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Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial oversight, regulatory submissions, and data integrity within oncology development. Proficient in collaborating across diverse teams and managing clinical operations while adhering to ICH/GCP guidelines.
Highest-signal resume keywords
PhD/Pharm D In Relevant Science DisciplineClinical Research Experience In OncologyRegulatory Submission ExperienceKnowledge Of ICH Guidelines And GCPProficiency With Microsoft Office And Scientific Software
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 expertise for assigned studies and therapeutic/disease areas
- Partner with clinical, medical, clinical operations, and other functional colleagues to implement and execute clinical trials
- Represent study teams in governance meetings and regulatory submissions
- Support Development Leads/Medical Directors on study and disease-area strategy
- Author protocols, study-level informed consent documents, investigator brochures, site training materials, clinical study reports, regulatory responses, and other clinical/regulatory documents
- Support Health Authority meeting preparation and participate as appropriate
- Set clinical data review strategies 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/external stakeholders
- Analyze emerging drug safety profiles with medically qualified colleagues and communicate changes to clinical and safety colleagues
- Follow SOPs, ICH/GCP requirements, and applicable regulations
- Lead or participate in portfolio- and enterprise-level workgroups to optimize clinical development procedures
- Serve as a subject matter expert or business process owner for relevant SOPs or procedures
- Work collaboratively across diverse teams and geographies while influencing, coaching, and guiding colleagues
Requirements
What you’ll need- 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
- Experience in oncology clinical trial development, solid tumor and/or heme
- Clinical Research experience in the phase 3/pivotal space in Oncology, ideally on the side of the sponsor, 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 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 through 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
- U.S. work visa sponsorship is not available now or in the future
- Requires permanent work authorization in the United States
Benefits
Comp & perks- Bonus target of 17.5% of base salary through Pfizer’s Global Performance Plan
- Eligibility to participate in Pfizer’s 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
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 AuthoringClinical Data Review StrategiesOncology Clinical Trial DevelopmentRegulatory Approval ProcessesStatistical AnalysisQuality AssuranceScientific WritingProblem Solving
Soft Skills
Effective CommunicationPresentation SkillsOrganizational SkillsCollaborative Problem SolvingConflict Resolution
Industry Keywords
Clinical ResearchOncologyICH GuidelinesGCPFDA RegulationsEMA RegulationsClinical OperationsBiostatisticsStudy ManagementPharmacology