Scientific Director Early Clinical Development
hace 2 semanas
**Impact patients’ lives every day**:
Make a more meaningful impact in your career, with greater ownership and accountability to make a contribution. And in returnwe’re looking for people driven by making a difference to patients and society, dedicated to doing the right thing.
**Who we are**:
We cannot stand still. We are always building our abilities, dedicated to sharing and developing.
**What we do**:
In our work we aim to bring wider benefits to society - building healthy communities and limiting our impact on the planet. We are committed to leading the quest to meet rising global demand for effective healthcare.
**How we do it**:
A place of ownership, each of us is empowered to lead at every level. Backed with great tools, resources and investment, we get things done.
Are you a passionate Scientist who would like to work at the cutting edge of science to develop ground-breaking medicines of the future? As a global, science-led biopharmaceutical company, we in Early Clinical Development are the beating heart of the business and there’s no better place to work to bring forward new medicines.
At AstraZeneca, your innovative contribution will ultimately have the potential to reach billions of patients in need across the globe. That is why we love it - this is the place to make a greater impact. Are you ready to join us and see what science can do?
We are looking to hire a Scientific Director or Senior Scientific Director with a background in Immunology and Clinical Drug Development, to join our team within Early Clinical Development, Immunology.
We are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with you. We are part of the BioPharmaceutical R&D unit. Here, you will get the opportunity to work in a truly international environment and meet and discuss with key opinion leaders, medical colleagues and authorities in basic science, as well as commercial, regulatory, and other functions to bring new medicines to life.
**What you’ll do**
As a Scientific Director / Senior Scientific Director with a background in Immunology, you will have responsibilities for the design, delivery and interpretation of clinical studies in Early stage (up to Ph3) within AstraZeneca´s global organization. You will be responsible for the scientific strategy as a disease area expert and deliver the clinical scientific strategies of the Clinical Development Plan to the project team.
You will operate in a wide range of aspects in pharmaceutical medicine and lead a multitude of contacts within and outside of AstraZeneca such as with our senior management team, regulatory and finance colleagues, academic partners and CROs.
For Immunology at AZ, you would be a key part of the Team working across multiple diseases in specialties focused on GI diseases (e.g., Crohn’s disease, Ulcerative Colitis), Rheumatology (e.g., Systemic Lupus Erythematosus, Rheumatoid Arthritis), and Dermatology (e.g., Atopic Dermatitis, Psoriasis). You will be familiar with relevant Regulatory guidelines for drug development in key Gastroenterological diseases, current treatment guidelines, and relevant competitor trial designs and data as these are continually evolving. As such, this will enable you to build novel and innovative Early Clinical development plans.
**We rely on you to**:
- Design and implement the clinical science aspects of the Clinical Development Plan (CDP) and Clinical Study Protocols and ensure linkage of trial data to target product claims
- Lead clinical scientific input to the set-up, design (target population, translational biomarker selection, quantitative decision making), study analysis planning and reporting, and regulatory submissions of our clinical studies
- Closely follow medical and scientific developments within assigned areas and disseminate new information within Clinical Development to transform trends and emerging data into new plans
- Build positive relationships and networks with the internal and external medical and scientific community to follow developments within areas of expertise, and help develop alliances
- Support clinical components of regulatory communication and preparation of higher-level documents
- Ensure internal and external peer review of study/programme design
- Write and check content and quality of product-related publications, and input into development of the publication strategy
**Essential for the role**:
- A Clinical or Biomedical PhD or MSc/MRes in Immunology, and in the setting of one of the following: Gastroenterology, Rheumatology or Dermatology
- Several years of experience in clinical drug development, medical affairs, or medical research experience within a pharmaceutical company environment.
- Leadership experience alongside proven teamwork and collaboration skills.
- You are required to travel nationally and internationally.
**You also possess**:
- Significant experience in the design, monitoring,
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