Associate Director, Clinical Pharmacology – Oncology PK/PD

Iambic Therapeutics, Inc.; San Diego, Northern (CA, KY); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Competitive pay

Company-paid healthcare

Flexible spending accounts

Life insurance

401K matching

Uncapped vacation

Job summary

Iambic Therapeutics is seeking an Associate Director/Director of Clinical Pharmacology to lead the PK/PD strategy for oncology small-molecule programs. You will design dose selection, oversee model-based analyses, and guide DDI, organ impairment, and cardiac safety assessments in alignment with FDA/EMA guidelines.

You will collaborate with Clinical Development, DMPK, Biostatistics, and Regulatory Affairs to draft protocols and regulatory submissions, mentoring junior scientists and ensuring

Qualifications

• PhD or equivalent in Pharmacology/Biomedicine/Biochemistry or related discipline with minimum 5 years in pharma/clinical research.
• Experience in oncology small-molecule development including dose-escalation/expansion and combination therapies.
• Proficiency with Phoenix WinNonlin for non-compartmental analysis.
• Knowledge of PBPK, DDI regulatory frameworks (ICH M12, FDA guidance).
• Experience in regulatory/scientific documentation: protocols, SAPs, CSRs.

Responsibilities

• Represent Clinical Pharmacology on multi-disciplinary oncology teams from discovery through Phase 1 and beyond.
• Analyze, interpret and report PK/PK-PD data for oncology assets.
• Design pharmacology components of studies including DDI, hepatic/renal impairment, food effects, and QT studies.
• Apply quantitative modeling (PBPK, population PK, exposure-response) to inform dosing and DDI risk.
• Prepare and review regulatory documents and publications.

Skills

Pharmacology knowledge

Regulatory collaboration

Cross-functional teamwork

Data analysis

Education

PhD in Pharmacology/Biomedicine/Biochemistry or related

Tools

Phoenix WinNonlin

PBPK modeling

SimCyp

NONMEM

R

Job description

Iambic Therapeutics is seeking an Associate Director/Director of Clinical Pharmacology to lead the PK/PD strategy for oncology small-molecule programs. You will design dose selection, oversee model-based analyses, and guide DDI, organ impairment, and cardiac safety assessments in alignment with FDA/EMA guidelines.

You will collaborate with Clinical Development, DMPK, Biostatistics, and Regulatory Affairs to draft protocols and regulatory submissions, mentoring junior scientists and ensuring