Medical / Scientist Director, Clinical Development - Cvrm

AstraZeneca AB / Läkarjobb / Göteborg
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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 or Scientist to join our Late Cardiovascular, Renal and Metabolism (CVRM) clinical development teams. The role will be at Director or Senior Director level depending on your previous experience. 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 positions can be based at either of our dynamic global R&D site in Gothenburg Sweden or Warsaw Poland.

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. You will work closely with the Global Clinical Head (GCH) to develop the medicine to its full potential.

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 on new and emerging medical and scientific development, contribute to publications and present at congresses. Additional responsibilities include:

* 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

Essential for the role

* Medical (M.D.) or Scientific (Ph.D.) degree in relevant area
* Good general medical knowledge preferably in nephrology, cardiology, metabolic diseases, or NASH (by specialty training or specific research experience)
* Significant academic or pharmaceutical industry experience in clinical research
* Excellent English, both spoken and written
* Willing to be office based at one of our AstraZeneca sites in Gothenburg or Warsaw

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.

Desirable for the role

* 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
* 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

So, what's next?

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, no later than January 9th, 2023.

Where can I find out more?

CVRM at AstraZeneca: LINK

AstraZeneca in Gothenburg: LINK

AstraZeneca in Warsaw: LINK

Life at AstraZeneca : LINK

Ersättning
Not Specified

Så ansöker du
Sista dag att ansöka är 2023-01-03
Klicka på denna länk för att göra din ansökan

Arbetsgivarens referens
Arbetsgivarens referens för detta jobb är "R-154068".

Omfattning
Detta är ett heltidsjobb.

Arbetsgivare
Astrazeneca AB (org.nr 556011-7482)

Arbetsplats
AstraZeneca

Kontakt
AstraZeneca
ulrica.marklund1@astrazeneca.com

Jobbnummer
7236606

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