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Global Clinical Program Lead

Gaithersburg, MD, USA | AstraZeneca

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
  • Experience:
    3-5 years
Job Description:
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What you’ll do

As a Global Clinical Program Lead , 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. Transforming exciting science into valued new medicines and ensuring patients around the world can access them.

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

Essential for the role

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 and/or PharmD in scientific discipline

Extensive general medical knowledge

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