Medical Director, Respiratory, Early Clinical Development

Are you ready to shape and deliver the AstraZeneca Respiratory pipeline? If you are a motivated drug developer, this is an excellent time to join!

In the Respiratory Translational Sciences and Clinical Development (TSCD) team, we investigate the drivers of key respiratory diseases, with access to pioneering science, innovative drug discovery approaches and key collaborations with academic centers around the world. We investigate a wide range of drug modalities – small molecules, biologics, oligonucleotides and other modalities – across multiple diseases with high unmet medical need.

TSCD in Respiratory 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 later phase clinical studies. We are a diverse team of experienced physicians, clinical scientists and translational medicine scientists who collaborate with scientists and late clinical development to define our early phase clinical development strategies, design innovative clinical trials, develop and validate new clinical endpoints and translate scientific ideas to proof‑of‑concept studies in targeted patient populations.

As a Medical Director, you will provide medical and scientific input to preclinical and clinical stage assets within the context of a respiratory clinical team. This will include the creation of overall clinical development plans and clinical study design as well as 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.

Experience in Respiratory Medicine is strongly preferred. The successful candidate will thrive in a fast‑paced, proactive can‑do culture, be a strong communicator, and a 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 across functional teams.
• Closely follow medical developments within respiratory diseases and disseminate new information within Clinical Development and the wider organization 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 Respiratory TSCD 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/program design.
• Support qualification of pharmacodynamic/disease markers for early assessment of efficacy.
• Support establishing scientific collaborations with academic collaborators to support key advancing translational science activities.
• As available, provide clinical strategic input to in‑licensing opportunities.

• MD or PhD in respiratory sciences or related field.
• Minimum of 5 years experience in industry or relevant clinical or research experience.
• Understanding of the drug development process, including clinical and non‑clinical study design and execution.
• 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.
• Understanding of FDA, MHRA and ICH GCP guidelines to ensure the appropriate conduct of global clinical studies in the United States, Europe, and the rest of the world.
• Attention to detail, internal drive to generate high‑quality work, and sense of passion and urgency to achieve team and program goals.
• Demons…