Director, Clinical Pharmacology

The role

The Director, Clinical Pharmacology serves as the scientific lead for development programs spanning Phase 1–3. This role shapes dose selection, exposure–response strategy, and clinical pharmacology plans while providing hands-on analyses.

What you will do

• Serve as the program-level clinical pharmacology lead for multiple studies and development stages.
• Develop and implement integrated clinical pharmacology plans including dose selection and exposure–response characterization.
• Provide expert judgment on PK/PD, population PK, bioavailability, drug–drug interactions, special populations, and QTc strategies.
• Lead the design of clinical pharmacology studies including FIH, SAD/MAD, food effect, and DDI studies.
• Integrate modeling and simulation into study design and decision-making.
• Author and review protocols, clinical pharmacology plans, study reports, and regulatory documents.
• Lead clinical pharmacology contributions to regulatory interactions and submissions.
• Perform or oversee PK/PD analyses and modeling and simulation activities.
• Provide scientific oversight of external vendors and CROs.
• Partner with Clinical Development, Regulatory Affairs, Biostatistics, Nonclinical, Translational Sciences, and Clinical Operations.

Required qualifications

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
• 10+ years of relevant industry experience.
• 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.

Nice to have

• Experience in CNS/psychiatry or related therapeutic area

About the company

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines using its proprietary GlyphTM technology platform.