Detail

Salary
negotiable
Location
Durham, NC, USA
Posted by: Astra Zeneca
12 Feb
87 Views
13 Apr EXPIRED

Global Clinical Program Lead: COVID-19

Durham, NC, USA
Job Description


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
Job ID Reference
1469
Desired Skills & Experience
  • 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
Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Durham, NC, USA