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AstraZeneca · 1 day ago

Senior Director, Innovative Research Methods

Gaithersburg, MD

Full-time

Onsite

Director/Executive

$229K/yr - $344K/yr

10+ years exp

AstraZeneca is a company that follows the science and turns ideas into life changing medicines. The Senior Director, Innovative Research Methods will be responsible for setting the innovation agenda in evidence generation for oncology, leading multiple initiatives, and collaborating with cross-functional teams to enhance efficiencies in clinical studies.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

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 optimizing 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

Qualification

Clinical operationsBiostatisticsDigital healthOncology expertiseGenerative AIClinical PracticeProblem resolution skillsCommunication skillsTeam collaboration

Required

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

Preferred

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

Benefits

Qualified retirement programs

Paid time off (i.e., vacation, holiday, and leaves)

Health, dental, and vision coverage in accordance with the terms of the applicable plans

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)