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Alpha-9 Oncology is a clinical-stage biotechnology company developing radiopharmaceutical therapies for solid tumors. The company uses proprietary scaffolds combining optimized binders, linkers, chelators, and radioisotopes to deliver targeted radiation to cancer cells while minimizing harm to healthy tissue.
As Director of DMPK, you will lead the development and execution of drug metabolism and pharmacokinetics (DMPK) and pharmacometrics strategies across the company's radioligand therapy (RLT) pipeline. This is a highly visible, hands-on scientific leadership role reporting to the CMO and collaborating closely with R&D, Translational Sciences, Clinical Development, CMC, Regulatory, and external partners.
Key responsibilities include:
- Lead pharmacometrics and quantitative pharmacology strategy across the RLT pipeline from preclinical through clinical development
- Develop RLT-specific PK/PD, population PK, PBPK, and mechanistic modeling strategies to support candidate selection, translation, and human dose prediction
- Lead quantitative approaches to characterize RLT pharmacokinetics, biodistribution, tissue exposure, target engagement, and exposure-response relationships
- Develop and integrate quantitative PET/SPECT imaging and dosimetry strategies to support absorbed dose assessment and clinical decision-making
- Lead dose-finding, dose and regimen optimization, and quantitative development strategies across first-in-human, dose escalation, expansion, and later-stage studies
- Integrate PK, pharmacology, imaging, dosimetry, efficacy, and safety data to inform program strategy and portfolio priorities
- Provide pharmacometrics and quantitative pharmacology leadership for regulatory submissions and Health Authority interactions
- Lead external quantitative pharmacology, DMPK, imaging, and dosimetry activities with CROs, consultants, and academic collaborators
- Build Alpha-9's RLT quantitative sciences capabilities through scientific leadership, mentoring, and development of innovative approaches
Requirements:
- Ph.D. in Pharmacokinetics, Pharmaceutics, Pharmaceutical Sciences, Pharmacology, Chemical Engineering, or related scientific discipline
- 10+ years of experience in pharmacometrics, quantitative pharmacology, DMPK, clinical pharmacology, or related discipline within biotechnology or pharmaceutical organizations
- Significant, hands-on experience applying pharmacometrics, quantitative pharmacology, or DMPK to radioligand therapy or targeted radiopharmaceutical development (required)
- Deep expertise in PK/PD, population PK, PBPK, mechanistic modeling, exposure-response, and dose optimization
- Demonstrated experience integrating PK, biodistribution, quantitative imaging, and dosimetry into RLT development strategies
- Experience supporting RLT programs across multiple development stages (FIH, dose escalation, expansion, later-stage studies)
- Experience contributing to RLT regulatory submissions and Health Authority interactions (required)
- Strong scientific understanding of relationships between RLT exposure, target engagement, biodistribution, absorbed radiation dose, efficacy, and safety
- Demonstrated ability to lead cross-functional scientific teams and external partners and translate complex quantitative analyses into clear development recommendations
