Director, Translational Medicine Lead

AstraZeneca • Gaithersburg, MD

4d • Onsite

About The Position

AstraZeneca is seeking an exceptional Director-level Translational Medicine Lead (TML) to join their Haematology R&D organization. This role will have a dedicated focus on B-cell leukemias, specifically B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Chronic Lymphocytic Leukemia (B-CLL). This is a 100% Translational Medicine role, serving as the single point of accountability for biomarker strategy and delivery across a portfolio spanning large molecules (antibody-drug conjugates, bispecific antibodies), small molecules (targeted inhibitors), and cell therapies (CAR-T and next-generation approaches). The Translational Medicine (TM) team transforms hematological cancer biology into actionable insights that drive therapeutic development and clinical decision-making. Operating within the Haematology R&D division, the TM team is the single point of accountability for delivering robust, scientifically driven biomarker strategies to all project teams. The team collaborates closely 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

• short-term incentive bonus opportunity
• equity-based long-term incentive program
• retirement contribution
• commission payment eligibility
• 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