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
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
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 contribute to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents
Set the clinical data review strategy and lead the team in the collection of quality data and review of emerging clinical data and trends

Requirements

PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, OR MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO OR BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO
Clinical Research experience in the phase 3/pivotal space in Oncology
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

Benefits

401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental and vision coverage

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchdata integrityclinical trial oversightprotocol authoringclinical study reportsregulatory submissionsdata review strategyOncologyGCPICH guidelines

Soft Skills

collaborationcommunicationleadershiporganizational skillsproblem-solving

Certifications

PhDPharm DMSBABS