Principal Medical Scientist – Early Clinical Development (Oncology)
Cambridge, United Kingdom
We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has big impact on science and medicine.
Principal Medical Scientists are a resource for the Project Team, as physician-delegates working synergistically with physicians as an expert in medical scientific aspects of the compound and its development. The accountabilities are broad, however the core accountability is the medical & scientific support for the development and maintenance of the non-AstraZeneca sponsored clinical trial strategy (e.g., Investigator Sponsored Studies), review of clinical trial proposals and external relationship management.
Additional physician-delegate tasks may include the set-up, conduct, reporting and interpretation of clinical trials, liaison with discovery, regulatory, clinical and commercial colleagues, input to regulatory documentation, and review of literature pertaining to the compounds under development. Oncology Medical Scientists in early clinical development typically focus on the Phase I and Phase II development plan up to proof of concept. These individuals must ensure that all project activities are undertaken to the highest ethical and safety standards and in compliance with GCP, regulatory & appropriate pharmaceutical code requirements. The job-holder can expect to get broad international exposure to other functions involved in the drug development process within AstraZeneca, gaining an overview of how strategic direction is set and how decisions are made during drug development.
Depending on needs of the specific project, the Principal Medical Scientist may take on tasks delegated by the project physician where appropriate:
• Lead the generation of external clinical development strategy for a programme
• Lead clinical proposal reviews, and scientific discussions with external Investigators
• Support key contacts with opinion leaders, and help develop alliances as appropriate
• Represent the project internally and support oncology drug development externally as a medical scientific expert. Liaise with bioscientists to provide clinical input to the development of the line of sight.
• Ensure and champion consistent medical & scientific aspects of the clinical study plans across the programme
• Provide medical scientific leadership to data and safety reviews ensuring consistency throughout the process
• Provide medical science support to specific studies when requested by the physician as appropriate
• Communicates information to multiple teams in various areas of the drug development process, ensuring all involved parties are aware of important developments
• Represent AstraZeneca as a support for external meetings such as advisory boards and
• Guide aspects of the Clinical Development Plan (CDP) and Clinical Study Protocols in keeping with the approved CDP and ensuring linkage of trial data to target product claims/profile
• Input medical scientific information to internal documentation such as risk management plans, Investigator Brochures and strategic planning documents
• Follow important developments and trends in the medical & scientific literature
• Write and check content and quality of publications and input to development of publication strategy
• Understand early phase clinical trials – process and outcomes.
Education, Qualifications, Skills and Experience
• Relevant Clinical or Biomedical Ph.D or relevant Pharmacy, Nursing, MSc/MRes degree with proven R&D drug development experience
• Significant clinical drug development or medical affairs experience within a pharmaceutical company environment
• A degree of specialist knowledge of the medical and scientific activities related to Oncology
• A good understanding of more than one development function
• Ability to work collaboratively in a cross functional setting
• Capable of working both independently and with guidance in complex situations as part of a multi-disciplinary team to facilitate decision making and project deliverables
• Credibility in scientific environments.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country where the role is advertised.