Director, Clinical Pharmacology

Seaport Therapeutics•Boston, MA

4d•$200,000 - $240,000•Onsite

About The Position

Seaport Therapeutics is a clinical-stage therapeutics company developing neuropsychiatric medicines using its proprietary Glyph technology platform. The Director, Clinical Pharmacology will serve as the clinical pharmacology scientific lead for one or more development programs spanning Phases 1–3. Reporting to the VP of Clinical Pharmacology, this strategic, hands-on role will shape dose selection, exposure–response strategy, and clinical pharmacology plans while contributing analyses across the portfolio. Near-term priorities include clinical pharmacology strategy, study design, modeling and simulation, and CRO oversight for active clinical programs, with a focus on regulatory alignment and submission readiness. The role is based in Boston’s Seaport area, with a strong preference for onsite work four days per week. The successful candidate will contribute to a collaborative, innovative culture focused on patients affected by mental health conditions, taking ownership, demonstrating entrepreneurial spirit and technical excellence, and fostering teamwork and continuous improvement.

Requirements

PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a related discipline.
10 or more 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, including FDA and EMA guidance related to MIDD, DDI, QTc, and labeling.
Proven experience supporting regulatory submissions and agency interactions.
Hands-on experience with modeling tools such as NONMEM, Monolix, Phoenix NLME, or R.
Excellent communication and leadership skills, including the ability to influence and defend scientific positions.

Nice To Haves

Experience in CNS/psychiatry or a related therapeutic area.
Passion for advancing patient-focused therapeutics and contributing to a high-impact, collaborative environment.

Responsibilities

Serve as the program-level clinical pharmacology lead 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 PK/PD, population PK, bioavailability, drug–drug interactions, special populations, and QTc strategies.
Interpret clinical pharmacology data to inform decisions and regulatory positioning.
Conduct literature reviews, competitive benchmarking, and translational assessments to support development strategy.
Lead the design of first-in-human, SAD/MAD, food effect, bioavailability/bioequivalence, drug–drug interaction, QTc, and special population studies.
Integrate modeling and simulation, including population PK, PBPK, and exposure–response, into study design and decision-making.
Translate clinical and translational questions into efficient, data-driven development strategies.
Author and review protocols, clinical pharmacology plans, study reports, and regulatory documents.
Lead clinical pharmacology contributions to IND/CTA submissions, End-of-Phase meetings, and NDA/BLA filings.
Prepare and defend clinical pharmacology strategy, including dose justification and labeling implications, in interactions with health authorities such as the FDA and EMA.
Respond to regulatory queries and post-submission requests with additional modeling, simulations, and analyses.
Perform and/or oversee PK/PD analyses and modeling and simulation activities.
Ensure analyses are robust, reproducible, and consistent with regulatory expectations.
Integrate clinical, nonclinical, and translational data to inform development decisions.
Partner with clinical and safety teams on data interpretation, safety signals, and benefit–risk assessment.
Provide scientific oversight of external vendors and CROs supporting clinical pharmacology studies and modeling.
Review datasets, outputs, and reports for scientific rigor, quality, and regulatory compliance; ensure traceability and consistency across analyses and submissions.
Partner with Clinical Development, Regulatory Affairs, Biostatistics, Nonclinical, Translational Sciences, and Clinical Operations.
Communicate complex clinical pharmacology concepts clearly to cross-functional stakeholders and contribute to integrated development strategies and governance discussions.