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. As an Assoc Director Physician; Organ Toxicitiy Expert - Renal
in Gaithersburg, MD US, Gothenburg Sweden or Cambridge UK
, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD
(Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.Main Duties and Responsibilities
The Renal safety expert leads the AZ Renal Safety Knowledge Group, a multidisciplinary team responsible for evaluation of safety signals and development of proactive and reactive risk minimization measures related to Renal toxicity. The Renal 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.
In this role you will provide expert scientific and/or medical input to Patient Safety activities, with special focus on cross-project and cross-TA activities of scientific nature. You will contribute to the development of strategies to ensure that scientific assessment, mitigation and prevention of risk to patients are on a leading pharmaceutical industry level. You will contribute to the development of scientific methods applied to a wide range of safety data related to Renal toxicity. You will promote safety science across projects and therapeutic areas. You will provide support, as needed, for discussions with international regulatory bodies. You will contribute to develop better understanding and prevention of Renal safety issues across functions within the company and across Pharmaceutical Companies and Regulatory Authorities. You will represent AZ on external consortia focused on Renal toxicity. You will contribute 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. You will provide specialist Nephrology advice to AZ project teams consulting with Renal SKG. You will lead co-ordination of clinical input to Renal SKG work internally and to external initiatives. You will raise the awareness and impact of the SKG on clinical programmes. You will contribute to Renal safety biomarker development and preclinical strategies.Essential Requirements
- Specialty training and board certification in nephrology
- MD background with strong expertise in nephrology, ideally drug-induced Renal injury.
- 5 + years of drug development/safety experience the majority of which should be in industry with clear evidence of delivery
- 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
Next Steps - Apply today!
- Extensive general medical knowledge
- Strong team-working skills and an ability to work collaboratively in a global pharmaceutical environment
- Strategic thinking
- Strategic influencing
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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MedImmune is the global biologics research and development arm of AstraZeneca