Oncology Late-Stage Clinical Scientist (Director, Non MD)

Role Summary

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 Late-Stage Oncology portfolio.

Responsibilities

• Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Effectively 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, partners with/supports the Development lead/Medical Director regarding study and disease area strategy.
• Author 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.
• Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
• In close partnership with medically qualified colleague/s, analyze 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).
• Follow 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.

Qualifications

• Required: PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO
• Required: MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO
• Required: BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO
• Required: Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the sponsor side with a track record of successful regulatory submission, inspection, and regulatory approval
• Required: Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
• Required: Extensive understanding of related disciplines (Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance)
• Required: Experience working on large data sets
• Required: Proficiency with Microsoft Office and relevant scientific software
• Required: Effective communication, presentation, and organizational skills; experience leveraging a variety of communication tools
• Required: Experience solving problems collaboratively and handling conflict constructively
• Required: Track record of scientific productivity (publications, posters, abstracts, presentations)
• Required: Experience working proactively and independently, organizing tasks, time and priorities
• Required: Experience building partnerships across the company to achieve program needs
• Preferred: Experience in Hematology Oncology

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
• Autonomous delivery, problem-solving, and agile decision-making in clinical responsibilities
• Promotes team health and exemplifies leadership behaviors
• Leverages knowledge and support from others related to objectives, strategy, issues, and policies
• Foresight and judgment to make complex decisions
• Promotes innovation and takes appropriate risks to improve processes
• Embraces evolving technologies and best practices to improve efficiency and quality
• Global perspective and ability to work in diverse teams

Education

Additional Requirements

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