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 Glyph™ 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.

Seaport Therapeutics is seeking someone to lead analytical research and development for its portfolio of small molecule programs targeting neuropsychiatric disorders.  The Senior Director, Analytical R&D, reports to the Vice President, CMC and is responsible for providing strategic and technical leadership for analytical development of small molecules within Seaport’s portfolio, from pre-clinical development to late-stage clinical development. This includes oversight of analytical method development, validation, method transfer to CMO’s, and support of regulatory filings, including investigational new drugs (INDs)/investigational medicinal product dossier (IMPDs) and new drug applications (NDAs). The role also includes strategic partnering with Quality, Development & Manufacturing, and Regulatory to deliver uninterrupted clinical supplies to enable Seaport’s current and future clinical studies.

The role will be accountable for delivering analytical methods that are phase-appropriate and adhere to the highest scientific standards. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, in addition to several years’ experience overseeing analytical development at CMO’s.

The position is responsible for ensuring that all method development, validation and testing (release, stability, and other) performed on behalf of Seaport is conducted in accordance with the appropriate compendial standards, when available, and is compliant to all regulations and industry phase-appropriate testing standards and standard operating procedures.  The Senior Director will also ensure that all testing and testing services coordinate with all other product development activities so that testing does not fall on the critical path and causes product development delays.

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.

Key Responsibilities:

• Serve as the functional head of Analytical Research & Development, accountable for analytical strategy across Seaport’s small‑molecule portfolio from preclinical through late‑stage clinical development.
• Define and implement phase‑appropriate analytical development strategies for drug substance (DS) and drug product (DP), aligned with overall CMC and regulatory objectives.
• Lead and develop the Analytical function within CMC, including direct management of analytical staff and thoughtful planning for future capability needs as the portfolio advances.

• Establish best practices for analytical lifecycle management, data integrity, documentation, and knowledge transfer.
• Define and execute Seaport’s outsourced analytical strategy, including selection, onboarding, governance, and performance management of CDMOs and contract testing laboratories.
• Provide strategic oversight and day‑to‑day governance of CDMO’s, ensuring adherence to scope, timelines, quality standards, and data integrity expectations.
• Provide technical leadership for analytical method development, validation, and transfer for DS and DP, utilizing techniques including (but not limited to) HPLC-CAD, HPLC-UV, GC, LC-MS, LC‑MS/MS, HPLC-FLR, LC-qToF, GC (Residual Solvents), Elemental impurity analysis, IR, qNMR, thermal analysis, droplet size, PSD, lipolysis, and dissolution/ drug release.
• Ensure analytical methods and specifications are scientifically justified, phase‑appropriate, and compliant with applicable compendial standards and regulatory guidelines.
• Review and approve analytical methods, validation protocols, analytical reports, stability protocols, and stability test reports.
• Oversee stability programs, including trending and proactive identification of potential quality or stability issues.
• Collaborate closely with QA, Regulatory Affairs, Development & Manufacturing, Clinical Supply, and Research to ensure alignment across development activities.
• Ensure analytical activities are integrated into overall project plans and do not become a critical path for development timelines.
• Provide analytical CMC leadership for regulatory filings, including INDs, IMPDs, NDAs, and MAAs, with direct responsibility for authoring and reviewing analytical sections.
• Partner with Quality Assurance to support audits of external testing facilities and contribute to Quality and Service Agreements.

Professional Experience/Qualifications:

• MS or Ph.D. in Analytical Chemistry, Physical Chemistry, or a related scientific discipline.
• 12–15+ years of progressive industry experience in small‑molecule analytical development within pharmaceutical or biotechnology organizations.
• Demonstrated experience leading analytical development across multiple development stages, including late‑stage clinical development and registration‑enabling activities.
• Proven experience serving as a functional or sub‑functional leader, including people leadership and accountability for analytical strategy execution.
• Extensive hands‑on expertise in chromatographic and spectroscopic techniques, including GC, LC, IC, chiral separations, and detection methods such as UV/Vis, CAD, MS (SIM/MRM), fluorescence, FID, and ECD.
• Experience managing analytical development and testing activities through CDMOs and contract laboratories in a virtual or highly outsourced operating model.
• Strong knowledge of global regulatory requirements and ICH guidelines applicable to analytical development and control strategies.
• Experience with complex lipophilic drug substances and formulations, including enabling formulation approaches (e.g., SEDDS, soft‑gel dosage forms).
• Demonstrated ability to lead and influence cross‑functional teams in a fast‑paced, resource‑constrained biotech environment.
• Excellent communication, collaboration, and scientific judgment skills, with the ability to make sound decisions balancing speed, quality, and regulatory expectations.
• Willingness to travel internationally approximately 25% of the time.

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 $230,000–$270,000, 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.

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. 

The Role

Seaport Therapeutics is hiring a Director, Biostatistics to serve as the statistical scientific lead for one or more clinical development programs spanning Phase 1–3 within the Biometrics function. Reporting to the VP, Head of Biometrics, this role will provide strategic statistical leadership and serve as an independent statistical authority, shaping development strategies and representing Biostatistics in regulatory interactions, while also performing and guiding hands-on analysis across the clinical portfolio.

In the near term, the role will focus on leading statistical strategy, trial design, and CRO oversight for active clinical programs, ensuring regulatory defensibility and submission readiness. Over time, this leader will help build a strong statistical culture, mentor junior team members, and serve as a key contributor to the Biometrics leadership team as the organization scales.

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 3–4 days per week.

Key Responsibilities

Statistical Scientific Leadership

• Serve as the program‑level statistical lead with end‑to‑end accountability for trial design, analysis, interpretation, and reporting across multiple studies.
• Proactively identify, evaluate, and implement appropriate and innovative statistical methodologies aligned with clinical objectives, regulatory expectations, and risk profile.
• Provide expert judgment on complex statistical issues including multiplicity, missing data, intercurrent events, estimands, sensitivity analyses, and data interpretation.
• Conduct literature review, methodological research, and external benchmarking to support design decisions and defend approaches scientifically.

Clinical Trial Design & Analysis

• Lead the design of clinical trials, including sample size and power calculations; endpoint and estimand strategy (ICH E9(R1)); adaptive, Bayesian, or novel designs where appropriate; and simulation studies to evaluate operating characteristics.
• Translate clinical development questions into statistically sound and efficient designs.
• Author and/or review statistical sections of protocols, SAPs, TFL shells, and clinical study reports, ensuring scientific rigor and regulatory readiness.

Regulatory Strategy & Agency Interaction

• Lead statistical contributions to regulatory interactions (IND/CTA amendments, End‑of‑Phase meetings, Type C, NDA/BLA submissions).
• Prepare and defend statistical approaches in briefing documents, response letters, and meetings with FDA, EMA, and other global health authorities.
• Serve as the statistical lead in addressing regulatory questions, objections, and post‑submission requests, including development of additional analyses as required.

Hands‑On Analysis & Interpretation

• Perform and/or closely guide hands‑on statistical analyses using SAS and R, including ad hoc analyses for safety, efficacy, and decision‑making.
• Ensure analyses are reproducible, traceable, and aligned with agreed‑upon statistical principles.
• Partner with clinical and safety teams to support ongoing data monitoring and signal evaluation.

CRO & Vendor Oversight

• Provide scientific oversight of external CROs and vendors for biostatistics, programming, and data management activities.
• Review and quality‑check SDTM/ADaM datasets, analysis outputs, and define.xml for scientific accuracy and regulatory compliance.
• Ensure end‑to‑end traceability from raw data through analysis and reporting.

Cross‑Functional Collaboration & Influence

• Partner closely with Clinical Development, Regulatory Affairs, Clinical Operations, Pharmacovigilance, and Translational teams.
• Clearly communicate statistical concepts, risks, and recommendations to non‑statistical audiences.
• Mentor junior statisticians and programmers informally; contribute to building a strong statistical culture as the organization scales.

Qualifications

• PhD in Statistics or Biostatistics (or closely related quantitative field with equivalent depth).
• 10+ years of pharmaceutical/biotechnology experience providing biostatistical leadership across clinical development.
• Demonstrated ability to function as a scientific statistical authority, resolving complex design and analysis challenges independently.
• Deep knowledge of regulatory statistical guidance and expectations, including ICH E9, E9(R1), multiplicity, missing data, adaptive designs, and sensitivity analyses.
• Proven experience leading statistical aspects of regulatory submissions and agency interactions.
• Hands‑on expertise in SAS and R, including simulations and advanced analyses.
• Strong understanding of CDISC standards (SDTM, ADaM, Define‑XML) and regulatory traceability.
• Excellent written and verbal communication skills; ability to influence and defend positions with senior stakeholders.
• Experience in CNS/psychiatry or related therapeutic areas is a plus; passion for Seaport’s patient-centric mission is essential.

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. $198,000-$240,000. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

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.

Seaport Therapeutics is seeking a talented and experienced Program Leader (PL) to be an integrative cross-functional leader who is responsible for driving the GlyphAllo Program in order to maximize its future clinical and commercial success in the treatment of depression. This is a highly visible leadership role that bridges scientific, clinical, operational, and commercial disciplines. The GlyphAllo program is currently enrolling a Phase 2b study and the PL will lead the program to execute the current plans within timelines/budget and to plan for future pivotal clinical studies, initial global regulatory filings and pre-commercial activities. He/she will provide leadership across the spectrum of drug development and pre-commercialization activities, ensuring achievement of program and corporate goals. The ideal candidate will be a strategic and entrepreneurial leader well-versed in drug development and commercialization, and a strong influencer who can integrate multiple perspectives effectively and align stakeholders across different functions and levels of the organization.

This position requires a presence in the Seaport area of Boston, with a strong preference for being onsite 4 days per week to foster collaboration and effective leadership as the GlyphAllo program grows in complexity and importance. 

Summary of Key Responsibilities

· Serve as the overall program lead, accountable for end-to-end planning, execution, and delivery of key milestones of clinical studies through NDA submission.

· Work collaboratively and cross-functionally with Research, Nonclinical Development, Clinical Operations, Clinical Research, Regulatory Affairs, Medical Affairs, Manufacturing, Quality Assurance, Drug Safety & Pharmacovigilance, Program Management, Distribution & Supply, Commercial and Finance to deliver on program goals within established timelines and budget.

· Partner closely with Program Management to drive alignment and execution across the cross-functional program team, including development and maintenance of integrated, cross-functional strategic plans, timelines, and budgets; proactive identification of risks; and implementation of mitigation strategies.

· Oversee the development of market research plans to gather deep insights from patients, providers, payers, and other stakeholders. Integrate the insights and other market competitive intelligence into program strategies.

· Integrate cross-functional perspectives, ensuring that program strategy is informed by scientific evidence, clinical data, and the evolving competitive landscape. On an ongoing basis, proactively anticipate issues and ensure contingency plans are put in place; identify barriers and identify solutions to mitigate them; identify opportunities and strategies to capitalize on them.

· Working with functional leaders, ensure that appropriate prioritization and adequate resource allocation (financial and personnel) are present to meet the program timelines and deliverables.

· Maintain a high performing cross-functional program team, monitoring program resourcing, managing conflict, and building team culture; create a positive atmosphere to get the most out of the team.

· Serve as an internal and external ambassador for the program, fostering broad engagement to cultivate strategic KOL relationships and enabling overall integration of external insights to inform program strategies.

· Summarize and represent the program to Seaport leadership, Board of Directors, collaborators, and other external parties, as requested.

Qualifications

· BA/BS degree required; advanced medical, scientific or business degree strongly preferred.

· 10+ years biopharmaceutical development and commercialization experience, with previous demonstrated program leadership responsibilities; demonstrated experience leading cross-functional teams in drug development and pre-commercialization.

· Deep understanding of drug development and global product registration is required, ideally in neuropsychiatry (with preference for experience in depression or anxiety). Commercialization and /or Medical Affairs experience considered a strong plus. Leadership of a recent successful program (positive pivotal data, regulatory approval, etc.) would be ideal.

· Proactive “hands-on” individual with collaborative orientation, who manages teams effectively, is very self-motivated and can smoothly establish strong working relationships within both internal and external organizations. Entrepreneurial problem solver. Achieves goals within timelines and budgets while anticipating and navigating obstacles effectively.

· Initiative and independence to identify short and long-term program needs, creatively formulate plans with team input, efficiently achieve timely decisions/alignment, and organize and deploy resources.

· Exceptional written and verbal communication skills; able to articulate program vision and motivate the team; communicates in an open, direct and timely manner; ensures broader organization is aligned with and aware of the program strategy, status and risks.

· Motivated by patient focus and personal commitment to high performance and results.

· Possesses high integrity and exceptional work ethic.

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 $275,000-$310,000 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.

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 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. For more information, please visit www.seaporttx.com.

Seaport Therapeutics is hiring a Director, Analytical Research and Development, CMC to oversee the analytical method development and phase-appropriate validation of analytical methods for drug substance and drug product in pre-clinical and clinical development. This role reports to the Senior Director, Analytical Research and Development, CMC. In the near term, the role will focus on method development and validation of Phase 1 Phase 2 and early Phase 3 drug substance and drug product candidates.  The role will assist with preparation and review of CMC Regulatory filings. This person will coordinate activities at various CDMO’s to achieve company objectives related to the analytical contribution of process and product development.

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.  Up to 25% travel to CDMO sites will be required.

Key Responsibilities

• Oversee CDMO activites for drug substance and drug product analytical method development, validation and transfer for Seaport Therapeutics as assigned by the Senior Director of Analytical Research and Development
• Represent the analytical CMC function at team meetings with CDMO’s and internal staff.
• Provide strategic oversight and day-to-day governance of assigned CDMO’s including project scope, adherence to timelines, quality, and integrity of data.
• Perform hands-on data review to ensure high-quality data reporting.
• Ensure compliance with regulatory standards, industry guidelines, internal SOPs applicable to the role.
• Support progress at CDMO’s via periodic onsite visits.
• Create and maintain release and stability databases gathered from CDMO stability reports.
• Work with ICH-compliant statistical stability software for stability data trending and shelf life predictions
• Partner cross-functionally with Discovery, Program Teams, Regulatory Affairs, Quality Assurance to support data-driven decision-making and operational excellence at our partner CDMO’s.
• Advise CDMO’s on the analytical tools required to successfully complete method development and validation to industry standards.
• Plan and manage budgets, solicit quotes from vendors, create purchase orders and track spending.

Qualifications

• MS/Ph.D. in Analytical Chemistry or Physical Chemistry and 7+ years in early stage method development, method transfer, method validation for lipophilic drug substances and drug product.
• Demonstrated expertise in analytical development with complex drug substances and drug product formulations
• Experience with drug product formulations utilizing SEDDS in soft-gelatin dosage forms.
• Demonstrated expertise in chromatographic techniques (for example: GC, LC, IC, GC, chiral separations,) employing the following (but not limited to) detectors: UV/vis, CAD, MS (SIM, MRM) fluorescence, FID, ECD.
• Experience with management of CDMO’s for drug substance and drug product for multiple product lines.
• Knowledge of global regulatory requirements, ICH and other relevant guidelines
• Proficiency in the use of Microsoft Office Suite products.
• Excellent communication, collaboration, and leadership skills.
• Comfortable with oversees travel approximately 25% of the time.

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 $198,000-233,000, 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.

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.

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.

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.

Primary Responsibilities

· 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.

Requirements

· 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.

· Occasional work travel as required.

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 at the Executive Director Level is $297,000-$340,000 $the expected salary range for the role at the Vice President Level is $324,000-370,000 with the final title and 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.

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.

Seaport Therapeutics is hiring our first in-house Statistical Programming leader to build and lead the Statistical Programming function within the Biometrics department. Reporting to the VP, Head of Biometrics, this Director will provide strategic oversight of CRO/vendor programming activities, perform hands-on programming in SAS and R, and ensure high-quality, submission-ready deliverables that meet CDISC and global regulatory standards. In the near term, the role will focus on vendor governance, thorough review/QC of datasets and TLFs, and support for regulatory interactions, publications, and ongoing medical/safety monitoring. Longer term, this leader will establish processes and SOPs, recruit and develop a high-performing team, and serve as a key member of the Biometrics leadership team driving continuous improvement.

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.

Key Responsibilities:

• Lead the Statistical Programming function for Seaport Therapeutics; serve as programming representative on study and program teams and within the Biometrics leadership group.
• Provide strategic oversight and day-to-day governance of CROs and external programmers, including scope planning, timelines, quality metrics, and issue escalation.
• Perform hands-on programming in SAS or R to review/QC vendor deliverables, develop analysis datasets (SDTM/ADaM), and generate tables, listings, and figures (TLFs).
• Ensure compliance with CDISC standards (SDTM, ADaM), FDA/EMA/ICH guidance, and submission requirements (e.g., define.xml, reviewer’s guides, eCTD packages).
• Support regulatory interactions (IND, NDA/BLA/MAA), including ad hoc analyses, briefing package outputs, and responses to information requests.
• Partner with Biostatistics, Data Management, Clinical, and Safety to enable medical and safety monitoring, signal detection, and data-driven decision-making across ongoing trials.
• Establish and maintain programming processes, SOPs, work instructions, and reusable libraries/macros; champion automation, reproducibility, and audit readiness.
• Recruit, manage, mentor, and develop a team of statistical programmers as the portfolio grows; manage contractors/FSPs and oversee performance and career development.
• Drive continuous improvement across standards, tools, and infrastructure (SAS/R environments, version control, code review practices) in collaboration with IT and QA.
• Plan and manage resources and budgets for programming activities; contribute to vendor selection, governance frameworks, and performance/quality measures for delivery quality and timeliness.
• Represent Statistical Programming in inspections and audits; ensure documentation completeness and compliance with 21 CFR Part 11, GCP, data privacy, and company SOPs.

Qualifications:

• Advanced degree (MS/PhD) in Statistics, Biostatistics, Computer Science, Mathematics, or related discipline; BS with strong relevant experience considered.
• 10+ years of statistical programming experience in biotech/pharma/CRO settings, with 5+ years of people management.
• Expert hands-on proficiency in SAS (Base, Macro, STAT, GRAPH, SQL) and strong working knowledge of R; experience with Python is a plus.
• Demonstrated experience overseeing CROs/vendors and validating programming deliverables to CDISC standards (SDTM, ADaM).
• Proven contribution to global submissions (e.g., NDA/BLA/MAA), including submission-ready datasets, TLFs, define.xml, reviewer’s guides, and CSR appendices.
• Strong understanding of clinical development processes, ICH/GCP, FDA/EMA guidelines, and 21 CFR Part 11 compliance.
• Track record of building teams, establishing SOPs and standards, and implementing automation and best practices for efficiency and quality.
• Excellent communication, collaboration, and leadership skills; ability to translate technical concepts for non-technical stakeholders.
• Therapeutic area experience in CNS/neuropsychiatry is a plus; passion for Seaport’s patient-centric mission is essential.

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 $198,000-233,000 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.