Your ImpactAs the Director, you will play a central role in developing and executing DMPK and pharmacometrics strategies across our pipeline. You will work at the intersection of DMPK, pharmacometrics, radiopharmaceutical science, and translational development to generate the quantitative insights needed to guide candidate selection, dose and regimen optimization, clinical development, and regulatory strategy.
This is a highly visible, hands-on scientific leadership role within a lean organization. Working closely with the CMO and leaders across R&D, Translational Sciences, Clinical Development, CMC, Regulatory, and external partners, you will help define how quantitative pharmacology and DMPK are applied to the unique challenges of radioligand therapy development.
The right person will bring deep expertise in DMPK and pharmacometrics within RLT, a strong understanding of radiopharmaceutical development, and the scientific judgment to translate complex PK, biodistribution, imaging, and dosimetry data into clear development decisions.
How You'll Contribute- Lead pharmacometrics and quantitative pharmacology strategy across Alpha-9's RLT pipeline from preclinical development 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, dose selection, and clinical decision-making.
- Lead dose-finding, dose and regimen optimization, and quantitative development strategies across FIH, dose escalation, expansion, and later-stage RLT studies.
- Integrate PK, pharmacology, imaging, dosimetry, efficacy, and safety data to inform program strategy, development decisions, and portfolio priorities.
- Provide pharmacometrics and quantitative pharmacology leadership for regulatory submissions and Health Authority interactions supporting RLT programs.
- 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 and fit-for-purpose approaches.
The Skills You Bring- Ph.D. in Pharmacokinetics, Pharmaceutics, Pharmaceutical Sciences, Pharmacology, Chemical Engineering, or a related scientific discipline.
- 10+ years of experience in pharmacometrics, quantitative pharmacology, DMPK, clinical pharmacology, or a related discipline within biotechnology or pharmaceutical organizations.
- Significant, hands-on experience applying pharmacometrics, quantitative pharmacology, or DMPK to radioligand therapy or targeted radiopharmaceutical development is 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 stages of development, including FIH, dose escalation, expansion, and later-stage studies.
- Experience in contributing to RLT regulatory submissions and Health Authority interactions is required.
- Strong scientific understanding of the relationship 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.
- Strong experience with population PK, PK/PD, PBPK, mechanistic modeling, or related pharmacometrics approaches.
- Experience supporting clinical-stage programs, regulatory submissions, and Health Authority interactions.
- Demonstrated ability to lead cross-functional teams, external partners, and complex scientific initiatives.
