Director, Translational OncologyReporting to the VP, Translational Oncology, the Director, Translational Oncology will be responsible for developing and executing translational and clinical biomarker strategies across ALX Oncology's oncology portfolio of early and late stage assets. This individual will work closely with Clinical Development, Clinical Operations, Biometrics, Regulatory, Research, and external partners to translate scientific insights into clinical development strategies, including patient selection, pharmacodynamic and resistance biomarkers, molecular response endpoints, indication selection, and combination strategies.
Preference will be given to candidates who can regularly work onsite Mondays and Tuesdays as part of the company's hybrid work model.
Key Responsibilities include: - Contribute to a culture that reflects ALX's values by acting with integrity, accountability, transparency, and respect. Build strong, collaborative relationships through active engagement with colleagues, including regular onsite participation consistent with the company's hybrid work model.
- Develop and execute translational and clinical biomarker strategies to support oncology development programs, including predictive, pharmacodynamic, and resistance biomarkers, molecular response endpoints, patient and indication selection, and combination strategies.
- Lead the biomarker components of clinical trials, including protocol development and implementation of biomarker, pharmacodynamic, and patient stratification strategies.
- Oversee the selection and management of CROs and laboratory partners, including evaluation of assay and technology platforms, development of scopes of work, data analysis capabilities, and execution of external services.
- Partner closely with Clinical Development and Clinical Operations to integrate scientific and clinical strategy with clinical sample collection, processing, storage, analysis, and data transfer.
- Analyze and integrate biomarker data with clinical endpoints to generate insights that inform clinical development strategy and decision-making.
- Contribute translational and biomarker content to regulatory documents, including Investigator's Brochures, IND submissions, and responses to health authority questions.
- Build productive relationships and collaborations with scientific leaders, key opinion leaders, academic investigators, CROs, and other external partners.
- Contribute to scientific publications and presentations and represent ALX's translational science externally, as appropriate.
- Support other Translational Oncology and organizational priorities as needed.
Preferred Qualifications include: - PhD, MD, or MD/PhD in oncology, cancer biology, molecular biology, immunology, or a related scientific discipline, with approximately 10 years of relevant biotechnology or pharmaceutical industry experience.
- Demonstrated experience supporting oncology drug development from a translational medicine perspective; experience with biologics, immuno-oncology, and antibody-drug conjugate programs preferred.
- Experience developing and implementing translational and clinical biomarker strategies, including acquisition, analysis, and interpretation of biomarker data from clinical trials and integration with clinical endpoints.
- Experience partnering with Clinical Development and Clinical Operations and managing CROs and laboratory partners to support clinical sample collection, handling, analysis, and data transfer.
- Experience with relevant biomarker technologies and assays, which may include immunohistochemistry, digital pathology, flow cytometry, multiplex immunoassays, next-generation sequencing, ctDNA, RNA sequencing, and other molecular profiling approaches.
- Experience analyzing and interpreting large, complex, and/or multi-omic datasets and evaluating associations between biomarkers and clinical outcomes.
- Knowledge of patient-selection biomarker strategies and companion diagnostic development.
- Strong scientific judgment and ability to translate complex biological and clinical data into actionable development strategies.
- Strong communication, collaboration, and relationship-building skills, with the ability to communicate complex scientific concepts clearly and influence cross-functional teams and external partners.
- Demonstrated ability to work independently, prioritize competing demands, solve complex problems, and adapt to evolving program and business needs in a fast-paced, resource-constrained environment.
CompensationThe salary range for this position at our South San Francisco, CA corporate office is $240,000 - $260,000. Additional factors such as academic credentials and relevant experience will influence the actual salary offered. In addition to a competitive market-based salary, ALX Oncology offers the opportunity to participate in stock programs, a performance-based bonus, and a comprehensive benefits package including 401K. Additional information can be found here: https://alxoncology.com/careers/
