You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within our Oncology portfolio.
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.

Requirements

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 3 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and 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 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

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

Clinical ResearchOncologyRegulatory submissionICH guidelinesGCPFDA regulationsEMA regulationsData analysisScientific writingClinical data review

Soft Skills

Effective communicationPresentation skillsOrganizational skillsProblem-solvingConflict resolutionCollaborationIndependenceTime managementPrioritizationPartnership building

Certifications

PhDPharm DMSBABS