Executive Medical Director, Early Clin Dev Oncology Radioconjugat...
AstraZeneca - Watertown, Massachusetts, us, 02472
Work at AstraZeneca
Overview
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Overview
Planning, implementing, and managing the daily operation of assigned drug development projects.
Participating in Discovery extended leadership teams and late-stage steering councils.
Collaborating effectively with key internal and external stakeholders
Contributing to and supporting Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
Examples of typical duties include: Direct/Oversee the design and implementation of early-stage clinical projects, as a member of our Product Development Team (PDT) and leader of the Clinical Sub-Team (CST). Ensure that the overall scientific and medical content of all clinical programs is scientifically and clinically rigorous.
Prepare clinical development plans that integrate pre-clinical and early clinical findings while working to ensure cross-functional alignment on an ongoing basis throughout the early phases of clinical development.
Design scientifically rigorous and maximally cost-effective clinical protocols that are aligned with the clinical development plan.
Present and defend protocols and clinical development plans at internal governance forums.
Serve as Medical Monitor, responsible for the safety monitoring of clinical trials, and as medical expert for Phase I/II studies, managing the process from protocol development thorough individual study report and integrated regulatory documentation.
Provide oversight and guidance to clinical team activities at the Product Development Team, Clinical Study Team, Clinical Trial Team, and Translational Science Sub-Team.
Monitor study progress, ensure proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team.
Present study updates, interim results, and final headline data to senior management as required.
Prepare various official and regulatory documents for Regulatory and other agencies, such as Dossiers, BLAs, INDs, Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy).
Ensure that Serious Adverse Events are properly reported on a global basis.
Lead cross-functional teams comprised of multidisciplinary professionals and clinical scientists. Direct responsibility for leading a team of Clinical Development professionals and ensure delivery of their portfolio of assets.
Implement clinical R&D policies, SOPs and related directives.
Review potential in-licensing candidates and present recommendations to Senior Management groups.
Support any needed due diligence and prepare/present medically sound strategy and plans associated with advanced opportunities.
Contribute and support Department/Clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio.
Required Qualifications: MD or international equivalent is required, Medical Oncology specialty and sub-specialty training is required, Board Certification is preferred.
Clinical or research experience (in an academic or pharmaceutical environment) related to the design and/or conduct of clinical studies in oncology is required.
8+ years of experience in clinical research and/or Oncology drug development in pharmaceutical environment.
Desired Qualifications MD/PhD or equivalent
Credible with key external oncology stakeholders, payers, and oncology scientific communities
Date Posted 31-Jul-2025
Closing Date 01-Aug-2025
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