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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including protocol development, safety data review, and regulatory compliance. Proven ability to lead cross-functional teams and provide medical guidance in biopharmaceutical research.
Highest-signal resume keywords
Clinical Trial ManagementProtocol DevelopmentSafety Data ReviewRegulatory SubmissionsLeadership and Mentoring
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical ResearchBiopharmaceutical DevelopmentData MonitoringRisk ManagementStatistical Analysis PlansClinical Study ReportsProtocol TrainingAdverse Event ReportingQuality AuditsProject Management
Soft Skills
LeadershipMentoringConflict ResolutionDecision-MakingOrganizational Change
Certifications & Qualifications
Medical Degree (MD, DO, MBBS, MBChB)Licensed to Prescribe Medicines
Industry Keywords
Clinical TrialsICH/GCPCardiometabolic DiseaseRegulatory ComplianceGlobal RegulationClinical DevelopmentStudy DesignSite SelectionExternal Stakeholder EngagementTrial Master File Compliance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide medical monitoring and timely medical guidance on one or more clinical trials
- Review clinical trial data, safety data, quality events, audits, and inspections
- Conduct periodic safety data reviews and ongoing clinical/medical data reviews
- Lead or contribute to clinical execution and program-level clinical deliverables
- Develop protocols, protocol amendments, administrative change letters, and investigator letters
- Represent study teams in protocol governance and support study and disease-area strategy
- Participate in protocol-related key opinion leader and Health Authority interactions
- Develop informed consent documents and respond to external stakeholder requests
- Provide clinical guidance for statistical analysis plans, tables, listings, and figures
- Set clinical data review strategy, lead emerging-data reviews, query data, present findings, and support database lock
- Develop safety and risk management plans; review safety data, safety narratives, serious adverse events, and risk mitigations
- Establish and manage External Data Monitoring and Adjudication Committees
- Develop site selection criteria, provide clinical input to site selection, and ensure protocol training
- Plan investigator meetings and deliver initial and ongoing protocol training
- Serve as primary clinical contact for investigators and study teams and manage clinical responses
- Establish and manage protocol deviation categories, reporting, reconciliation, and trend reviews
- Ensure Trial Master File compliance for clinical documents
- Provide clinical input to Clinical Study Reports and disclose safety and efficacy data
- Support audits and inspections and respond to findings
- Contribute to clinical sections of regulatory filings and continuous improvement activities
- Manage, supervise, mentor, or develop clinical colleagues and contingent workers
Requirements
What you’ll need- Primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university
- 4+ years of experience in the biopharmaceutical industry in clinical research and development
- Licensed by a licensing body/health authority to prescribe medicines independently of supervision for at least 2 years after the intern/house officer/foundation period
- Must live within commuting distance of the assigned work location
- 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
- Global travel may be required
- Cardiometabolic disease experience preferred
- Maintained registration/medical license in good standing preferred
- Clinical research experience in biopharmaceutical study design, start-up, conduct, and close-out preferred
- Experience with regulatory submissions and inspections preferred
- Scientific productivity through publications, posters, abstracts, and/or presentations preferred
- Knowledge of clinical development, global and regional regulation, and ICH/GCP preferred
- Clinical, administrative, and project management capabilities preferred
- Experience launching, managing, and training clinical development teams preferred
- Pharmaceutical development track record preferred
- Knowledge of principal disease areas and drug development science and regulations preferred
- Ability to manage cross-functional teams, complex projects, milestones, budgets, and resources preferred
- Leadership, mentoring, delegation, conflict resolution, decision-making, and organizational change capabilities preferred
Benefits
Comp & perks- Global Performance Plan bonus target of 25.0% 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
