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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Research with a focus on Oncology, including protocol authorship, regulatory submissions, and data integrity oversight. Proficient in leading teams and collaborating across functions to ensure successful clinical trial execution and compliance with ICH guidelines and GCP.
Highest-signal resume keywords
PhD/Pharm D In Relevant Science DisciplineClinical Research Experience In OncologyRegulatory Submission And Approval ExperienceLeadership Experience In Clinical TrialsKnowledge Of ICH Guidelines And GCP
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial OversightData Integrity ManagementProtocol AuthoringRegulatory Document PreparationClinical Data Review StrategyStatistical AnalysisClinical Operations KnowledgeSafety AnalysisQuality AssuranceExperience With Large Data Sets
Soft Skills
Effective CommunicationPresentation SkillsOrganizational SkillsCollaborative Problem SolvingConflict Resolution
Tools & Technologies
Microsoft OfficeScientific Software
Industry Keywords
Clinical ResearchOncologyPhase 3 TrialsSolid Tumor TrialsHematology TrialsFDA RegulationsEMA RegulationsICH GuidelinesGCP ComplianceClinical Development Procedures
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide scientific oversight, data integrity and quality oversight for clinical trials supporting late-stage oncology development programs
- Maintain current scientific and clinical knowledge for assigned therapeutic and disease areas
- Partner with clinical and medical colleagues, clinical operations, and other functions to implement and execute clinical trials
- Represent study teams in governance meetings and submissions
- Support Development leads and Medical Directors on study and disease-area strategy
- Author protocols, informed consent documents, clinical study reports, regulatory responses, and other clinical and regulatory documents
- Support Health Authority meeting preparation and participation
- Set clinical data review strategy and lead collection and review of emerging clinical data and trends
- Review and query data and present relevant findings to teams, governance bodies, and internal and external stakeholders
- Analyze emerging drug safety profiles with medically qualified colleagues and communicate changes to clinical and safety colleagues
- Follow SOPs and regulations and improve clinical development procedures
- Lead or participate in portfolio- and enterprise-level workgroups
Requirements
What you’ll need- 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
- Solid tumor or hematology clinical trial experience
- Experience leading a team
- Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
- Extensive understanding of Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, and Quality Assurance
- Experience working on large data sets
- Proficiency with Microsoft Office and relevant scientific software
- Effective communication, presentation, and organizational skills
- 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 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
- Candidates must be authorized to be employed in the U.S. by any employer
- Permanent work authorization in the United States required; U.S. work visa sponsorship is not available now or in the future
Benefits
Comp & perks- Pfizer Global Performance Plan bonus target of 20.0% of base salary
- Share based long term incentive program
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Medical, prescription drug, dental and vision coverage
- Relocation assistance may be available based on business needs and/or eligibility
- Hybrid work arrangement
