Global Development Medical Director – Cardiovascular, Renal, Metabolism
Do you have expertise in Clinical Research and Development combined with a deep understanding of the medical and scientific aspects of drug development? Are you ready to apply your expertise in a global company that pushes the boundaries of science with potential to impact million patients’ lives around the globe? Join us to develop the ground-breaking medicines of the future for Cardiovascular, Renal and Metabolic diseases!
At AstraZeneca, we work without barriers between functions at the cutting-edge of clinical science, it’s a place to rethink the future of medicine to answer some of the most complex unmet patient needs. That’s why we love it – this is the place to make a greater impact!
We are now expanding and offer the opportunity for a Physician to join our Late Cardiovascular, Renal and Metabolism (CVRM) clinical development team. In Late CVRM you will be working cross-functionally in a truly international environment with opportunities to meet and discuss with key opinion leaders, medical and scientific experts as well as commercial and regulatory functions. You will join a team of leading specialists, driven to pursue scientific and clinical knowledge. AstraZeneca is a place of opportunity with the support you need to thrive and grow.
What you’ll do:
As a Global Development Medical Director with a focus on Cardiovascular, Renal or Metabolic diseases (including Diabetes, Obesity and NASH/MASH), you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. You will be responsible for the design, conduct, monitoring, data interpretation and reporting of global clinical trials ensuring that the clinical data collected within the study will allow determination of the benefits and risks of the compound, as well as allow for the intended label indication in markets globally. You will operate according to the highest ethical standards to align with internal SOPs, local regulations, laws, Good Clinical Practice, and regulatory requirements.
Key responsibilities include:
Provide strategic medical and scientific expertise and support the design, initiation, execution, completion, interpretation and reporting of clinical studies
Accountable to deliver medical information, answers, and clarifications to Regulators, Ethics Committees, Marketing Companies, and Investigators/Sites
Accountable for medical and ethical components of studies including patient safety surveillance at the study level in compliance with Good Clinical Practice (GCP) and regulatory requirements
Deliver the clinical and scientific components of all relevant study documents (e.g. Protocol, Statistical Analysis Plan, Informed Consent Form)
Maintain a high degree of understanding and awareness of new and emerging medical and scientific developments, contribute to publications and present at congresses
Collaborate seamlessly and effectively with colleagues across AstraZeneca R&D and with external medical experts, Regulatory Authorities, Ethics Committees, Marketing Companies and Investigators/Sites
Essential for the role:
Graduate of a recognized school of medicine with an M.D. or M.D. PhD degree with specialty or experience in the Cardiovascular, Renal or Metabolism therapeutic areas (including obesity, diabetes, NASH/MASH)
3+ years of pharmaceutical industry experience OR 3+ years of clinical research experience in the academic or clinical practice setting
Demonstrated partnership and collaboration skills, including acting as a leader and effectively communicating across countries and cultures
Fluent in spoken and written English, with good presentation skills and effective communication
Willing to be office based at our AstraZeneca site in Warsaw a minimum of 3 days per week
Desirable for the role:
Clinical research expertise in a relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, and interpreting and reporting trial results
Good understanding of clinical trial methodology, biostatistics, global regulatory environment, and pharmacovigilance
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
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.