Director, Early Clinical Research
AstraZeneca AB / Biomedicinjobb / Göteborg
2025-03-18
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hela Sverige Are you ready to make a significant impact in the world of drug development?
This is an excellent time to join a team of clinical researchers, clinical scientists and physicians who are translating scientific discoveries into early phase clinical development plans and clinical studies across a wide range of diseases.
The position as Director, Early Clinical Research is placed at AstraZeneca's vibrant R&D site in Gothenburg, Sweden where you will be part of an international, open-minded and creative working atmosphere based on collaboration and innovation.
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 pioneering science, innovative drug discovery approaches and key collaborations with academic centers around the world. We are investigating a wide range of drug modalities - small molecules, biologics, oligonucleotides and cell therapies - across multiple diseases with high unmet medical need.
Early Clinical Development in R&I is where science meets clinical drug development with a focus upon delivering innovative, early phase clinical studies (Phase 1 - Phase 2), 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 1-2 clinical trials, develop and validate new clinical endpoints and translate scientific ideas to proof-of-concept studies in targeted patient populations.
What You Will Do
You will contribute to early Phase I-2 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 being developed for a range of indications, including asthma, COPD and additional immunology indications.
You will contribute to the clinical development of molecules in cross-functional teams to support early phase clinical development activities. These activities include supporting the creation of overall clinical development plans and clinical study design and contributing to the writing of clinical study protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies, all in collaboration with relevant internal and external partners and clinical research organizations.
Qualifications that apply to the role:
* Advanced degree in relevant scientific subject area (PhD, MD, or PharmD). Experience in gastroenterology / inflammatory bowel disease and/or research training in immunology or cell therapy is a plus.
* Minimum of 2 years of experience in early phase clinical development. Experience in the design, delivery and interpretation of Ph1 / Ph2 studies in relevant non-oncology indications is a plus.
* Experience in the authoring of relevant regulatory documents, including INDs, protocols, ICFs, PIPs, briefing books as well authoring responses to HAs / ECs and site queries is desirable
* An understanding of the entire drug development process, including clinical and non-clinical study design and execution, and clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and clinical development plans with clear data-driven decision rules.
* An understanding of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies.
* Attention to detail, internal drive to generate high-quality work and sense of passion and urgency to achieve team and program goals.
* Demonstrated experience managing complex projects and working collaboratively with multiple stakeholders.
* Outstanding communication skills.
* Excellent analytical, problem solving and strategic planning skills.
* Ability to thrive in a fast-paced environment.
So, What's Next?
Please send in your application in English, including your CV and cover letter, no later than March 31st.
Where can I find out more?
AstraZeneca Gothenburg site:
https://www.astrazeneca.com/our-company/our-locations/gothenburg.htmlLife in Gothenburg:
https://www.astrazeneca.se/om-oss/verksamheten-i-sverige/goteborg/relocate-to-gothenburg.htmR&I at AstraZeneca:
https://www.astrazeneca.com/our-therapy-areas/respiratory-and-immunology.htmlWhy AstraZeneca?
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.
At AstraZeneca, we are dedicated to being a Great Place to Work. Our team is inclusive and diverse, working in a solution-oriented, trusting, and collaborative work environment. We are committed to improving healthcare and quality of life for patients across a wide range of diseases and disorders by developing innovative therapies. Join us in the Biopharmaceuticals R&D department and contribute to our growing pipeline!
Ersättning Not Specified
Så ansöker du Sista dag att ansöka är 2025-04-01
Klicka på denna länk för att göra din ansökan Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "R-222223".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Astrazeneca AB (org.nr 556011-7482)
Arbetsplats AstraZeneca
Jobbnummer 9227977