Oncology Clinical Development Scientist (Senior Manager)

Role Summary

Oncology Clinical Development Scientist (Senior Manager). You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the Oncology portfolio. This role requires partnering with other clinical and medical colleagues, clinical operations and other functional lines to ensure successful implementation and execution of the trials within the assigned program.

Responsibilities

• Clinical development expert for assigned studies, maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Partner 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).
• Represent the study team in governance meetings and submissions; partner with/support the Development lead/Medical Director regarding study and disease area strategy.
• 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, as appropriate.
• Set the clinical data review strategy and lead the team in the collection of quality data and review of emerging clinical data and trends; review data, present and discuss relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
• In close partnership with medically qualified colleagues, 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; maintain an excellent understanding of applicable trainings; seek opportunities to improve quality and efficiency of clinical procedures; lead or actively participate in portfolio- and enterprise-level workgroups aimed at optimizing clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.

Qualifications

• PhD/PharmD in a relevant science discipline with minimum of 2 years Clinical Research experience in industry/CRO, OR
• MS in a relevant science discipline with minimum of 3 years Clinical Research experience in industry/CRO, OR
• BA/BS in a relevant science discipline with minimum of 5 years Clinical Research experience in a similar role in industry/CRO
• Clinical Research experience in the phase 2-3/pivotal space in Oncology, ideally on the sponsor side with a track record of successful regulatory submission, inspection, and regulatory approval
• Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
• Extensive understanding of related disciplines, e.g., Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance
• Experience working on large data sets
• Proficiency with Microsoft Office and relevant scientific software
• Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery
• Experience leveraging a variety of communication tools and techniques to communicate results
• Experience solving problems collaboratively and handling conflict constructively
• Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
• Experience working proactively and independently, organizing tasks, time and priorities of self and others
• Experience building partnerships across the company to achieve the needs of the program

Skills

• Demonstrates passion for helping patients with cancer and for the science of oncology
• Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned
• Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of clinical responsibilities
• Promotes team health and exemplifies Pfizer’s leadership behaviors and actionable attitudes
• Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies
• Demonstrates foresight and judgment to make complex decisions
• Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes
• Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development
• 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

Additional Requirements

• Work Location Assignment: Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week