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Iambic Therapeutics, a clinical-stage AI-driven drug discovery company founded in 2020, seeks an Associate Director or Director of Clinical Pharmacology to lead clinical pharmacology strategy for oncology small-molecule programs. This role designs and executes PK/PD study strategies, dose selection and optimization, and applies modeling/simulation approaches (PBPK, population PK) to inform development decisions across the pipeline.
You will partner closely with Clinical Development, DMPK, Biostatistics, and Regulatory Affairs to author and review protocols, clinical pharmacology sections of regulatory submissions (IND/IMPD, briefing documents, CTD modules), and prepare responses to health authority queries. You'll contribute to drug-drug interaction, organ impairment, and cardiac safety (QT) assessment strategies, ensuring alignment with FDA/EMA/ICH guidance (including ICH M12). The role may include mentoring junior scientists.
Key responsibilities include representing the Clinical Pharmacology function on multidisciplinary oncology program teams from late-stage discovery through Phase 1 and beyond; independently analyzing and interpreting clinical PK, PK/PD, and exposure-response data; designing clinical pharmacology components of oncology studies (first-in-human dose escalation/expansion, DDI, hepatic/renal impairment, food-effect, cardiac safety, combination-therapy dosing); applying quantitative approaches (PBPK, population PK, exposure-response modeling) to inform dose selection and DDI risk assessment; writing and reviewing regulatory and scientific documentation; and maintaining working knowledge of pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics.
Required qualifications: PhD or equivalent in Pharmacology, Biomedicine, Biochemistry, or related discipline with minimum 5 years of relevant pharmaceutical industry, CRO, or clinical research experience. Proficiency with Phoenix WinNonlin for non-compartmental analysis is required. Highly desirable: clinical development experience with oncology small-molecule therapeutics, including dose-escalation/expansion trial designs and combination-therapy regimens; working knowledge of PBPK modeling and current DDI regulatory frameworks (ICH M12, FDA guidance); hands-on experience with regulatory and scientific documentation writing (protocols, SOPs, SAPs, CSRs); and familiarity with PK bioanalytical methods development and validation. Strong project management, communication, and cross-functional collaboration skills essential.
