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About the Role
The Director, Translational Oncology will develop and execute translational and clinical biomarker strategies across ALX Oncology's oncology portfolio. This role involves translating scientific insights into clinical development strategies, including patient selection, pharmacodynamic and resistance biomarkers, and combination strategies.
Responsibilities
- 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.
Requirements
- 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.
Skills
- Translational Oncology
- Biomarker Strategy
- Clinical Development
- Oncology Drug Development
- Biologics
- Immuno-oncology
- Antibody-Drug Conjugate Programs
- Biomarker Technologies
- Assay Development
- Immunohistochemistry
- Digital Pathology
- Flow Cytometry
- Multiplex Immunoassays
- Next-Generation Sequencing
- ctDNA Analysis
- RNA Sequencing
- Molecular Profiling
- Data Analysis
- Clinical Endpoints
- Regulatory Documents
- Investigator's Brochures
- IND Submissions
- Health Authority Questions
- Scientific Leadership
- Key Opinion Leader Engagement
- Academic Collaboration
- CRO Management
- Laboratory Partner Management
- Scientific Publications
- Scientific Presentations
- Communication Skills
- Collaboration Skills
- Relationship-Building Skills
- Problem-Solving
- Adaptability
Location
- South San Francisco, CA
Work Type
- Hybrid
Experience Level
- Director
- Approximately 10 years of relevant biotechnology or pharmaceutical industry experience
Education Level
- PhD, MD, or MD/PhD in oncology, cancer biology, molecular biology, immunology, or a related scientific discipline
Salary/Compensations
- $240,000 - $260,000
Benefits
- Stock programs
- Performance-based bonus
- Comprehensive benefits package including 401K
About the Company
- ALX Oncology (Nasdaq: ALXO) is a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives.
- ALX Oncology's lead therapeutic candidate, evorpacept, has demonstrated potential to serve as a cornerstone therapy upon which the future of immuno-oncology can be built.
- Evorpacept is currently being evaluated across multiple ongoing clinical trials in a wide range of cancer indications.
- ALX Oncology’s second pipeline candidate, ALX2004, is a novel EGFR-targeted antibody-drug conjugate with a differentiated mechanism of action.
- A Phase 1, dose-escalation trial of ALX2004 is ongoing in patients with EGFR-expressing solid tumors.
- More information is available at www.alxoncology.com and on LinkedIn @ALX Oncology.
Equal Opportunity
- ALX Oncology does not accept unsolicited resumes or candidate information from recruitment agencies, including blinded or anonymized resumes, and will not be responsible for any fees associated with unsolicited submissions.
- Do not contact hiring managers or other ALX Oncology employees directly.
- Recruiting activities are managed through our Human Resources team.