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

Role Summary

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

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

• PhD/Pharm D in a relevant Science discipline and minimum of 2 years Clinical Research experience in industry/CRO, OR
• MS in a relevant Science discipline and minimum of 5 years of Clinical Research experience in industry/CRO OR
• BA/BS in a relevant Science discipline and minimum of 7 years 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 and 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.

Competencies

• 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 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.

Education

• Highest relevant degree tied to qualifications above.

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.