Director, Early Clinical Research

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 outstanding skills with those of people from all over the globe.


Early Respiratory & Immunology (R&I) within AstraZeneca is accountable for the discovery and the development (up to phase III) of new drugs in the R&I arena. Clinical Development within Early R&I consists of experienced medical directors, clinical scientists and clinical program directors, who, in a collaborative manner, define clinical development strategy, design innovative clinical trials and translate novel scientific ideas to proof-of-concept in target populations.

We have current and future opportunities for a Director, Early Clinical Research within the Early R&I Clinical Development Group, in BioPharmaceuticals R&D. The successful candidate will join Early R&I Clinical Development focusing on immunological diseases. This position can be placed either in Gothenburg/Sweden, Cambridge/UK, Warsaw/Poland or Gaithersburg/US.


What you'll do
As a Director, Early Clinical Research you will be a key component of the Project Team, working synergistically with the medical director and clinical team as the expert in medical scientific aspects of the drug and its development during early phase. The nature of this role may require working across projects and diseases.

The key accountabilities will include driving components of the individual clinical programme strategy, as well as the overall concept and design of clinical trials within the Early R&I Clinical Development Team. You will also be the scientific leader with regards to development, interpretation and implementation of new endpoints.

For Immunology at AZ, we work across multiple diseases in specialties focused on Rheumatology (eg, Lupus, rheumatoid Arthritis), GI diseases (eg, Crohns disease, Ulcerative Colitis) and Dermatology (eg, Atopic Dermatitis, Psoriasis).

You will be familiar or become familiar with relevant Regulatory guidelines for drug development for the key immunological diseases, as well as current treatment guidelines, relevant competitor trial designs and data as these are continually evolving. As such this will enable you to build novel and innovative approaches for Early Clinical development, such as Experimental Medicine studies and endpoint data for Go/NoGo decision making.

Additional tasks may include the set-up, design, conduct, reporting and regulatory submission of clinical trials; participation and leadership of cross-functional workstreams within and outside of AstraZeneca. Finally, as a Clinical Scientist you will play a crucial role in leading cross-project activities to direct Early Clinical Development Strategy.

We rely on you to:
* Guide clinical science aspects of the Clinical Development Plans (CDP) and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product claims / profile
* Lead clinical scientific input to the set-up, design (target population, translational biomarker selection and low reference value/target value characterization for decision making), study analysis planning and reporting as well as regulatory submissions
* Initiate and support key contacts with opinion leaders, and help develop alliances as appropriate
* Write and check content and quality of product related publications and input to development of publication strategy
* Follow important developments and trends in the clinical & scientific literature to provide value and direct strategy across Early R&I Clinical Development



Essential for the role
We believe that you hold a Clinical or Biomedical PhD or an MSc/MRes preferably in Immunology and in the setting one of the following: Rheumatology, Gastroenterology or Dermatology. You have several years of clinical drug development, medical affairs or medical research experience within a pharmaceutical company environment. You also possess a degree of specialist knowledge of the medical and scientific activities related to a particular therapeutic area, in this instance, preferably Immunology.

You also possess:
* A good understanding of more than one development function
* Phenomenal interpersonal skills
* Excellent verbal and written communication skills in English
* Ability to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas



So, what's next!
If you are ready to make a difference - apply today, and we'll make it happen together!
We welcome your application no later than December 15, 2021.