Director, Oncology Bioanalytical Strategy Lead

AstraZeneca • Cambridge, MA

4d • $175,498 - $263,248 • Onsite

About The Position

As part of AstraZeneca’s Integrated Bioanalysis (IBA) Global Team, the Director, Oncology Bioanalytical Strategy Lead designs and implements bioanalytical strategies—including pharmacokinetic, immunogenicity, and biomarker endpoints—to support the company’s pipeline, with a focus on oncology. The role serves as IBA project lead for selected programs, providing scientific oversight and ensuring assays are developed, validated, and implemented in line with their intended context of use. This includes close collaboration with internal scientific and technical laboratory staff, project teams, stakeholders, and external laboratories and CROs.

The position is based at one of AstraZeneca’s U.S. research hubs in Gaithersburg, Maryland, or Boston, Massachusetts. The role works with teams across Clinical Pharmacology and Safety Sciences, Translational Medicine, Research, and Clinical Development, and coordinates with bioanalytical leads, CROs, study management, IBA leadership, and other functions to deliver high-quality, timely bioanalytical support. The successful candidate will help align stakeholders on strategies and deliverables, manage expectations, contribute to project strategy and delivery, and support multiple modalities, including antibody-drug conjugates, radioconjugates, biologics, cell therapies, and small-molecule products.

The role also supports regulatory submissions and responses to health authorities across countries and geographies. As a subject matter expert, the Director contributes to IBA’s scientific reputation through presentations and publications, fosters scientific knowledge exchange, and participates in strategic initiatives to advance IBA as a scientific leader and strategic partner. The role includes line and matrix management responsibilities, including coaching and mentoring senior bioanalytical leads.

Requirements

• Bachelor’s degree in immunology, molecular biology, or related studies and at least 10 years of relevant experience, or a master’s degree in those fields or related studies and at least 7 years of relevant biopharmaceutical industry experience.
• Proven subject-matter expertise in regulated bioanalysis across modalities, including pharmacokinetic, pharmacodynamic, and humoral and cellular immunogenicity assessments.
• Experience in regulated bioanalysis and in-depth knowledge of complex biologics and/or bioanalysis of antibody-drug conjugates and related modalities.
• Experience as a bioanalytical lead in diverse project teams, defining, leading, and implementing robust strategies to advance a portfolio.
• Experience working with stakeholders to solve challenges and mitigate risk.
• Ability to assess analytical approaches, including ligand-binding assays, LC-MS, molecular assays such as ddPCR, qPCR, and RT-qPCR, flow cytometry, ELISpot, viral assays, and cytokine assays.
• Experience with assay transfer, scientific quality, and CRO study conduct, as well as data analysis and interpretation and delivery of preclinical and clinical data to project teams.
• Deep understanding of global regulatory expectations and guidance in relevant areas.
• Experience contributing to regulatory submissions such as INDs, CTAs, IBs, ISIs, and/or NDAs/BLAs, and responding to regulatory authorities across multiple geographies.
• Ability to interpret integrated and complex datasets.
• Ability to manage concurrent projects or tasks, prioritize, and manage resources in a fast-paced environment.
• Line and matrix management experience, including ability to coach and mentor senior bioanalytical leads.
• Background in pharmaceutical clinical trial research.
• Proven record of publications and presentations.
• Exceptional verbal and written communication skills.
• Experience serving as a project representative, working with stakeholders, and understanding the drug development process and regulatory filings.

Nice To Haves

• Experience supporting antibody-drug conjugates, radioconjugates, or T-cell engagers in addition to traditional biologics.
• Experience with radioconjugates, cell therapy, and/or small molecules.
• Strong scientific background in immunology and ability to support drug programs across multiple therapeutic areas.
• Deeper expertise in flow cytometry.
• Experience partnering with bioanalysis operational functions, clinical operations, and external CROs to develop efficient processes for bioanalytical execution.

Responsibilities

• Design and implement robust bioanalytical strategies, including pharmacokinetic, immunogenicity, and biomarker endpoints, to support the AstraZeneca pipeline.
• Serve as IBA project lead for selected programs and lead bioanalytical strategy, assay design, scientific oversight, and delivery.
• Work with IBA scientific and technical laboratory staff, cross-functional stakeholders, internal and external laboratories, and CRO partners to develop, validate, transfer, and implement assays.
• Provide scientific oversight and delivery for the Oncology portfolio across multiple modalities, including antibody-drug conjugates, radioconjugates, biologics, cell therapies, and small-molecule products.
• Engage project teams and stakeholder functions to develop holistic strategies, gain alignment on deliverables, manage expectations, and mitigate project risk.
• Oversee CRO partner assay transfer, scientific quality, and study conduct; interpret data and deliver preclinical and clinical findings to project teams.
• Work with regulatory agencies and health authorities across countries and geographies, support regulatory documents, and respond to health authority questions.
• Contribute to regulatory submission documentation, including INDs, CTAs, IBs, ISIs, and/or NDAs/BLAs.
• Interpret integrated and complex datasets and contribute to project strategy and delivery.
• Present at internal and external meetings and publish manuscripts.
• Contribute to strategic initiatives supporting the continued evolution of IBA.
• Foster scientific knowledge exchange and collaborate with stakeholders and cross-functional project teams.
• Coach and mentor senior bioanalytical leads and manage line and matrix responsibilities.
• Partner with operational functions, clinical operations, and external CROs to support efficient bioanalytical execution.

Benefits

• Qualified retirement program (401(k) plan)
• Paid vacation and holidays
• Paid leaves
• Medical coverage
• Prescription drug coverage
• Dental coverage
• Vision coverage
• Short-term incentive bonus opportunity
• Eligibility to participate in the equity-based long-term incentive program for salaried roles

What This Job Offers

• Job Type: Full-time
• Career Level: Director