Director, Clinical Pharmacology — PK/PD Strategy & Modeling

Seaport Therapeutics; Boston (MA); Presencial; USD 200.000 - 240.000; Tempo integral

Resumo da vaga

Seaport Therapeutics in Boston seeks a Director of Clinical Pharmacology to serve as the clinical pharmacology scientific lead across Phase 1–3 programs. You will shape dose selection, exposure–response, and regulatory strategy, while guiding hands-on PK/PD analyses and CRO oversight.

The role reports to the VP of Clinical Pharmacology and emphasizes collaboration, entrepreneurial spirit, and a focus on CNS/psychiatry therapies.

Qualificações

• PhD, PharmD, or MD in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or related discipline.
• 10+ years of industry experience, including leadership of clinical pharmacology strategy at program level.
• Experience leading pharmacology strategy across development stages and regulatory submissions.

Responsabilidades

• Lead clinical pharmacology strategy for multiple studies across PHI-3.
• Design and interpret PK/PD analyses, exposure–response, and modeling.
• Oversee CROs and external vendors for pharmacology studies.
• Interact with regulators (FDA/EMA) for submissions and inquiries.
• Collaborate with cross-functional teams to inform program decisions.

Conhecimentos

Strategic leadership

Clinical pharmacology

Regulatory strategy

PK/PD modeling

Model-informed drug development

CNS/psychiatry experience

Formação

PhD in Clinical Pharmacology

PharmD

MD

Ferramentas

NONMEM

Monolix

Phoenix NLME

R

Descrição da vaga

Seaport Therapeutics in Boston seeks a Director of Clinical Pharmacology to serve as the clinical pharmacology scientific lead across Phase 1–3 programs. You will shape dose selection, exposure–response, and regulatory strategy, while guiding hands-on PK/PD analyses and CRO oversight.

The role reports to the VP of Clinical Pharmacology and emphasizes collaboration, entrepreneurial spirit, and a focus on CNS/psychiatry therapies.