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Senior Medical Director
hace 3 semanas
**Location**
US: Boston or Gaithersburg, MD
Spain: Barcelona
Sweden: Gothenburg
Are you an experienced drug developer with expertise in immunology, rheumatology or inflammatory bowel disease? Would you like to be a part of a talented and high performing team of clinical research professionals, clinical scientists and physicians who are translating scientific discoveries into early phase clinical development plans and clinical studies across a wide range of diseases?
This role will be located at one of our Global Research and Development strategic sites, in the US, Spain or Sweden.
At AstraZeneca, we’re dedicated to being a Great Place to Work with an inclusive and diverse team who work in a solution-oriented, trusting, and collaborative work environment. We are dedicated to improving the health care and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies that address unmet clinical needs and provide clinicians with novel evidence-based treatment options to optimize the care of their patients.
**Who We Are**
In the Respiratory and Immunology Early Clinical Development team, we are investigating the drivers of key respiratory and immunology diseases, with access to cutting edge science, innovative drug discovery approaches and key collaborations with academic centers around the world. We are investigating a wide range of different drug modalities - small molecules, biologics, oligonucleotides and cell therapies - across multiple diseases with high unmet medical need.
Early Clinical Development, part of the Early R&I organization, is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies (Phase 1 - Phase 2b), while collaborating closely with our late phase clinical development colleagues who guide our phase 3 clinical studies. We are a diverse team of experienced physicians and clinical scientists who collaborate with scientists and translational medicine colleagues to define our early phase clinical development strategies, design innovative phase 1-2b clinical trials, develop and validate new clinical endpoints and translate scientific ideas to proof-of-concept studies in targeted patient populations.
We are recruiting for a Senior Medical Director (physician) and/or Senior Director (clinical scientists). In this role, you will have the opportunity to work at the forefront of early clinical and translational research within immunology at AZ. In a multidisciplinary environment, you will play a key role in progressing a rich and diverse pipeline in numerous active clinical programs.
**What You Will Do**
You will be responsible for managing and contributing to early phase I-IIb global clinical trials and related clinical research projects for compounds that are targeting immunology indications ranging from SLE and RA to IBD, as well as serving as an expert on the design, conduct, monitoring, data interpretation, and reporting of these studies. Additionally, you will work on cross-functional teams within our ECD group and across the broader early R&I organization that are framing our strategies and development plans for compounds that are a range of indications, including asthma, COPD and additional immunology indications.
You will take responsibility for clinical development in cross-functional teams to support early phase clinical development activities. These activities include the creation of overall clinical development plans and clinical study design as well writing protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies, all in close collaboration with relevant internal and external partners and clinical research organizations.
**Responsibilities**
- Responsible for the design, delivery and interpretation of clinical studies from first-in human through Ph2b, ensuring compliance with GCP and ethical / scientific integrity of studies
- Lead ongoing monitoring of clinical data to ensure quality and safety, including SAE/SUSAR/protocol deviations and periodic review of emerging safety data by SRC/DMCs, and oversee the support of investigational sites on protocol related matters and investigation of unexpected trends in data
- Lead clinical development strategy from early target identification through Phase 2b (with senior support as necessary) and secure cross-functional alignment across wider AZ organization
- Provide clinical development /disease expertise to Research, Translational Medicine, Early and Late-stage Clinical Development and Commercial colleagues as part of a cross functional teams
- Closely follow medical developments within the autoimmune / inflammatory diseases and disseminate new information within Clinical Development and the wider organization to transform trends and emerging data into agile and innovative clinical plans.
- Represent Early R&I Clinical Development at internal governance interaction
