Callio Therapeutics Inc
Director / Senior Director, Clinical Pharmacology
Callio Therapeutics Inc, Seattle, Washington, us, 98127
Director / Senior Director, Clinical Pharmacology
ABOUT CALLIO THERAPEUTICS Headquartered in Seattle and Singapore, Callio Therapeutics is focused on realizing the promise of multi-payload antibody-drug conjugates (ADCs) to transform cancer patient outcomes. Significantly backed by the industry’s top investors, the company is developing next-generation, multi-payload ADCs that feature differentiated payload and linker technologies to maximize therapeutic benefit by enabling targeted delivery of multi agents to tumor cells. Callio Therapeutics is focused on driving its HER2-targeted dual-payload ADC to the clinic, gathering key clinical data, and progressing its pipeline assets. ABOUT THE ROLE The Director / Sr. Director of Clinical Pharmacology will provide strategic and operational leadership across our pipeline, with a primary focus on clinical pharmacology and biomarker development and implementation in ongoing and planned clinical development. This individual will play a key role in bridging pre-clinical and clinical development, ensuring that drug candidates are advanced with robust scientific rationale, translational insights, and regulatory readiness. KEY RESPONSIBILITIES Lead clinical pharmacology strategy and execution, including PK and ADA method development, PK/PD modelling, clinical sample analysis, dose justification, safety margin assessment, and strategies for patient stratification or dose adjustment Incorporate quantitative endpoints and modelling approaches (PK/PD, exposure–response, biomarker-based) into clinical studies to demonstrate target engagement and pharmacologic mechanism Provide strategic oversight and recommendations on endpoints, study design, safety evaluations, and dose selection across clinical-stage assets Collaborate with biostatisticians to ensure high-quality data analysis, interpretation, and reporting to support internal decision-making Support clinical document preparation, including drafting PK/ADA and exploratory pharmacodynamic assessment plans for clinical protocols Alongside the research team, assist in developing and operationalization of biomarker strategies for patient selection, exploratory pharmacodynamic assessments, mechanism-of-action readouts, and regulatory submissions Contribute to regulatory submissions (draft/review relevant sections for IND, CTA, NDA/BLA) Maintain clear and consistent communication with senior management on clinical pharmacology and translational deliverables, risks, and timelines QUALIFICATIONS Education: Advanced scientific degree in molecular or cancer biology, or a similar field (Ph.D., Pharm.D., M.D.) Experience and skills 8+ years of relevant industry experience in Clinical Pharmacology with 4+ years in a leadership role driving strategy and execution. ADC experience strongly preferred; additional experience with biologics, immunotherapies, or targeted oncology agents is advantageous Demonstrated expertise in clinical pharmacology, including PK/PD modeling, dose selection/justification, safety margin assessment, and immunogenicity/ADA evaluation Experience in translational medicine and biomarker development (desirable) Strong track record of developing and implementing biomarker strategies, including assay development, validation, and incorporation into clinical trials for patient selection and pharmacodynamic assessments Direct experience with regulatory submissions (IND, CTA, NDA/BLA) and participation in health authority interactions Proven ability to work effectively with cross-functional teams (clinical development, regulatory, clinical operations, biostatistics, discovery research, and program management) Excellent strategic thinking skills with ability to translate complex scientific insights into actionable development decisions. Outstanding written and verbal communication skills Strong organizational and project management skills, with demonstrated success managing multiple programs and priorities in fast-paced environments Commitment to mentorship and team development, fostering a collaborative and high-performance culture WHAT CALLIO THERAPEUTICS OFFERS Competitive compensation and comprehensive benefits package Opportunity to work in a dynamic, innovative, and collaborative environment Significantly contribute to potentially groundbreaking therapies for cancer patients
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ABOUT CALLIO THERAPEUTICS Headquartered in Seattle and Singapore, Callio Therapeutics is focused on realizing the promise of multi-payload antibody-drug conjugates (ADCs) to transform cancer patient outcomes. Significantly backed by the industry’s top investors, the company is developing next-generation, multi-payload ADCs that feature differentiated payload and linker technologies to maximize therapeutic benefit by enabling targeted delivery of multi agents to tumor cells. Callio Therapeutics is focused on driving its HER2-targeted dual-payload ADC to the clinic, gathering key clinical data, and progressing its pipeline assets. ABOUT THE ROLE The Director / Sr. Director of Clinical Pharmacology will provide strategic and operational leadership across our pipeline, with a primary focus on clinical pharmacology and biomarker development and implementation in ongoing and planned clinical development. This individual will play a key role in bridging pre-clinical and clinical development, ensuring that drug candidates are advanced with robust scientific rationale, translational insights, and regulatory readiness. KEY RESPONSIBILITIES Lead clinical pharmacology strategy and execution, including PK and ADA method development, PK/PD modelling, clinical sample analysis, dose justification, safety margin assessment, and strategies for patient stratification or dose adjustment Incorporate quantitative endpoints and modelling approaches (PK/PD, exposure–response, biomarker-based) into clinical studies to demonstrate target engagement and pharmacologic mechanism Provide strategic oversight and recommendations on endpoints, study design, safety evaluations, and dose selection across clinical-stage assets Collaborate with biostatisticians to ensure high-quality data analysis, interpretation, and reporting to support internal decision-making Support clinical document preparation, including drafting PK/ADA and exploratory pharmacodynamic assessment plans for clinical protocols Alongside the research team, assist in developing and operationalization of biomarker strategies for patient selection, exploratory pharmacodynamic assessments, mechanism-of-action readouts, and regulatory submissions Contribute to regulatory submissions (draft/review relevant sections for IND, CTA, NDA/BLA) Maintain clear and consistent communication with senior management on clinical pharmacology and translational deliverables, risks, and timelines QUALIFICATIONS Education: Advanced scientific degree in molecular or cancer biology, or a similar field (Ph.D., Pharm.D., M.D.) Experience and skills 8+ years of relevant industry experience in Clinical Pharmacology with 4+ years in a leadership role driving strategy and execution. ADC experience strongly preferred; additional experience with biologics, immunotherapies, or targeted oncology agents is advantageous Demonstrated expertise in clinical pharmacology, including PK/PD modeling, dose selection/justification, safety margin assessment, and immunogenicity/ADA evaluation Experience in translational medicine and biomarker development (desirable) Strong track record of developing and implementing biomarker strategies, including assay development, validation, and incorporation into clinical trials for patient selection and pharmacodynamic assessments Direct experience with regulatory submissions (IND, CTA, NDA/BLA) and participation in health authority interactions Proven ability to work effectively with cross-functional teams (clinical development, regulatory, clinical operations, biostatistics, discovery research, and program management) Excellent strategic thinking skills with ability to translate complex scientific insights into actionable development decisions. Outstanding written and verbal communication skills Strong organizational and project management skills, with demonstrated success managing multiple programs and priorities in fast-paced environments Commitment to mentorship and team development, fostering a collaborative and high-performance culture WHAT CALLIO THERAPEUTICS OFFERS Competitive compensation and comprehensive benefits package Opportunity to work in a dynamic, innovative, and collaborative environment Significantly contribute to potentially groundbreaking therapies for cancer patients
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