Senior Director, Innovative Research Methods

AstraZeneca•Gaithersburg, MD

About The Position

Do you have expertise in, and curiosity for driving innovation in evidence generation in Oncology , including introduction of new research methods, data collection approaches or the application of Generative AI to improve operational efficiencies ? Apply your experience to changing the way cancer is treated at AstraZeneca, a company that follows the science and turns ideas into life changing medicines. Help to advance our incredible pipeline by applying expertise and accelerating our pathway to finding a cure. The NextGen Sciences (NGS) team is composed of high ly functional individuals with strong research skills, operating globally across AstraZeneca’s brand and tumour areas to support the broader Evidence Generation to Publications (EG2P) and Global Medical Affairs organizations in the identification of novel approaches for evidence generation , including formation of global data assets, streamlining prospective data collection efforts, and identifying new paradigms for conducting research or generating impactful communication . The Innovative Research Methods (IRM) function is a key component of the NGS team , driving a ‘seed to sprout’ approach for introducing new methods across the broader EG2P organization . The Senior Director , IRM is responsible for : set ting the innovation agenda and identifying methods for downstream operationalization that will improve the quality and turnaround time for clinical studies conducted within EG2P, and the deliver ing impactful digital and patient-focused solutions that support research for the AstraZeneca oncology portfolio . T his role will work collaboratively to identify new opportunities for introducing innovation into our new or ongoing Phase 3b/4 studies, externally sponsored research (ESR ) or Early Access Programmes ( EAPs ) .

Requirements

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

Nice To Haves

Scientific and business expertise in oncology with a strong understanding of key global and regional issues and concerns.
Experience / knowledge of application of GenAI solutions within the medical affairs or evidence generation fields
Familiarity with the latest research and thinking.
Effective problem and conflict resolution skills and validated team focus
Proven track record of operating within cross-functional / matrixed environment, displaying ability to partner with other collaborators / teams.

Responsibilities

Be responsible for multiple initiatives within NGS and EG2P, and therefore must be comfortable with ambiguity and able to flex across different workstreams, cross-functional teams and discussion topics .
Conceive and pilot innovations related to the conduct of clinical studies , including recruitment, data collection, data management or analysis that enhance efficiencies or reduce burden across multiple 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 to ensure consistency and scientific rigor
Inform the development of plans and playbooks that clearly outline key steps for implementation of identified innovations within current workstreams to increase adoption across study teams .
Collaborate closely with internal global cross-functional partners including broader Evidence Generation to Publications (EG2P) team, Oncology Medical Affairs leadership and global Medical teams to enable implementation of new / innovative approaches to data collection, generation or communication .
Outline EG2P’s strategy for innovative digital health or Artificial Intelligence (AI) solutions for evidence generation (including use-cases, risk taxonomy, validation frameworks, etc) and seek opportunities for innovation and simplification .
Be a thought partner in optimiz ing data collection in projects led by EG2P organization, such as Phase 3b/4 studies, ESRs , or where applicable, EAPs , including publication of position papers/guidance and contributions to industry standards
Lead discussions within broader AZ organization, including Research & Development, regarding trends in clinical research innovation.
Provide leadership, mentor, feed forward to teams and individuals to upskill and develop future capabilities in line with AstraZeneca’s dedication to a culture of performance development and lifelong learning.
Lead stewardship of method qualification, evidentiary standards, and regulatory engagement (e.g., dialogues on RWE/external controls, DCT acceptability), ensuring methods meet ICH/GCP and regional expectations before handoff to DIRA

Benefits

Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles.
Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume