Director, Translational Medicine Lead

AstraZeneca • Gaithersburg, MD

5d • $175,498 - $263,248

About The Position

AstraZeneca is seeking an exceptional Director-level Translational Medicine Lead (TML) to join their Haematology R&D organization. This role will focus on B-cell leukemias, specifically B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Chronic Lymphocytic Leukemia (B-CLL). It is a 100% Translational Medicine role responsible for biomarker strategy and delivery across a portfolio of large molecules (antibody-drug conjugates, bispecific antibodies), small molecules (targeted inhibitors), and cell therapies (CAR-T and next-generation approaches). The Translational Medicine team transforms hematological cancer biology into actionable insights that drive therapeutic development and clinical decision-making. They are accountable for delivering robust, scientifically driven biomarker strategies to all project teams and collaborate with preclinical bioscience, clinical development, clinical operations, and Precision Medicine & Biosamples functions. TM provides end-to-end biomarker support from assay development and technical validation through clinical deployment and data interpretation across early- and late-phase studies.

Requirements

• PhD and/or MD with substantive experience in oncology or hematology drug development. MD with clinical training in hematology/oncology is highly valued.
• Minimum 5 years of experience in translational medicine, biomarker science, or clinical development within the pharmaceutical or biotechnology industry.
• In-depth knowledge of B-cell biology, B-cell malignancy disease biology (B-ALL and/or B-CLL), and the therapeutic landscape including approved and investigational agents.
• Demonstrated expertise across multiple therapeutic modalities relevant to B-cell leukemia: large molecules (antibodies, ADCs, bispecifics), small molecules (BTK inhibitors, venetoclax, PI3K inhibitors), and/or cell therapies (CAR-T).
• Proven track record of designing and executing translational biomarker strategies in early- and late-phase clinical trials, including assay development, validation, and clinical deployment.
• Hands-on experience with hematologic biomarker platforms including flow cytometry (immunophenotyping, MRD), molecular diagnostics (NGS, FISH, PCR), and/or IHC/IF for hematologic malignancies.
• Demonstrated ability to drive, manage, execute, and deliver results for complex, multi-functional projects in a matrixed pharmaceutical environment.
• Highly developed problem-solving, critical thinking, and risk management skills with exceptional attention to scientific detail.
• Proven communication, presentation, and influencing skills; ability to translate complex biomarker data into clear, decision-enabling insights for cross-functional audiences.
• Strong collaborative working skills with experience navigating complex multi-stakeholder environments.
• Ability to act as an external ambassador and to influence external organizations to enhance the scientific reputation of AstraZeneca.
• Proven ability to mentor and develop scientific colleagues.

Nice To Haves

• Expertise specifically in both B-ALL and B-CLL, including disease-specific immunophenotyping, minimal residual disease (MRD) monitoring, and clonal evolution dynamics.
• Experience with CAR-T cell therapy programs, including cytokine release syndrome (CRS) monitoring, CAR-T persistence/expansion assays, and antigen escape mechanisms in B-cell malignancies.
• Familiarity with bispecific antibody programs (e.g., CD19xCD3, CD20xCD3) and relevant translational biomarker strategies.
• Hands-on MRD methodology experience (multiparametric flow cytometry and/or NGS-based approaches) and clinical trial deployment in B-ALL and/or B-CLL.
• Experience with CTD/ctDNA platforms and liquid biopsy approaches for monitoring clonal dynamics in leukemia.
• Knowledge of CDx pathways and regulatory expectations (FDA/EMA) for companion diagnostic development in hematologic malignancies.
• Digital pathology and AI/ML integration experience for automated biomarker scoring and image analysis.
• Experience integrating multi-omic biomarkers (flow, NGS, proteomics, cytokines) into clinical decision-making frameworks.
• Publication record in B-cell leukemia biology, translational oncology, or clinical biomarkers.

Responsibilities

• Develop and own comprehensive translational science strategies for B-ALL and B-CLL programs, covering patient selection, pharmacodynamics (PD), mechanism of action (MoA), and mechanism of resistance (MoR) from preclinical through Phase 3 clinical studies.
• Define and execute biomarker plans that deliver robust, decision-quality data to support Go/No-Go (GNG) milestones, dose and schedule selection, and regulatory submissions.
• Apply deep B-cell biology expertise to generate disease-linkage data guiding indication selection and expansion across both B-ALL and B-CLL settings.
• Drive translational strategies across all therapeutic modalities: large molecules (ADCs, bispecific antibodies targeting B-cell antigens such as CD19, CD20, CD22, TSLPR), small molecules (BTK inhibitors, PI3K/BCL-2 pathway agents), and cell therapies (CAR-T, next-generation engineered cell approaches).
• Integrate tumor microenvironment (TME) analyses, immune profiling, and cytokine/immune effector readouts to inform combination strategies and safety/efficacy signals.
• Define and study mechanisms of resistance at relapse, including antigen loss, lineage switching, and clonal evolution, to inform next-line strategies and patient enrichment.
• Lead the identification, development, and analytical validation of fit-for-purpose translational assays, deploying internally and/or via external partners (CROs, academic labs).
• Oversee clinical biomarker implementation: sample collection strategies, laboratory manuals, biomarker sections of clinical study protocols, and statistical/analysis plans for B-ALL and B-CLL studies.
• Integrate flow cytometry, immunohistochemistry (IHC), immunofluorescence (IF), and molecular assays (NGS, ctDNA, MRD panels) to enable patient selection, enrichment, and response monitoring.
• Partner with Precision Medicine & Biosamples on documentation, traceability, CDx pathway considerations, and regulatory expectations for analytical validation.
• Ensure all biomarker data and deliverables meet quality standards for inclusion in clinical study reports, regulatory filings, and scientific publications.
• Serve as the TML representative on B-ALL and B-CLL project teams, collaborating with Oncology Research, Clinical Development, Clinical Operations, and Product Development to integrate translational strategies at every stage of drug development.
• Influence translational strategy across the broader AstraZeneca hematology portfolio, sharing scientific insights and establishing best practices for B-cell malignancy programs.
• Lead and manage internal and external research collaborations, including academic consortia, cooperative groups, and investigator-initiated studies relevant to B-cell leukemia biology.
• Represent AstraZeneca at scientific forums, congresses (ASH, EHA, ASCO), and key opinion leader (KOL) engagements as an external ambassador for the program.
• Contribute to and ensure the quality of TM clinical study reports, data reviews, interpretations, presentations, and recommendations to development teams and senior management.

Benefits

• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree