine for Generalized Anxiety Disorder (GAD); Phase 1 proof-of-concept data reported in June 2026 show positive multiple-ascending dose results.
- **GlyphAllo™ (SPT-300)**: Oral prodrug of allopregnanolone for Major Depressive Disorder (MDD); designed to overcome low oral bioavailability and avoid side effects like sexual dysfunction and weight gain.
- **Glyph2BLSD™ (SPT-348)**: Oral prodrug of 2-bromo-LSD, a non-hallucinogenic neuroplastogen for multiple indications including treatment-resistant depression, PTSD, and headache disorders; preclinical stage.

## Market Standing
- **Valuation/Market Cap**: Not disclosed
- **Key Metric**: **Total Funding** – $340M as of March 2026
- **Notable Investors/Partners**:
  - Series A (April 2024): $100M led by Sofinnova Investments and ARCH Venture Partners
  - Series B (October 2024): $225M led by General Atlantic
  - Grant (March 2026): $15M from ARPA-H
  - Corporate round (January 2024): undisclosed investor
  - Strategic collaboration with Monash University (exclusive license for Glyph platform)
- **Growth Signals**:
  - Headcount grew **46.8% YoY** (from ~30 to 52 employees)
  - Positive Phase 1 proof-of-concept data for GlyphAgo (June 2026)
  - Active job postings (5 open roles as of mid-2026)
  - Strong talent inflow from PureTech Health, Karuna Therapeutics, and Bristol Myers Squibb

## Competitive Advantages
- **Proprietary Glyph™ platform** that clinically validates mechanisms previously limited by poor oral bioavailability or liver toxicity (e.g., allopregnanolone, agomelatine, 2-bromo-LSD)
- **Experienced leadership** with deep history in neuropsychiatric drug development (PureTech Health founders, Karuna veterans)
- **First/best-in-class potential** for each pipeline candidate, enabling a pipeline of multiple assets from a single validated platform
- **Worldwide exclusive license** to Monash University’s intellectual property, creating a strong IP moat

## Strategic Focus
- Advance GlyphAgo into Phase 2 trials for GAD
- Progress GlyphAllo and Glyph2BLSD through Phase 1 and toward proof-of-concept
- Expand the pipeline into additional neuropsychiatric indications (TRD, PTSD, headache disorders)
- Continue hiring across clinical development, CMC, biometrics, and program leadership roles

## Why Work Here
- **Mission-driven culture**: Focus on “Unlocking Better Days” for patients with serious mental health conditions
- **Location**: Boston Seaport district (101 Seaport, Boston, MA) – a hub for biotech innovation
- **Growth trajectory**: ~50% headcount growth in the past year signals a rapidly scaling organization with advancement opportunities
- **Team composition**: Small but experienced team (52 employees) with a high ratio of directors/managers (29% director-level), offering exposure to senior leadership
- **Flexibility**: Hybrid/office policy not explicitly stated, but the company has a physical office and lists in-person roles; likely offers flexibility typical of Boston biotechs
- **Culture highlights**: Featured office tour with CEO Daphne Zohar, an emphasis on collaboration and scientific excellence, and strong ties to PureTech Health’s entrepreneurial ecosystem

## Sources
1. [seaporttx.com](https://seaporttx.com/)
2. [seaporttx.com/our-pipeline/](https://seaporttx.com/our-pipeline/)
3. [seaporttx.com/careers/](https://seaporttx.com/careers/)
4. [LinkedIn – Seaport Therapeutics](https://www.linkedin.com/company/seaport-therapeutics)
5. [job-boards.greenhouse.io/seaporttherapeutics](http://job-boards.greenhouse.io/seaporttherapeutics)

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