Director, Clinical Pharmacology

Seaport Therapeutics•Boston, MA

3d•Onsite

About The Position

Seaport Therapeutics is seeking a strategic, hands-on Director, Clinical Pharmacology to serve as the clinical pharmacology scientific lead for one or more development programs spanning Phases 1–3. Reporting to the VP of Clinical Pharmacology, the Director will provide strategic leadership and independent subject-matter expertise, shaping dose selection, exposure–response strategy, and clinical pharmacology plans while contributing hands-on 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 position is based in Boston’s Seaport area, with a strong preference for being onsite four days per week. The successful candidate will lead clinical pharmacology strategy across development programs, design studies, apply modeling and simulation, interpret clinical pharmacology data, and contribute to regulatory interactions and submissions. The role includes scientific oversight of CROs and vendors and close collaboration with clinical development, regulatory affairs, biostatistics, nonclinical, translational sciences, and clinical operations. The candidate is expected to communicate complex concepts clearly and contribute to integrated development strategies and governance discussions. Seaport Therapeutics is a clinical-stage therapeutics company developing neuropsychiatric medicines using its proprietary Glyph technology platform. The company describes its culture as collaborative and innovative, emphasizing service to patients impacted by mental health conditions, ownership, entrepreneurial spirit, technical excellence, teamwork, and continuous improvement.

Requirements

PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a 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 FDA and EMA regulatory guidance and expectations, including 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 stakeholders 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.
Lead interpretation of clinical pharmacology data to inform development decisions and regulatory positioning.
Conduct literature reviews, competitive benchmarking, and translational assessments to support development strategy.
Lead design of first-in-human and 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 clinical pharmacology sections of protocols, 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 health authority interactions.
Respond to regulatory queries and post-submission requests, including additional modeling, simulations, and analyses.
Perform and/or oversee PK/PD analyses and modeling and simulation activities.
Ensure analyses are robust, reproducible, and aligned 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 CROs and vendors 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.
Partner with Clinical Development, Regulatory Affairs, Biostatistics, Nonclinical, Translational Sciences, and Clinical Operations.
Communicate clinical pharmacology concepts to cross-functional stakeholders and contribute to integrated development strategies and governance discussions.