Director Clinical Pharmacology

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

We are seeking a strategic, hands-on Director, Clinical Pharmacology to serve as the clinical pharmacology scientific lead for one or more development programs spanning Phase 1–3. Reporting to the VP of Clinical Pharmacology, this role will provide strategic leadership and serve as an independent subject matter expert, shaping dose selection, exposure–response strategy, and overall clinical pharmacology plans, while also contributing hands-on analyses across the portfolio. In the near term, the role will focus on leading clinical pharmacology strategy, study design, modeling & simulation, and CRO oversight for active clinical programs, ensuring regulatory alignment and submission readiness. 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:

Clinical Pharmacology Scientific Leadership

• Serve as the program-level clinical pharmacology lead with accountability for strategy across multiple studies and development stages.
• Develop and implement integrated clinical pharmacology plans, including dose selection, dose optimization, and exposure–response characterization.
• Provide expert judgment on complex PK/PD, population PK, bioavailability, drug–drug interactions (DDI), special populations, and QTc strategies.
• Lead interpretation of clinical pharmacology data to inform decision-making and regulatory positioning.
• Conduct literature review, competitive benchmarking, and translational assessments to support development strategy.

Clinical Study Design & Strategy

• Lead the design of clinical pharmacology studies, including:
• First-in-human (FIH) and SAD/MAD studies
• Food effect, bioavailability/bioequivalence
• Drug–drug interaction studies
• QTc and special population studies
• Integrate modeling and simulation (e.g., population PK, PBPK, exposure–response) into study design and decision-making.
• Translate clinical and translational questions into efficient, data-driven development strategies.
• Author and review relevant sections of protocols, clinical pharmacology plans, study reports, and regulatory documents.

Regulatory Strategy & Agency Interaction

• Lead clinical pharmacology contributions to regulatory interactions (IND/CTA submissions, End-of-Phase meetings, NDA/BLA filings).
• Prepare and defend clinical pharmacology strategy, including dose justification and labeling implications, in health authority interactions (FDA, EMA, etc.).
• Respond to regulatory queries and post-submission requests, including additional modeling, simulations, and analyses.

Modeling, Analysis & Interpretation

• Perform and/or oversee PK/PD analyses and modeling and simulation activities (e.g., NONMEM, Monolix, R).
• Ensure analyses are robust, reproducible, and aligned with regulatory expectations.
• Integrate data from clinical, nonclinical, and translational sources to inform development decisions.
• Partner with clinical and safety teams on data interpretation, safety signals, and benefit–risk assessment.

CRO & Vendor Oversight

• Provide scientific oversight of external vendors and CROs supporting clinical pharmacology studies and modeling activities.
• Review datasets, outputs, and reports for scientific rigor, quality, and regulatory compliance.
• Ensure traceability and consistency across analyses and submissions.

Cross-Functional Collaboration & Influence

• Partner closely with Clinical Development, Regulatory Affairs, Biostatistics, Nonclinical, Translational Sciences, and Clinical Operations.
• Communicate complex clinical pharmacology concepts clearly to cross-functional stakeholders.
• Contribute to integrated development strategies and governance discussions.

Qualifications:

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
• 10+ years of relevant industry experience, including demonstrated leadership of clinical pharmacology strategy at the program level.
• Demonstrated ability to serve as a clinical pharmacology lead across clinical development stages.
• Deep expertise in PK/PD, population PK, exposure–response modeling, and model-informed drug development (MIDD).
• Strong knowledge of regulatory guidance and expectations (FDA, EMA; MIDD, DDI, QTc, labeling).
• Proven experience supporting regulatory submissions and agency interactions.
• Hands-on experience with modeling tools (e.g., NONMEM, Monolix, Phoenix NLME, R).
• Excellent communication and leadership skills; ability to influence and defend scientific positions.
• Experience in CNS/psychiatry or related therapeutic area is a plus.
• Passion for advancing patient-focused therapeutics and contributing to a high-impact, collaborative environment.

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 $200,000-$240,000 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.