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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical pharmacology, including pharmacokinetics and pharmacometrics, with a strong focus on designing and executing clinical pharmacology plans and regulatory documentation. Proven ability to lead multifunctional teams and apply innovative analytical methods to optimize drug development processes.
Highest-signal resume keywords
Clinical Pharmacology ExpertisePharmacokinetics ModelingNONMEM ExperienceRegulatory Document DevelopmentQuantitative Pharmacology Approaches
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
PharmacokineticsPharmacometricsClinical PharmacologyMechanistic PK/PD ModelingPopulation ModelingClinical Trial SimulationsDose-Range Finding StrategiesAnalytical Methods OptimizationProtocol AuthoringBiomarker Measurement Strategies
Soft Skills
Excellent Written CommunicationVerbal Communication SkillsPresentation SkillsCoaching and Mentoring
Tools & Technologies
NONMEMR
Certifications & Qualifications
M.D.Ph.D.Pharm.D.
Industry Keywords
Drug DevelopmentClinical Pharmacology PlansPK/PD AnalysesRegulatory GuidelinesSOPsFirst-in-Human StudiesMIDD PlansGlobal Meetings
About the role
Key responsibilities & impact- Act as Clinical Pharmacology representative on Clinical Sub Teams, Development Teams, and other multifunctional teams
- Provide clinical pharmacology expertise, leadership, and deliverables for assigned projects
- Design and execute clinical pharmacology plans and implement best practices
- Ensure sufficient preclinical PK/PD knowledge for safe human administration and predictive model development before first-in-human studies
- Plan and oversee project-level clinical pharmacology activities, including development plans, PK/PD analyses, and PK/immunogenicity/biomarker measurement strategies
- Plan and oversee study-level activities, including protocol authoring, clinical phase oversight, and reporting
- Ensure appropriate dose-range finding strategies and optimal patient doses and dosage regimens
- Design and implement end-to-end MIDD plans
- Apply innovative analytical methods to optimize doses, dosage regimens, and study designs
- Contribute to regulatory documents, including briefing documents, regulatory queries, Investigator’s Brochures, INDs, NDAs, and MAAs
- Develop new methodologies through internal and external collaborations
- Coach less experienced colleagues and team members
- Stay current with literature, regulatory guidelines, internal guidance, and SOPs
- Influence the external environment through publications, presentations, scientific societies, and industry consortia
Requirements
What you’ll need- M.D./Ph.D., or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline
- Pharm.D. or equivalent training/experience in pharmacokinetics, pharmacometrics, clinical pharmacology, engineering, or related discipline
- 5+ years of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology
- 1+ year of industry experience in clinical pharmacology and/or clinical PK/PD and/or Pharmacometrics/Systems Pharmacology
- Strong quantitative skills and expertise in mechanistic PK/PD modeling/systems pharmacology, literature meta-analyses, population modeling, and clinical trial simulations
- Experience using NONMEM and R
- Intimate knowledge of drug development
- Experience applying quantitative pharmacology approaches to knowledge integration
- Excellent written and verbal communication skills
- Demonstrated presentation skills
- Ability to attend global meetings periodically across different time zones
- 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- Global Performance Plan bonus target of 17.5% of base salary
- Share-based long-term incentive program
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation
- Paid holidays
- Paid personal days
- Paid caregiver/parental leave
- Paid medical leave
- Medical, prescription drug, dental, and vision coverage
- Relocation assistance may be available based on business needs and/or eligibility
- Employee referral bonus eligibility
