- Providing strategic medical and scientific knowledge and supporting design, initiation, execution, completion, interpretation and reporting of clinical studies
- Accountability for medical and ethical components of studies including patient safety on study level in compliance with Good Clinical Practice (GCP) and regulatory requirements
- Delivery of the clinical and scientific components of all relevant study documents (e.g. Protocol, Statistical Analysis Plan, Informed Consent Form)
- Accountability for ensuring safety surveillance on a study level including the process for Adverse Events (AE)/ Serious AE reporting
- Depending on experience, you may work as a GCH delegate across several studies and can be the clinical representative on indication Global Product Team and other sub-teams
- Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent, OR a graduate of a scientific doctorate (e.g. PhD or PharmD) OR equivalent in a scientific discipline or Pharmaceutical Medicine
- 1+ years clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
- Good general medical knowledge in one of our core therapy areas in cardiology, nephrology, liver disease, diabetes, obesity or metabolic diseases, (by specialty training or specific research experience).
- Special interest in chronic kidney disease
- Experience of regulatory submissions
- Excellent English, both spoken and written
- Willing to be office based at our AstraZeneca R&D site in Boston
- Demonstrated 3+ years clinical research expertise in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
- Clinical expertise in one of our core therapy areas, particularly in diabetes, obesity and metabolic disease
- Good understanding of clinical trials methodology, biostatistics, global regulatory environment and pharmacovigilance
- An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence drug development
- An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements
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Medical Director, Late Clinical Development - Boston, United States - AstraZeneca PLC
Description
Medical Director, Late Clinical Development - RenalDo you have expertise in Clinical Research and Development combined with a deep understanding of the medical aspects of drug development and a special interest in chronic kidney disease? Are you ready to apply your expertise in a global company that pushes the boundaries of science with the potential to impact millions of 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.
We are now expanding and offer the opportunity for a Physician to join our Late Cardiovascular, Renal and Metabolism (CVRM) clinical development teams focusing on chronic kidney disease.
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. And there's no better place to learn; from the science, from each other, and from our successes and failures. AstraZeneca is a place of opportunity, with the support you need to thrive and grow.The role is placed at our dynamic R&D site in Boston, Seaport Boulevard, MA, US.
As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026.
Find out more information here:
Kendall Square Press Release
What you'll do
Our therapy area aligned groups of physicians and scientists provide clinical guidance and scientific leadership for clinical development programs within AstraZeneca's global organization.
This is a global role providing medical and scientific expertise in cross functional global teams to develop medicines through design, conduct and reporting of clinical studies within Cardiovascular, Renal, Metabolic, and/or Hepatic Diseases.
In addition to collaborating seamlessly and efficiently with colleagues globally across AstraZeneca R&D, the work involves interactions with external medical experts, Regulatory Authorities, Ethics Committees, Marketing Companies and Investigators/Sites.
You will also maintain a high degree of awareness of new and emerging medical and scientific developments, contribute to publications and present at congresses.
Additional responsibilities include:
With your excellent interpersonal, communication, and collaboration skills you have the ability to operate effectively across boundaries in a global matrix research environment to influence both internal and external stakeholders.
Are you already imagining yourself joining us? Good, because we can't wait to hear from you
Welcome with your application (CV and Cover letter) as soon as possible.
Where can I find out more?
CVRM at AstraZeneca:
Our commitment to advancing CVRM treatment:
Life at AstraZeneca :
Why AstraZeneca?
AstraZeneca is a global, innovation-driven biopharmaceutical company proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration.
Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity.
There's no better place to see what science can do.Date Posted
26-Apr-2024
Closing Date
02-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
