AdressAre you ready to shape and deliver the AZ Immunology pipeline? AstraZeneca is seeking a Senior Medical Director in Early Clinical Development (Respiratory and Immunology/R&I) for one or more immunology programs. This includes the development of novel biologic and small molecule therapies for autoimmune and/or inflammatory diseases. This is an excellent opportunity for an experienced and motivated drug developer.
Accountabilities:
As the Senior Medical Director, you will provide medical and scientific input to preclinical and clinical stage assets focused on Rheumatology/Clinical Immunology. You will take responsibility for Clinical Development in cross-functional teams to support early phase Clinical Development activities. These 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. Experience in Rheumatology drug development is a must and will ideally include trials in diseases such as systemic lupus erythematosus (SLE) and Rheumatoid Arthritis (RA). The successful candidate will thrive in a fast-paced, proactive can-do culture, be a highly effective internal and external team player as well as a strong communicator and collaborator.
Responsibilities:
Responsible for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and product in compliance with GCP.
Provide guidance in the medical strategy and clinical/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 organisation to transform trends and emerging data into agile and innovative clinical plans.
Work closely and collaborate across early and late R&I Clinical Development, partner functions and wider AZ organization to ensure design and delivery of Clinical Development plans with high quality and speed.
Represent Early R&I Clinical Development to external partners, including Investigators, key external experts and patient advocacy groups.
Medical Lead for regulatory communication and preparation of higher level documents
Ensures internal and external peer review of potential study/programme design.
Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.
As available, provide clinical strategic input to in-licensing opportunities.
Essential Skills/Experience:
Advanced degree in Rheumatology/Clinical Immunology (MD or PhD).
A background working in Clinical Development a must. Experience in Rheumatology/Immunology in a pharmaceutical or biotechnology company including significant knowledge and experience in the design and execution of clinical trials in diseases such as systemic lupus erythematosus or rheumatoid arthritis.
Understanding of the entire drug development process, including clinical and non-clinical study design and execution.
Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and efficient clinical trial design, and Clinical Development plans with clear data-driven decision rules.
Thorough command of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies in the United States, Europe and rest of world.
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 regarding new strategies to ensure consistent communication.
Demonstrated track record in delivering results.
Outstanding verbal and written communication skills.
Excellent analytical, problem solving and strategic planning skills.
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.
Why AstraZeneca?
Join the team unlocking the power of what science can do. We are working towards treating, preventing, modifying and even curing some of the world's most complex diseases. Here we have the potential to grow our pipeline and positively impact the lives of billions of patients around the world. We are committed to making a difference. We have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. It's our combination of curiosity and courage that drives us, inspired by the possibility of doing things that have never been done before. Empowered to step up, we free ourselves from fear of failure to dig deep into the biology of complex diseases and make bold decisions. Celebrating our successes and failures along the way.
Ready to make a meaningful impact on patients' lives? Apply now!
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
