Study Physician Haematology
6 days left
- Full Time
At AstraZeneca, we are driven by science, united by science, and every day, we push the boundaries of science to deliver life-changing medicines.
With one of the largest pipelines in the industry — including more than 120 research projects and product candidates AstraZeneca stands as one of the world’s outstandings biotechnology companies, our mission is centered on delivering products that advance world health and help fight and cure disease. If you’re passionate about the possibilities of science to change lives and you thrive when making decisions – join us.
We’re constantly pushing the boundaries of science to deliver medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering research and exploring novel pathways across therapeutic areas including oncology, hemato-oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer an outstanding and strong collaborative network as part of the AstraZeneca family, as together we explore alliances between small and large molecules.
AstraZeneca has a dynamic environment that cultivates collaboration and innovation. We attract top minds, and we champion and build top talent.
Position Summary: We are seeking well-trained 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 proficiency in 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 partners 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/Coordinate 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 thorough.
- 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 thorough and maximally efficient 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 specialist for Phase I/II studies, innovating the process from protocol development through individual study report and coordinated regulatory documentation.
- Provide oversight and mentorship to clinical team activities at the Product Development Team, Clinical Study Team, Clinical Trial Team, and Translational Science Sub-Team.
- Monitor study progress, ensure accurate 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 sophisticated clinical development issues (e.g., safety or efficacy).
- Ensure that Serious Adverse Events are accurately reported on a global basis.
- Lead cross-functional teams comprised of multidisciplinary professionals and clinical scientists. Direct responsibility for developing 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 sophisticated 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 crafted to optimally 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.
- Welcome backgrounds that include, Industry (Pharma), CRO, Academia/Research
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