Senior Director, Innovative Research Methods

Role Summary

Senior Director, Innovative Research Methods responsible for setting the innovation agenda and identifying methods for downstream operationalization to improve the quality and turnaround time for clinical studies within EG2P, and delivering impactful digital and patient-focused solutions that support research for AstraZeneca’s oncology portfolio. Collaborates to identify opportunities for introducing innovation into Phase 3b/4 studies, ESRs, or EAPs.

Responsibilities

• Be responsible for multiple initiatives within NGS and EG2P, and be comfortable with ambiguity across different workstreams and cross-functional teams.
• Conceive and pilot innovations related to the conduct of clinical studies (recruitment, data collection, data management or analysis) to enhance efficiencies or reduce burden across tumour types, geographies and settings.
• Lead external academic partnerships, method co-development (e.g., external control arms, EMR-to-EDC pipelines, synthetic arms, DCT design science), and cross-AZ alignment with R&D Biostatistics, Data Science/ML, and Regulatory.
• Inform development of plans and playbooks outlining key steps for implementation of innovations within current workstreams to increase adoption.
• Collaborate with internal global cross-functional partners to enable implementation of new approaches to data collection, generation or communication.
• Outline EG2P‚Äôs strategy for innovative digital health or AI solutions for evidence generation (use-cases, risk taxonomy, validation frameworks) and seek opportunities for innovation and simplification.
• Be a thought partner in optimizing data collection in EG2P-led projects (Phase 3b/4, ESRs, EAPs), including publication of position papers/guidance and contributions to industry standards.
• Lead discussions within the broader AZ organization regarding trends in clinical research innovation.
• Provide leadership and mentorship to upskill teams and individuals, fostering a culture of performance development and lifelong learning.
• Lead stewardship of method qualification, evidentiary standards, and regulatory engagement (e.g., RWE/external controls, DCT acceptability), ensuring methods meet ICH/GCP and regional expectations before handoff to DIRA.

Qualifications

• MS, PharmD or PhD in relevant scientific subject area (outcomes research, epidemiology, biostatistics).
• Minimum 10 years‚Äô experience in the pharmaceutical industry or consulting with proven track record in clinical operations, clinical development, biostatistics, digital health or related areas.
• Ability to be creative and collaborate on innovative research methods for prospective/clinical studies.
• Proven experience in innovative study approaches (decentralized trials, external control arms, EMR-to-EDC, digital health tools for data collection).
• Recognized as a subject matter authority with deep technical expertise in Phase 3b/4 trials, generation of real-world evidence, and HEOR projects.
• Deep understanding of Good Clinical Practice (GCP) and global regulatory requirements for conducting clinical studies.
• Strong verbal and written communication skills related to clinical research.

Desirable

• Scientific and business expertise in oncology with understanding of global/regional issues.
• Experience/knowledge of GenAI solutions within medical affairs or evidence generation fields.
• Familiarity with the latest research and thinking; effective problem and conflict resolution skills; strong team focus.
• Proven ability to operate in a cross-functional/matrixed environment and partner with diverse teams.