Organ Toxicity Expert (Physician) - Hematology - PI
Job Description / Capsule
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
The Hematology-Oncology safety expert leads the AZ Hematology-Oncology Safety Knowledge Group, a multidisciplinary team responsible for evaluation of safety signals and development of proactive and reactive minimization measures related to drug-induced Hematology-Oncology toxicity. In addition, the role holder works as a Senior Physician within Patient Safety (PS).
The Hematology-Oncology safety expert builds a cross-functional multi-skilled team of experts across multi-disciplinary project teams with an aim to interpret potential safety signals, and develop and implement best practices to mitigate risk to patients.
- Provides expert scientific and/or medical input to PS activities, with special focus on cross-project and cross-TA activities of a scientific nature
- Contributes to development of strategies to ensure that scientific assessment, mitigation and prevention of risk to patients are on a leading pharmaceutical industry level
- Contributes to development of scientific methods applied to a wide range of safety data related to Hematology-Oncology toxicity
- Promotes safety science across projects and therapeutic areas
- Provides support, as needed, for discussions with international regulatory bodies
- Contributes to develop better understanding and prevention of Hematology-Oncology safety issues across functions within the company and across Pharmaceutical Companies and Regulatory Authorities.
- Represents AZ on external consortia focused on Hematology-Oncology toxicity
- Contributes to the implementation of the strategy for Superior Patient Safety, and to the successful implementation of the global working model for the Safety Science Section.
- Provides specialist Hematology/Oncology advice to AZ project teams consulting with Hematology-Oncology SKG
- Leads co-ordination of clinical input to Hematology-Oncology SKG work internally and to external initiatives.
- As ab advocate for Hematology-Oncology SKG raises the awareness and impact of the SKG on clinical programmes.
- Contribute to Hematology-Oncology safety biomarker development and preclinical strategies
Education, Qualifications, Skills and Experience
- Specialty training and board certification in Hematology and/or Oncology
- MD background with strong expertise in Hemaotology and/or Oncology, ideally drug-induced Hematology-Oncology injury.
- > 5 years of drug development/safety experience the majority of which should be in industry with clear focus on Hematology-Oncology drug development
- Recognized by peers for therapeutic area expertise and commercial/safety understanding
- Ability to balance business and clinical research objectives
- Experience working with regulatory agencies, preparing regulatory documents and overseeing submissions.
- A thorough knowledge of the pharmaceutical industry, especially clinical research and global regulatory requirements and practices governing expedited and periodic safety reporting, signal generation, safety evaluation and risk management activities
- Proven high quality scientific record
- Demonstrated capability to lead implementation of new technology and/or working routines within a complex organization.
- Excellent verbal and written communication skills
- Experience in leading of cross-functional teams
- Broad knowledge of drug development
- Extensive general medical knowledge
- Strong team-working skills and an ability to work collaboratively in a global pharmaceutical environment
- Strategic thinking
- Strategic influencing
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.