Oncology Clinical Development Scientist

7 days ago

Cambridge, Cambridgeshire, United Kingdom Pfizer Full time

Job Summary:

The Late-Stage Clinical Scientist (non-MD, Senior Manager) is a critical role within the Oncology portfolio, responsible for ensuring the scientific integrity and quality of clinical trials. This position requires a strong understanding of clinical procedures, ICH guidelines, and global regulations.

Key Responsibilities:

  • Maintain current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
  • Partner with clinical and medical colleagues, clinical operations, and other functional lines for the successful implementation and execution of clinical trials.
  • Ensure scientific oversight, data integrity, and quality of clinical trials.
  • Author protocols, study-level informed consent documents, and contribute to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents.
  • Review and query safety and efficacy data in support of the clinical data review strategy and collection of quality data and review of emerging clinical data and trends.
  • Present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
  • Analyze the emerging safety profile of the drug, keeping clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
  • Follow relevant SOPs and regulations, and have an excellent understanding of and comply with applicable trainings.
  • Lead or actively participate in portfolio- and enterprise-level workgroups aimed at optimizing PFE clinical development procedures.
  • May supervise, mentor, and/or develop others.

Requirements:

  • Science degree (PhD, PharmD, or equivalent) and minimum of 2-year Clinical Research experience in industry/CRO, OR BA/BS and minimum of 7-year Clinical Research experience in a similar role in industry/CRO.
  • Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor.
  • Excellent knowledge of clinical procedures, ICH guidelines, GCP, and familiarity with FDA, EMA, and global regulations.
  • Demonstrates a passion for helping patients with cancer and for the science of oncology.
  • Proven analytical skills with the ability to work on large data sets.
  • Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery.
  • Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English.
  • Has a global perspective and mindset, works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies.

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