AstraZeneca has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent. Sr. Global Development Medical Director, Heme
We are seeking well-trained physician clinicians with strong leadership skills who are driven by science and the desire to develop novel Immuno-Oncology, Cell Therapy, Anti-body Drug Conjugate, Tumor Driver, DNA Damage Response and Epigenetics therapies for patients with hematological malignancies, and who has a mastery of the drug development process (especially early phase clinical trials), protocol writing & study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. This individual will have the opportunity for growth and development while working in a vibrant environment.
• Leading a team of Clinical Development professionals responsible for delivering against Immuno-Oncology, Cell Therapy, Anti-body Drug Conjugate, Tumor Driver, DNA Damage Response and Epigenetics Drug Development projects in hemato-oncology
• Full responsibility for the planning, implementation and daily operation of assigned drug development projects in early hemato-oncology.
• Collaborate with key internal and external stakeholders and may serve as the project Medical Monitor.
• Contribute to 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.
Specific duties and major responsibilities include:
• Direct/Oversee the design and implementation of early stage clinical hemato-oncology 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.
• MD or international equivalent is required
• Medical hemato-oncology and specialty and sub-specialty training is required, Board Certification is preferred.
• Clinical or research experience (in an academic, pharmaceutical or CRO environment) related to the design and/or conduct of clinical studies in oncology and/or hematology is required.
• Hemato-oncology experience preferred. Cell therapy experience desirable but not critical.
• Director level requires at least 3 years of experience in clinical research and/or Oncology drug development in pharmaceutical or CRO environment.
Working at AstraZeneca
Here you'll have the chance to create a substantial difference to patients' lives! With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines - for the world's most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.
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