Medical Director, Rheumatologist for Early Clinical Development

Job title:

Medical Director, Rheumatologist for Early Clinical Development

Company

AstraZeneca

Job description

Are you a Rheumatologist with Clinical Development experience with novel therapies including biologics ready to shape and deliver the AstraZeneca Immunology pipeline?If you are a motivated drug developer, this is an excellent time to join!Who We AreIn 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 2b), while collaborating closely with our late phase clinical development colleagues who guide our phase 3 clinical studies. We are a diverse team of 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.What You Will DoAs the 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 internal and external partners and clinical research organizations.As a Rheumatologist you will have clinical development experience of novel and complex biologic therapies in relevant indications, eg systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Sjogrens or Systemic Sclerosis. . The successful candidate will thrive in a fast-paced, proactive can-do culture, be a strong communicator and collaborator.

• 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.
• Provide clinical strategic input to in-licensing opportunities.

Basic Qualifications:

• Qualified Physician (MD) and Rheumatologist
• A PhD in a related Rheumatology/Autoimmune subject
• At least one year of experience in early phase clinical development of complex biologics in a hands-on role including the design, delivery and interpretation of Ph1 / Ph2 studies in relevant indications such as systemic lupus erythematosus and 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 working with 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.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!Where can I find out more?R&I at AstraZeneca: https://www.astrazeneca.com/our-therapy-areas/respiratory-and-immunology.htmlDate Posted
19-Sep-2024Closing Date
25-Sep-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.

Expected salary

Location

Cambridge

Job date

Sun, 22 Sep 2024 22:33:16 GMT

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