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
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
Support preparations for Health Authority meetings
Set the clinical data review strategy and lead 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
Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings
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, 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
401(k) plan with Pfizer Matching Contributions
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
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