As a Global Clinical Program Lead for COVID-19, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. The Biopharmaceuticals Research & Development, Late-stage Development, Respiratory & Immunology (R&I) function drives late-stage development of our innovative pipeline, including for COVID-19, transforming exciting science into valued new medicines and ensuring patients around the world can access them. The role could be located in Gaithersburg, MD, or Durham, NC.

The Global Clinical Program Lead is responsible for managing global or regional therapeutic or research projects or acting as an expert involved in the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. You will ensure projects adhere to Good Clinical Practice and regulatory requirements. In this role you will be able to deputize for global clinical head (GCH) and independently lead development activities for an indication or subset of the clinical development plan. You will be responsible for overseeing development of the functional strategy or acting as a renowned expert in own field.

Typical accountabilities

• Defines strategies or leads AstraZeneca’s response to complex technical issues for specific medical aspects in relation to current projects, new projects and broader therapeutic area strategy
• Provides expert advice in the therapeutic area, influencing the development according to the global business and Global Clinical Development plan
• Closely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plans
• Liaises with the internal and external medical community to follow developments within areas of expertise
• Contributes to or manages the development of the senior management team in area of expertise
• Leads regulatory communication and preparation of higher-level documents
• Supports the development of clinical documents in assigned project

• Physician with specialist training in Pulmonary medicine/ allergy/ immunology /internal medicine OR a scientist with a higher degree and significant clinical development experience in the above specialties
• Minimum of 3 and ideally more than 5 years in Industry, with experience in leading clinical trials to support approval (Phase 2-4)
• Experience in leading a clinical program to support an indication, including overall design, clinical development plan and Target Product Profile
• Experience in writing clinical aspects of briefing documents for regulatory interactions and played a critical role in writing sections of a submission dossier
• Previous experience in working cross functionally including leading cross functional study teams
• General understanding of medical statistics, safety, regulatory requirements.

Desirable for the role

• PhD or PharmD in scientific discipline
• Extensive general medical knowledge