Oncology Late-Stage Clinical Scientist (non-MD, Senior Manager)

ROLE SUMMARY

The Late-Stage Clinical Scientist (non-MD, Senior Manager) is responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Late-Stage Oncology portfolio.

ROLE RESPONSIBILITIES

• Clinical development professional maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Partners with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program.
• Responsible for scientific oversight, data integrity and quality of the clinical trial(s).
• Authors protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
• Reviews and queries 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; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
• In close partnership with medically qualified colleague/s, analyzes the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
• Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.
• May supervise, mentor, and/or develop others.

QUALIFICATIONS

• 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. both as a leader and a key contributor; works effectively with internal and external partners and investigators/medical professionals.
• Has solid understanding of related disciplines, e.g., clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance.

PHYSICAL/MENTAL REQUIREMENTS

• Proficient with basic IT; efficiently using a computer and telecommunications (voice and video)  
• Has the flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned.
• Must have the relevant personality features and competencies supporting the responsibilities:

• Demonstrates effective problem-solving, and agile decision-making in execution of Clinical responsibilities.
• Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies.
• Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development.
• Promotes team health and exemplifies Pfizer’s leadership behaviors and actionable attitudes.  
• Has foresight and judgment in complex decisions:

• Leverages a variety of communication tools and techniques to communicate results.
• Builds partnerships across the company to achieve the needs of the program.
• Collaborative problem solving (handles conflict constructively)
• Promotes innovation and takes appropriate risks to challenge the status quo to enhance the efficiency of current processes.
• Ability to work proactively and inde