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Clinical Research Scientist Late-Stage Oncology
2 months ago
Job Summary:
The Late-Stage Clinical Scientist (non-MD, Senior Manager) is a critical role in Pfizer's Oncology portfolio, responsible for scientific oversight, data integrity, and quality of clinical trials. This position requires a strong background in clinical research, with a focus on late-stage oncology trials.
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.
- Responsible for 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.
- Support preparations for Health Authority meetings and participate as appropriate.
- 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, have an excellent understanding of and comply with applicable trainings, seek opportunities to further improve quality and efficiency of clinical procedures.
- 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; scientific productivity via publications, posters, abstracts, and/or presentations.
- Has a global perspective and mindset works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies.
- Has solid understanding of related disciplines, e.g., clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance.
